Medical laboratories and testing companies must have complete control over their documents and protocols to ensure the quality standard of the organization. Laboratory document control is a critical process to adhere to regulatory requirements, such as GLP compliance, ISO 15189:2012, and 21 CFR Part 11.

Leading medical companies are already using software to automate their workflows, increasing the quality management, reproducibility, and repeatability of the processes at hand.

It is time for all companies to start using these systems in their routines.

In this article, we will learn more about the definition of laboratory document control, its importance in daily activities, the types and regulatory requirements for each document and record, best practices, and what to look for when implementing a digital system.

Note: If you need to streamline your document control workflow, it is smart to invest in efficient quality management software. With SimplerQMS, you have an all-in-one QMS software with robust document control capabilities – book a demo to see it in action.

We will cover the following topics:

• What is Laboratory Document Control?
• The Importance of Laboratory Document Control
• Types of Laboratory Documents and Records
• General Document Control Requirements
• Laboratory Document Control Best Practices
• Implementing a Laboratory Document Control Software

What is Laboratory Document Control?

Laboratory document control is a multi-step process for preparing, revising, approving, distributing, and maintaining necessary laboratory documentation.

But what are these essential documents?

Inside a medical laboratory and testing company, these are any written materials used to get the work done. They can be quality manuals, user guides, equipment calibration reports, Standard operating procedures (SOPs), test tracking systems, personnel files, and so on. More on this later.

To this day, some companies still manage documents and records using a traditional paper-based or hybrid system. However, this can cause some challenges, such as:

• Needing physical storage space. Keeping a massive amount of paper is a challenging task. It requires physical space in the company and a lot of organization from the employees to put everything in the right place. Moreover, in the worst-case scenario, you could lose years of documentation if a disaster such as a fire, occurs.
• Finding documents during an audit. It is necessary to present all the requested documents to the auditor, and picking up different binders in different locations is laborious and time-consuming. Having all documents at your disposal electronically certainly facilitates the audit process.
• Keeping documents free of error: Medical laboratories and testing companies need their documents to be accurate and correctly filled out to ensure their results and compliance with legislation. Documents filled out on paper can easily be done wrong due to spelling errors or mismatched information, affecting the entire workflow.

On the other hand, an electronic document control system provides a solution to help companies automate and standardize activities to improve the organization’s quality management.

Let’s think about a common situation for better understanding.

You must operate specific equipment following an SOP during your daily laboratory activities. Let’s say there is a revised version of this SOP made recently. You could access the latest version on the spot if it was created using a controlled document.

Document control software by SimplerQMS allows for robust controls of all documents that help you comply with applicable legislation. You can use the familiar Microsoft Office application to create, edit documents, and digitally sign off the documents.

The Importance of Laboratory Document Control

Commitment to quality is the basis of any life sciences organization. Since medical decisions are made based on laboratory results, it is necessary to be able to trust your procedures and documents.

Let’s see four benefits that highlight the importance of document control.

1. Increased Process Efficiency

Having effective document control allows the company to know where all its information is.

It can be laboratory results, adverse events in clinical trials, medical device complaints, or any other detail related to the product.

Imagine a company implementing a new laboratory assay and developing a new SOP. The lab manager will know this SOP’s progress by checking the employees’ updates and signatures.

2. Improved Regulatory Compliance

Companies must comply with national and sometimes international regulations, following guidelines and standards.

Having control of your documents avoids problems such as lost documents, misplaced information, and unfilled forms.

For example, employees can easily find and present any requested documents during an audit.

3. Enhanced Security

Documents in life science companies contain private information that everyone cannot access. Knowing which documents are restricted, where they are, and setting access levels is critical to ensure that there is no unauthorized use of sensitive information.

Ultimately, the best way to ensure your documents’ integrity is to control how they are produced, where they are stored, and who has access to them.

4. Streamlined Quality Management System

Laboratory document control and Laboratory Quality Management System (QMS) help clinical and medical laboratories ensure the highest quality standards of each result and document produced.

Suppose a laboratory using paper-based document control switches patient blood results, leading to wrong diagnoses and treatment. This kind of error would hardly occur using software for document control processes.

As we can see, manual or hybrid laboratory document management processes are prone to errors. The high volume of paper can lead to files being switched, lost, overdue, and filled in incorrectly.

A digital document control solution eliminates these problems by automating and streamlining document control workflows and allowing the laboratory staff to focus on more critical tasks.

Types of Laboratory Documents and Records

A laboratory can produce several different kinds of written materials. The purpose of documents and records is always to keep track of information and be able to find it when needed.

Good materials are written to be user-friendly, clear, accurate, and concise to ensure understanding for all staff.

Laboratory documents and records share the same goal but have slight differences.

Let’s understand this better.

Difference Between Documents and Records

Laboratory documents communicate updated knowledge with all laboratory staff, setting standard templates for reporting information.

These materials must be reviewed periodically when policies, processes, and procedures change.

It is also essential to know how these documents relate to each other:

• Policies are the general direction to follow regarding the quality system. Think about it as the “what to do” in every situation.
• Processes are events made over time to carry out a policy. They are the “how it happens” mainly represented in flowcharts.
• Procedures are step-by-step instructions for every activity performed in the laboratory. They are the “how to do it” in detail.

Some examples of the documents are:

• Quality manual
• Standard operating procedures
• Personnel files
• Etc.

Laboratory records collect data produced during laboratory tests. This information is permanent, does not require updating, and needs to be easily accessed.

Some examples of the records are:

• Equipment cleaning records
• Calibration checks
• Sample logs
• Patient records
• Etc.

Types of Documents

Training staff in clinical and medical laboratories is essential, and writing all the information is best to avoid being misunderstood or forgotten.

There are different types of laboratory documents. So, let’s have a look at some of them.

Standard Operating Procedures (SOPs)

Standard operating procedures (SOP) is one of the most known documents, it supplies the user with step-by-step instructions to perform any activity inside a laboratory. It ensures procedures are consistently done regarding the person performing them.

For example, collecting a blood sample following an SOP in a clinical laboratory helps guarantee that the staff had the right patient, filled out the proper form, and correctly identified the tube test.

Quality Manual

The quality manual provides guidelines for implementing the quality system and can be used internally and externally in audits.

It was first required by ISO 9001 for all quality management systems.

Quality Control (QC)

Quality control (QC) document reports the processes used to ensure the quality of products or systems. Laboratories must run quality control assays periodically and document all results, problems, and corrective actions using graphs to visually evaluate findings over time.

Typically, a test is performed with a known material to measure the accuracy of the test system.

Imagine a glucose quality control assay. To assure the equipment’s accuracy, you need to run a control reagent that produces results on an average of 100 mg/dL. After testing it ten times, the results range from 96 to 102 mg/dL, indicating that the equipment is accurate. It is necessary to document this data for future audits.

Quality Assessment (QA)

Quality Assessment (QA) document reports the quality and performance of all laboratory-related activities. Data collection and analysis are used to evaluate how effective are the current policies and procedures.

Furthermore, quality checks must be planned and conducted regularly on all processes.

For instance, your laboratory collects human urine samples and identifies each patient using a QR code. Periodically reviewing the related SOP regarding the QR code labeling can reduce the number of mismatched identifications.

Personnel Files

Clinical and medical laboratories must have documents about the employees, including, but not limited to:

• Annual safety training
• Continuing education
• Diplomas
• Records of any exposure incidents
• Vaccination status
• Etc.

Instrument Files

Each instrument used in the laboratory needs to have a document that reports its:

• Name
• Model
• Serial number
• Warranty information
• Supplier contact
• User guides
• And any other information related to its traceability

Equipment Maintenance

Equipment maintenance documents report the actions to ensure optimal instrument performance.

Usually, in the form of a log, it includes:

• How to perform proper maintenance
• Preventive maintenance
• Frequency
• Dates
• Responsible staff

Temperature and Humidity Logs

It is essential to maintain an appropriate environmental temperature and humidity to test accuracy and reproducibility. These parameters must be monitored and recorded daily.

If out of range, corrective actions must be taken and recorded in the log.

Proficiency Testing

Documents related to proficiency testing are part of a quality system for interlaboratory comparisons of performance and accuracy.

It works like this…

Laboratory sends samples to another external reference laboratory to perform the same assays. The goal is to achieve results within the standard range of the reference laboratory, thus meeting the clinical requirements for that test.

This process demonstrates the reliability of results and is a requirement for laboratory accreditation by ISO 17043:2010, ISO 15189:2012, and ISO 17025:2017.

Those are just a few examples of documents related to clinical and medical laboratories.

SimplerQMS laboratory quality management software allows you to handle all of your laboratory’s documents in one place, so you never have to worry about losing track of them again. It streamlines all documentation-related tasks, such as creating, approving, and implementing new SOPs, and many others.

Making your laboratory’s work easier than ever.

Types of Records

As we mentioned before, laboratory records are the written records of all data produced inside laboratories. This information is permanent and needs to be easily accessed in cases of audits.

Let’s see some examples to understand better.

Equipment Cleaning, Maintenance, and Sanitizing

Written records of major equipment related to equipment cleaning, maintenance, and sanitizing need to be included in individual equipment logs.

The report informs the proper time intervals of these actions to prevent malfunctions or contamination and must contain the date, time, product, and lot number.

Calibration Checks and Inspections

If the laboratory uses automatic, mechanical, and electronic equipment, those need to be routinely calibrated or checked. You must keep a written record of those inspections.

Let’s say your laboratory has a water purifier. It is necessary to routinely check ion and particle rejection rates and eventually change the filters. Each of these maintenance actions must be recorded and stored.

Equipment Identification

All major equipment used in the laboratory must be appropriately identified by a number or code to be traceable to a batch or test performed.

Control Testing

Laboratories need to establish specifications, standards, sampling plans, SOPs, or other laboratory control mechanisms required to perform the assays accurately.

It is necessary to record and justify the results and deviations of this control test.

Test Records

These kinds of records are the complete data from all tests carried out to assure compliance with specifications and standards.

Including a description of the sample received a statement of each method used in the testing, calculations performed, and staff signatures.

Imagine a laboratory receiving a dried blood spot sample from a newborn to process. A predefined analysis method is already in place in the lab, and control samples must be used alongside patient samples. After the test, the staff will sign off on the results.

Good Laboratory Practices (GLP)

Regulatory requirements from national and international agencies need to be available for the staff to consult.

One example is the GLP detailed in several FDA regulations, which we will discuss in the next section.

Information is the major product of clinical and medical laboratories.

Careful laboratory document control management with a modern electronic system is crucial to compliance and quality.

SimplerQMS document control software is a powerful tool to help you create all these mentioned documents and records and many others using document templates.

With SimplerQMS, all documentation is promptly available to your staff in a secure, cloud-based system. Allowing your team to easily access, modify, learn, approve, sign, and keep track of documents.

General Document Control Requirements

Laboratory document control is a mandatory process for clinical and medical laboratories to be accredited and follow regulatory legislation.

Some organizations, such as FDA and ISO, provide the standards and guidelines that companies need to ensure their good management and quality.

Let’s have a look at the requirements for laboratories.

ISO 9001:2015

We know that ISO 9001:2015 standard is not exclusive to laboratories, but it is the general requirement for a quality management system. And any company committed to quality can see it as a strategic decision to improve the overall performance of all activities.

This ISO represents better customer satisfaction by improving processes, addressing risk, and evidence-based decision-making.

ISO 17025:2017

ISO 17025:2017 standard outlines the requirements to prove the laboratory has the knowledge and skills to test and calibrate equipment.

A facility accredited with this ISO can generate valid results with competence, impartiality, and consistent operation.

ISO 15189:2022

Based upon ISO 9001 and 17025, ISO 15189:2022 is the international standard clinical and medical laboratories can use to develop their quality management systems and assess their own competence.

So, in it, we can find the requirements for:

• QMS
• Quality manual
• Internal audits
• CAPA procedures
• Nonconformities
• Complaints
• Suppliers
• Environmental conditions
• Personnel
• Equipment
• Examination procedures
• Reporting of results

Recommended Reading: What is ISO 15189? A Detailed Introduction (and Role of eQMS)

ISO 17043:2010

ISO 17043:2010 standard specifies the requirements for proficiency testing.

However, it does not identify any particular fields of application for laboratories.

Clinical and medical facilities can test the same or similar items under predetermined conditions in interlaboratory comparisons.

21 CFR Part 58

Under 21 CFR Part 58 are the Good Laboratory Practices for nonclinical laboratories that research food and color additives, animal food additives, human and animal drugs, human medical devices, biological products, and electronic products.

Regarding document control, it guides:

• Personnel files
• Quality assurance
• Equipment maintenance
• Calibration files
• SOPs
• Notebooks
• Animal use documents
• Reagent labeling
• Protocols and final reports

You will need to keep this written material for two to five years.

21 CFR Part 211

The regulations in 21 CFR Part 211 contain Good Manufacturing Practices for producing drug products for humans or animals.

It states that laboratories must have written procedures for all activities related to drug production, assuring the identity, strength, quality, and purity of these products.

Furthermore, any deviation from the documents needs to be recorded and justified.

40 CFR Part 160

In 40 CFR Part 160, we find the GLP for laboratories conducting studies for pesticide products, such as insecticides, fungicides, and rodenticides.

Concerning the laboratory document control, this part is very similar to Part 58.

Clinical Laboratory Improvement Amendments (CLIA)

The CLIA is adjustments made to the Public Health Services Act by the US Congress over time. The goal is to ensure the accuracy and reliability of testing in all laboratories that test human beings.

The specific regulations to comply with CLIA are found in Part 493, as follows.

42 CFR Part 493

Laboratories must comply with 42 CFR Part 493 to be certified to perform testing on human specimens.

You will need to keep documents and records for two to ten years regarding all activities performed. Including, but not limited to:

• Certificate of compliance
• Certificate of accreditation
• Sample control procedures
• Quality control
• Quality assurance
• Proficiency testing
• Personnel files
• Equipment files

Of course, all these documents must be reviewed, approved, and signed by the responsible laboratory staff.

When dealing with electronic QMS (eQMS), the signatures can also be done electronically.

And for that, let’s see two more requirements described below.

21 CFR Part 11

The US FDA 21 CFR Part 11 outlines that persons may use electronic records instead of paper records or electronic signatures instead of traditional signatures.

The laboratory needs to use a system that allows for individual use of signatures, using identification code and password, which expires from time to time.

You can learn more about this topic in our guide about 21 CFR Part 11 software requirements.

EU Annex 11

This European regulation amendment, EU Annex 11, is responsible for the guidelines where a computerized system replaces a manual operation.

Regarding signatures, it is close to 21 CFR Part 11.

Moreover, having control of your documents is essential to achieve quality and compliance with all requirements.

As we learned above, a system for document control must include ways to:

• Create, edit and approve documents and records
• Promote training and learning for personnel
• Ensure documents are available to all
• Prevent obsolete documents from being used
• Limit access to confidential documents
• Facilitate document presentation during audits
• Retain documents and records for the specified period

SimplerQMS provides a document control software solution that is already fully in compliance with major regulatory requirements, such as 21 CFR Part 11 and Annex 11 regarding validation and electronic signatures.

With SimplerQMS, you can take full control of your laboratory documents, work more efficiently and make compliance easier.

Laboratory Document Control Best Practices

Now that we know the importance of laboratory document control to quality and compliance – let’s have a look at some of the best practices when dealing with these high-valued documents.

First, every document and record must be written in a straightforward, concise, user-friendly, and accurate manner to ensure anyone can fully understand the information.

Other best practices include:

• Keeping a chronological order of the documents
• Updating documents periodically, if applicable
• Sharing the most current version
• Implementing access levels and change control
• Assuring laboratory staff learned the documents
• Defining roles and responsibilities for the staff
• Making sure essential information is filled in (author, date, time, version, department, signatures)
• Following a workflow to create, edit, review, approve, share, update, and dispose of documents
• Storing documents in an orderly manner
• Retaining files for the proper length of time
• Implementing an electronic laboratory document management system

In the case of clinical and medical laboratories that use paper-based or hybrid document control systems, having these best practices in place is a great way to start improving document control.

The next step to optimize laboratory document control is implementing a digital solution.

Implementing a Laboratory Document Control Software

It is already clear that implementing a paper-based or hybrid laboratory document control system is not an easy task.

Especially using paper, you will need a vast and secure physical space, a lot of organizational skills, and a well-trained team focused on keeping documents in order. And even in the best situations, errors can occur, documents can be lost, and your team may struggle to access the files they need.

Today, the best way to have laboratory document control is through a designed system. Electronic QMS solutions with powerful document controls like SimplerQMS are an efficient, safe, intelligent, and least laborious way to ensure document control is being done correctly.

SimplerQMS provides an intuitive interface with comprehensive features and built-in support for regulatory compliance so that you can handle the requirements regarding document control and quality management.

Utilize the native integration with Microsoft Office and keep using the same program you already know. All documents and records are secure using a cloud platform for storage and readily accessible in one centralized place. You can attribute role-based access levels and implement digital signatures to control your documents fully.

To investigate whether investing in eQMS software with built-in document controls is the best solution for you, we recommend you download our free eQMS Business Case template.

An Excel spreadsheet with all the necessary information and calculations will help you understand the financial impact of investing in quality management software. And PowerPoint slides will give you inspiration for preparing the business case presentation to decision-makers.

Final Thoughts

You will deal with a high volume of data and information when working in a clinical or medical laboratory. It means a high volume of documents, reports, and all sorts of written materials.

Having control of these documents is critical to ensure the quality of work and compliance with national and international standards.

With laboratory document control software such as SimplerQMS, you will be able to manage all documents with an easy and clear mind that all standards and requirements are being met.

If any of this sounds appealing, book a demo and talk to SimplerQMS experts to streamline your document control processes!

The post Laboratory Document Control: A Simple (But Complete) Guide appeared first on SimplerQMS.

Under regulatory standards like ISO 13485 and the FDA 21 CFR Part 820, you are obliged to maintain and control certain documents. In addition, if your company uses an electronic document control solution, FDA 21 CFR Part 11 will highlight the ways and means of handling electronic records and signatures.

As a medical device QMS software provider, having helped medical device companies of all sizes across the globe switch effortlessly from traditional paper-based QMS systems to digital software solutions, we know a thing or two about document control.

In this article, we will delve into the main requirements for a medical device document control system, the problems that companies face with traditional systems, how you can streamline the entire document control process, as well as the benefits you accrue when you invest in a digital document control solution.

But first, let us understand the basics:

• What is Medical Device Document Control?
• Medical Device Document Control Requirements
• The Challenges of Traditional Medical Device Document Control
• How to Streamline and Simplify Your Medical Device Document Control System
• Streamline Document Control at Your Medical Device Organization

What is Medical Device Document Control?

Medical device document control can be defined as the processes and procedures that organizations operating in the medical device industry will systematically apply to guarantee that the documents pertaining to the lifecycle of a medical device product will be created, re-evaluated, circulated, and disposed of in a provable and organized manner.

Such document control is at the crux of your medical device quality management system. It is also mandated under international regulatory standards, including FDA 21 CFR Part 820, ISO 13485:2016, EU MDR, and FDA 21 CFR Part 11. More on this in a bit.

Let us take the example of the AI-enhanced remote ultrasound system. It is but natural that you will put your best foot forward! Your company will ensure that every minute detail is looked into, as there will be a lot of scrutiny from space agencies, regulatory agencies, the public, and your competitors. One of the best ways to ensure that your product is accepted is with efficient documentation and document control.

Difference Between Document Control and Document Management

The main difference between document control and document management is that document management indicates the systems and procedures that your company will put in place to maintain and manage documentation pertaining to the lifecycle of a medical device product.

This means the “how’s and why’s” of storage, tracking, updating, and sharing of such documents.

Document control is the practices in place to ensure the creation, review, distribution, and disposal of documents of the lifecycle of a product methodically.

For example, during the conceptualization and manufacture of the enhanced remote ultrasound system, you will be generating tonnes of documents. With a document management system, you will store, track, update, and share these documents with relevant personnel and stakeholders. How you create, distribute, and dispose of these documents will fall under the purview of document control.

You can streamline your document control processes with our medical device document control software. It helps you manage and control documents, control changes, and approve documents electronically. Furthermore, the SimplerQMS document control solution is part of the quality management suite, which is a complete end-to-end quality management solution for medical device companies.

Medical Device Document Control Requirements

Effective document control is at the crux of all life sciences companies, including medical device manufacturers. Several international guidelines govern it.

They are as follows:

• FDA 21 CFR Part 820.40
• ISO 13485: 2016
• EU MDR
• FDA 21 CFR Part 11

FDA 21 CFR Part 820.40

FDA 21 CFR Part 820 is the standard from the US Government’s Food and Drugs Administration (FDA) that applies to current good manufacturing practice requirements for all finished medical devices that are intended for human use in the United States.

When we consider document control, we need to refer specifically to section 820.40 of the FDA 21 CFR Part 820, which states the following.

“Each manufacturer shall establish and maintain procedures to control all documents that are required by this part. The procedures shall provide for the following:

(a) Document approval and distribution. Each manufacturer shall designate an individual(s) to review for adequacy and approve before issuance all documents established to meet the requirements of this part. The approval, including the date and signature of the individual(s) approving the document, shall be documented. Documents established to meet the requirements of this part shall be available at all locations for which they are designated, used, or otherwise necessary, and all obsolete documents shall be promptly removed from all points of use or otherwise prevented from unintended use.

(b) Document changes. Changes to documents shall be reviewed and approved by an individual(s) in the same function or organization that performed the original review and approval, unless specifically designated otherwise. Approved changes shall be communicated to the appropriate personnel in a timely manner. Each manufacturer shall maintain records of changes to documents. Change records shall include a description of the change, identification of the affected documents, the signature of the approving individual(s), the approval date, and when the change becomes effective.”

Succinctly, section 820.40 states that medical device companies selling their products in the US market should have protocols and procedures for the control of all pertinent documents as highlighted in the FDA’s Quality Systems Regulations (QSR).

ISO 13485:2016 Section 4.2.4

The International Organization for Standardization (ISO) guidelines provide medical device companies with the standards for their Quality Management Systems.

Section 4.2.4 (Control of Documentation) of ISO 13485:2016 specifically states that:

“Documents required by the quality management system shall be controlled.”

In this section, the magnitude of document control is emphasized for the entirety of a medical device’s lifecycle.

ISO 13485:2016 Section 4.1.6

Furthermore, section 4.1.6 of ISO 13485:2016 highlights a company’s requirements for computer system validation in the following way.

“The organization shall document procedures for the validation of the application of computer software used in the quality management system. Such software applications shall be validated prior to initial use and, as appropriate, after changes to such software or its application.”

This becomes important when we consider the use of an electronic document management system or electronic QMS.

EU MDR

The Medical Device Regulation of the European Union (EU MDR) which came into full effect on the 26th of May, 2021 contains many relevant points when it comes to document control.

The emphasis is on the complete lifecycle of a medical device, including:

• Periodic safety update reports (PSUR)
• Document storage retention
• Post-market surveillance systems

Periodic safety update reports (PSURs) are pharmacovigilance documents that your company will submit to the regulatory agency regularly to disclose the worldwide safety experience of a product.

Post-market surveillance reports are for medical devices that are already on the market. Your company will collect and evaluate the experiences gained from such medical devices and determine if you need to take any further action.

Recommended Reading

• Post-Market Surveillance (PMS) for Medical Devices
• EU MDR Quality Management System [Role of an eQMS]

Summary of Key Requirements for Document Control in Medical Device Companies

International regulations and standards, including FDA 21 CFR Part 820, ISO 13485:2016, and EU MDR have several commonalities that are listed below:

• Document control protocols: Your company requires a dependable and standardized policy for the management of all relevant documents.
• An up-to-date version of the document: The documents in circulation and those present at applicable locations in your company must be available only in the latest up-to-date versions.
• Rules for document control approvals: (1) All document control approvals in your company must compulsorily include the signatures of the person(s) approving the said document, with the date on which the approval was given. (2) Such approved changes in documents need to be communicated with the relevant personnel in all concerned departments. (3) Any changes in a document must be reviewed and approved by the person(s) who was initially involved in the original review and approval.
• Evaluation of procedures: The senior management in your company will identify the most appropriate person(s) who will evaluate all protocols concerning pertinent documents.

FDA 21 CFR Part 11

The US FDA describes 21 CFR Part 11 in the following way:

“The regulations in this part set forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.”

FDA 21 Part 11 applies to your company if you are using any type of electronic document management software. Even if you have a paper-based documentation system, but use email for sending and receiving documents, scan documents electronically, and/or have a server for storing electronic versions of documents, you will have to be compliant with this FDA regulation.

Essential FDA 21 CFR Part 11 Software Requirements

When your medical device company has transitioned into a 21 CFR Part 11 compliant document management system, the following requirements become applicable to you:

• System validation: Your company should authenticate the system software regularly. This is needed to ensure that all components of the system are working as projected.
• Operational controls: The system in your company will utilize a phase-gate process for analyzing and controlling all quality procedures.
• Record generation: The system should effectively and efficiently generate exact copies of records and documents that concern your company’s Quality Management System. In addition to electronic copies it should be able to generate physical printouts, whenever required.
• Audit trails: The audit history file of the system should be able to store all new documents, modified documents, and deleted documents. The audit history file should not be modifiable. These features allow your company to have a secure and trustworthy audit trail of all records and documents generated by the company.
• Training: Any person who needs to access the document control solution must first be properly trained. They should have the requisite education and experience to handle assigned duties.
• Electronic signatures: An important feature of an electronic document control system is the ability to generate electronic signatures of the person(s) reviewing and approving documents. These signatures will also contain the name(s) of the signatory, ownership, date, and time.
• Security controls: You will allow only relevant personnel to access the system with the help of unique login usernames and passwords.

Check out our article on the FDA 21 CFR Part 11 software requirements to learn more about this topic.

You can simplify compliance with document control requirements by investing in a fully validated medical device QMS solution, like SimplerQMS.

SimplerQMS has been purposely built to help medical device companies work more efficiently and meet stringent regulatory requirements such as FDA 21 CFR Part 820, ISO 13485:2016, EU MDR, and FDA 21 CFR Part 11.

We provide QMS software with built-in document controls for medical device companies, which include features like automatic version, revision control, FDA 21 CFR Part 11 compliant digital signatures, and time-stamped audit trails for all document changes. In addition, a centralized, cloud-hosted repository assures both compliance and audit readiness.

The Challenges of Traditional Medical Device Document Control

When medical device companies use traditional paper-based legacy systems, and/or ad-hoc document control systems, or hybrid document control systems, they will face many challenges. This applies equally well to both small and large organizations.

These challenges can be categorized as presented below.

Document Version Control Confusion

With paper-based document control systems, even the best-organized companies can have major issues with document version control.

How will you ensure that all departments within the organization have only the most current versions of relevant documents?

It becomes cumbersome and a waste of precious resources tracking down document activity and keeping track of specific changes in every document.

Imagine this scenario – the manufacturing unit in a medical device company is relying on a document related to third-party selection that is over two years old. They are not aware that this document was superseded by a newer version six months back.

Time Inefficiency

A major challenge that companies using paper-based document control systems face is the waste of valuable time.

• You are likely to put in much effort to:
• Route documents to relevant departments
• Have discussions and make changes
• Get authorized staff to approve and sign these documents
• Hunt for misplaced documents and records
• Etc.

For example, the FDA/ISO auditors have come to audit a medical device company. They ask for certain documents to be submitted during the audit. These documents need to be retrieved from the specific department. This can take the time that should have been utilized more meaningfully.

Ineffective Document Collaboration

Anyone who continues to use physical paper-based systems will know that it is very difficult to make multiple edits and then circulate the latest version of a document to their designated areas.

It takes a lot of time and effort to ensure that everyone has received the same version. And there is also no guarantee that all relevant personnel will receive the updated document on time.

Lack of Security

When documents are manually filed in a retrieval system, the person(s) handling this task may file them under the wrong name or even lose the document.

Also, how will the company ensure that sensitive documents are secured?

Is it not possible for a disgruntled employee or a competitor to break into a physical retrieval system and gain access to proprietary information?

Lack of Accessibility

Accessibility issues are plenty with paper-based document systems.

For example, a key senior staff member is on sick leave when their signature is urgently required on a crucial document.

How will this document be validated in the absence of this person?

Ineffective Communication

Inevitably with traditional documentation systems communications is not efficient.

You need to communicate with multiple stakeholders during the entirety of a medical device lifecycle, including but not limited to:

• Internal departments
• Branches of the company in different locations
• Third-party vendors
• Regulatory agencies
• Product end-users
• And others

Inefficient communication can result in delayed supplies, recalls, and even more serious, and warning letters.

Lack of Oversight

When a company is reliant on paper-based systems, unintentional failures can creep in because of a lack of proper oversight.

Documents may remain unsigned, documents may be stored in multiple locations, and you may be too reliant on multiple people and different tools such as spreadsheets and Google docs.

All of these can result in inaccuracies creeping in.

Difficulty Maintaining Regulatory Compliance

When a company has a paper-based system in place, they are reliant on its personnel to be up-to-date with the latest regulatory standards and guidelines.

What if this person(s) is still unaware of the recent EU MDR guidelines?

And the list of such issues goes on…

Do you find yourself facing any of these challenges?

Well, rather than trying to work around these inefficiencies, medical device organizations are now turning to software solutions for a better way to manage their documents.

The problems with security, document versions, accessibility, editing, and manual processes can all be remedied with the right software solution, like SimplerQMS. At the same time, maintaining compliance with stringent regulatory requirements is made easier.

How to Streamline and Simplify Your Medical Device Document Control System

Documentation and document control are of the utmost essence for a company that deals with products that affect human lives. Having considered what document control is, and the common challenges of traditional paper-based systems, let us check on some of the best practices for streamlining and simplifying medical device document control.

Employ a Document Controller

A document controller, or document control specialist, is a technically proficient person who is in charge of all document control activities in the organization.

Depending on the size of the company, you may employ more than one document controller. Since document control needs technical expertise in several areas, it is prudent to have more than one document control specialist, especially in larger companies.

Have Procedures and Protocols in Place for Document Control

The organization should have a Quality manual for all document control procedures.

The Quality Manual will emphasize a standardized and controlled manner to organize documents and data.

The key aspects of the Quality Manual include:

• Creating documents
• Review and approval
• Revisions to documents
• Publishing documents
• Disposal or archiving of old documents

Employ Standard Naming Conventions for All Your Documents

A standard file naming convention provides your organization with the proper structure for listing all files. This will help describe the contents of each file and their relationship to other files.

Good practices for naming files are:

• Consistent names for files
• Short yet descriptive file names (<25 characters)
• Avoidance of special characters and spaces in the file name
• Inclusion of the version number

An example of a standard file naming convention is given below:

• A numbering system for large files/folders
• The project Lead’s Initials/last name-first name
• The file creator’s initials/last name-first name
• Project title or a suitable acronym for common file types (for example- BD= business documentation)
• The date on which the file was generated or created (either DD/MM/YY or YY/MM/DD depending on which side of the Atlantic Ocean you are located)
• The version number of the file

Your organization can consider following a similar convention. This will go a long way towards streamlining and simplifying your document control procedures.

Leverage the Use of Reusable Document Forms and Templates

Your staff should not waste their time redeveloping document forms and templates for every new project. When you have reusable forms and templates that have withstood the test of time, it makes life much easier for everyone.

Some examples of reusable document forms and templates include:

• Non-conformance Report (NCR) templates
• Corrective Action and Preventive Action (CAPA) form templates
• Change Control forms
• Complaints and Calibration forms
• Training Attestation forms

Utilize Cloud Storage

With cloud storage, you will be storing your files on cloud servers.

Even if a server crashes, your precious data is accessible from other locations, thanks to data backup and recovery services.

For example, in SimplerQMS data backups are executed every 15 minutes, stored in multiple geographical locations, and monitored by professionals 24/7. This ensures that your data is always safe and sound, no matter what happens.

Establish a Single Source of Truth

The documents that your company generates throughout the lifecycle of a medical device product highlight the authenticity of the processes and protocols. These documents will assure your stakeholders that your products are of high quality, safe, and efficacious for human use.

Essentially it means that these documents are a single source of truth. So, document control is imperative for this purpose.

By centralizing all documents in a single repository, ensuring that only the latest version of documents is in use, the history of every document is traceable, and streamlining communication and collaboration between departments and stakeholders, you will have a single source of truth.

Make Continuous Improvements

When your company is expanding or becoming more established, you will need to make improvements to your document control system. The restructuring of the document control system to suit your current needs can be intimidating.

But, by splitting each step into smaller manageable phases, the work becomes easier.

Your organization can start by ensuring that copies of all documents are stored in a secure centralized repository. Make certain that you have proper filing systems for the latest versions vis-à-vis obsolete versions of these documents. Also, schedule reoccurring document review tasks and make it a point to review and update the documents on a regular basis.

Integrate With eQMS and Automate the Core QMS Processes

The steps mentioned so far can all be implemented manually.

But, for document control to work fully and most efficiently, you can consider automating the completed documentation processes and integrating them using an eQMS software solution like SimplerQMS.

By connecting your document control system with an entire QMS, you will be able to automate and streamline core QMS processes. This will enable real-time collaboration between departments and stakeholders, give you full traceability, timely reminders, easier audits and regulatory compliance management, and better management of all your documents, using one central system.

Streamline Document Control at Your Medical Device Organization

Traditional medical device document control using paper-based systems or a mix of paper and electronic files has its inherent challenges. These include the utilization of precious resources including time for such manual processes and the possibility of errors creeping in.

All of these can expose your company to compliance issues with regulatory agencies. This can further compound into product recalls.

SimplerQMS provides you with medical device document control software that is a part of the quality management suite, providing a complete closed-loop quality management solution.

Features like automatic version control, revision control, electronic signature, full audit trails, automated document workflows, and others make it easier for you to manage documents while maintaining compliance with ISO 13485:2016, EU MDR, FDA 21 CFR Part 820, and FDA 21 CFR Part 11.

Cloud deployment also ensures that your data is always accessible, backed up, and secure.

Streamline Your Document Control Processes With Medical Device Document Control Software

Final Thoughts

Document control for a medical device company signifies the strategies and methods that are followed for the management of all the documents generated during the lifecycle of a medical device product.

With document control, you are ensuring that documents are created, reviewed, distributed, archived, and/or disposed of in a verifiable and organized manner.

Traditional document control systems are plagued by many deficiencies, including issues of security, storage, document versions, resource management, accessibility, and compliance.

When you invest in a medical device eQMS solution such as SimplerQMS, your company will streamline and automate documentation processes, eliminate the problems of paper-based systems, and be better prepared for audits and inspections.

If you are keen on streamlining and simplifying your document management processes, book a personalized demo and talk to one of our quality solution experts to see how SimplerQMS can help you in your document control journey.

The post Medical Device Document Control appeared first on SimplerQMS.

Pharmaceutical document management can be defined as a repository of all the documents that your organization (be it pharmaceutical, biotechnology, or clinical research organization) will be generating, handling, and maintaining during the entirety of a drug development process, be it a new drug, diet, or a new treatment.

It is the foundation for your organization’s pharmaceutical quality management system. This also means that you have a legal obligation to keep track of all documents related to the production and distribution of the products in compliance with certain documentation standards. This also includes the FDA 21 CFR Part 11 in case you use an electronic system for managing documents.

The fact that we have built an all-in-one QMS software for life science organizations and have helped pharmaceutical companies of all sizes, and from all parts of the globe, to smoothly transition from paper-based QMS systems to digital QMS solutions means that we know a thing or two about pharmaceutical document management.

In this article, we will discuss the main requirements for pharmaceutical document management, the advantages of effective documentation processes, and some of the benefits of digital document management solutions.

But first, let’s start with the basics:

• What is Pharmaceutical Document Management?
• What Are the Benefits of Effective Pharmaceutical Document Management?
• What Are the Regulatory Requirements for Pharmaceutical Document Management?
• Things to Consider When Implementing Effective Pharmaceutical Document Control
• Choose the Right Pharmaceutical Document Management Software

What is Pharmaceutical Document Management?

Pharmaceutical document management can be defined as a system that captures, stores, and tracks all the documents related to the development, production, and distribution of pharmaceutical products.

It can be considered one of the most critical components of your organization’s pharmaceutical quality management system.

When your organization is involved in the process of developing a new treatment, a new drug, or a diet, you will be generating a large number of documents. These documents need to be safely and efficiently maintained for the purposes of auditing and to show to your internal and external stakeholders that the product being developed is both safe and efficacious.

Recommended Reading: What is Document Control in Life Sciences?

What Are the Benefits of Effective Pharmaceutical Document Management?

The benefits of effective pharmaceutical document management are many and varied, but can be summarized in the following 5 benefits:

• Compliance: With effective pharmaceutical document management, your organization will be up-to-date with all regulatory requirements. This will ensure better audit readiness, which in turn will lead to fewer compliance issues. There would be almost no time wasted when you submit your documents, for example, an Investigational New Drug Application.
• Efficiency: Your organization will be generating thousands of documents throughout the lifecycle of a product. When you manage your documents effectively, you will not lose documents, all details will be traceable, and it will be easier to find the documents you need when you need them. You will not lose valuable person-hours because the human error will be reduced. If your company is investigating several drugs at the same time, efficient pharmaceutical document management practices will ensure that there is no mix-up of the documents – documents about one product will be completely separate from the others.
• Single source of truth: All documents will be available in one place. This will ensure that different departments within your organization are working from the same set of latest documents. This will avoid confusion and discrepancies, and everyone will be on the same page, figuratively speaking.
• Security: Effective pharmaceutical document management will ensure that all documents are safe and secure. Only authorized personnel will be able to access pertinent documents.
• Faster time to market:  The effective pharmaceutical document control system in your organization will ensure that precious time is not wasted, as a result, you will be able to get your products to market faster.

All these benefits can be even more effectively realized by implementing a cloud-based document management solution that provides a centralized document repository with complete security and control, like SimplerQMS.

SimplerQMS provides pharmaceutical eQMS software with robust document control capabilities, designed to help you manage your documents more effectively and efficiently while ensuring compliance with all the applicable regulatory requirements.

It provides features such as document version control, revision control, document workflows for document authoring, review, approvals, archiving, the FDA 21 CFR Part 11 compliant electronic signatures, time-stamped audit trails, and more.

What Are the Regulatory Requirements for Pharmaceutical Document Management?

Several regulatory guidelines describe how pharmaceutical organizations should go about managing their documents. The main ones are the following.

International Council for Harmonisation (ICH) E6

The introductory section of essential Documents for the conduct of a clinical trial as per ICH E6 (R2) Good clinical practices states that:

“Documents are those documents which individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. These documents serve to demonstrate the compliance of the investigator, sponsor and monitor with the standards of Good Clinical Practice and with all applicable regulatory requirements. Essential Documents also serve several other important purposes. Filing essential documents at the investigator/institution and sponsor sites in a timely manner can greatly assist in the successful management of a trial by the investigator, sponsor and monitor. These documents are also the ones which are usually audited by the sponsor’s independent audit function and inspected by the regulatory authority(ies) as part of the process to confirm the validity of the trial conduct and the integrity of data collected.”

ICH E6 states that your organization will need to maintain essential documents that will permit the regulatory agencies to evaluate the conduct of the clinical trial, and the quality of the data produced.

These documents need to be filed in a timely manner for the successful management of the clinical trial.

Current Good Manufacturing Practice Regulations

The Current Good Manufacturing Practice (cGMP) regulations are enforced by the FDA.

Amongst other things, it ensures that your pharmaceutical organization will establish strong quality management systems (including documentation) that will ensure that medications are manufactured using adequate controls.

To learn more about cGMP, you can read our article explaining what are Current Good Manufacturing Practices (cGMP).

FDA 21 CFR Part 58

The GLPs that your organization must have for the conduct of nonclinical laboratory studies that will support research or marketing of human and animal drugs, medical devices, and others are enshrined in the FDA 21 CFR Part 58.

FDA 21 CFR Part 210

FDA 21 CFR Part 210 states:

“The regulations set forth in this part and in parts 211, 225, and 226 of this chapter contain the minimum current good manufacturing practice for methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packing, or holding of a drug to assure that such drug meets the requirements of the act as to safety, and has the identity and strength and meets the quality and purity characteristics that it purports or is represented to possess.”

As described above, these requirements will ensure that your organization will, at the minimum, will practice cGMPs for the manufacture, processing, packaging, and holding of drugs.

FDA 21 CFR Part 312

As per the FDA CFR Part 312:

“This part contains procedures and requirements governing the use of investigational new drugs, including procedures and requirements for the submission to, and review by, the Food and Drug Administration of investigational new drug applications (IND’s). An investigational new drug for which an IND is in effect in accordance with this part is exempt from the premarketing approval requirements that are otherwise applicable and may be shipped lawfully for the purpose of conducting clinical investigations of that drug.”

FDA 21 CFR Part 314

As per the FDA CFR Part 314:

“This part sets forth procedures and requirements for the submission to, and the review by, the Food and Drug Administration of applications and abbreviated applications to market a new drug under section 505 of the Federal Food, Drug, and Cosmetic Act, as well as amendments, supplements, and postmarketing reports to them.”

Both the FDA 21 CFR Parts 312 & 314 govern the use of investigational new drugs.

When we look at the regulatory requirements for pharmaceutical document management, we see that there is overlap across many regulations and standards.

However, the main requirements can be summarized as follows:

• Document control procedures: A dependable and standardized way in which the organization will manage all documents, from creation to obsolescence.
• Document control requirements: The need to maintain and regularly update essential documents that will be submitted to regulatory agencies.
• Filing of documents in a timely manner: This will ensure the successful management of the clinical trials.

The above is a high-level overview of the regulatory requirements for pharmaceutical manufacturers regarding documentation. To get a professional and comprehensive understanding of your specific needs, it is best to choose a knowledgeable pharmaceutical consultant.

FDA 21 CFR Part 11

As per the FDA 21 CFR Part 11:

“Part 11 applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any records requirements set forth in Agency regulations. Part 11 also applies to electronic records submitted to the Agency under the Federal Food, Drug, and Cosmetic Act (the Act) and the Public Health Service Act (the PHS Act).”

21 CFR Part 11 is important when your organization is maintaining documents using an electronic system. It will also apply when you are submitting these documents electronically to the US FDA.

A crucial prerequisite of 21 CFR Part 11 is the validation of the electronic system that you have for maintaining accuracy, trustworthiness, and uniformity of data.

To ensure compliance with 21 CFR Part 11, you must ensure that your electronic system meets requirements regarding:

• Validation
• Record generation
• Audit trails
• Operational controls
• Electronic signatures
• Security controls
• And more

To learn more about 21 CFR Part 11 and how to ensure compliance if you use an electronic document management system, read our article on the FDA 21 CFR Part 11 software requirements.

SimplerQMS was purposefully built for life science companies with complaince in mind. The system helps companies in the pharmaceutical industry meet international regulatory requirements for document control, including Current Good Manufacturing Practices (cGMP), Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and others.

With SimplerQMS you are assured of automatic version and revision control of all your documents, as well as a complete audit trail of all the activities related to each document. The software also supports 21 CFR Part 11 compliant electronic signatures, providing a complete solution for your document management needs.

Things to Consider When Implementing Effective Pharmaceutical Document Control

The following tips will help you implement an efficient pharmaceutical document management system in your organization.

Evaluate the Current Document Management System

Currently, you may have written policies for document management in your organization. It is possible that these policies may be incomplete or lacking in one or more details.

You need to look out for the following:

• Out-of-date versions of guidelines: For example, your organization is relying on FDA 21 CFR Part 312 dated 28-02-2019, whereas the latest version is dated 07-07-2022.
• Incomplete documents: If you have continued with the traditional paper-based manual system of documentation, and only recently transitioned to an electronic QMS, you may not have incorporated FDA 21 CFR Part 11 guidelines in your document management system.
• Irrelevant documents: Some areas of your organization such as billing and finance do not come within the scope of pharmaceutical document management. Yet, your current document management system may contain these.

A thorough analysis of your current document management system will help you understand the need to update, streamline, or remove irrelevant documents. This restructuring will save your organization both time and money in the long run.

Implement an Automated Pharmaceutical Document Management Software

When you evaluated your current pharmaceutical document management system, you may have come across one or more lacunae such as the following:

• Out-of-date documents
• Absence of current guidelines
• Presence of irrelevant documents
• Etc.

The implementation of automated pharmaceutical document management software could help you ensure that this does not happen in the future.

The system will help you in the following ways:

• Automate the process of document management: The software will automate the various tasks involved in document management such as the creation, routing, review, approval, and archiving of documents.
• Ensure timely updates of documents: The software will ensure that all your documents are always up-to-date. It will also send alerts to the concerned personnel whenever a document is due for revision.
• Provide easy access to documents: The software will provide easy and quick access to documents from any location and at any time.
• Facilitate collaboration: The software will enable easy collaboration between different departments and personnel within your organization.
• Provide access control: The software will provide different levels of access to documents based on the role of the personnel. For example, only people involved in the manufacturing process will have access to the SOPs for manufacturing.
• Ensure security: The software will ensure that all your documents are secure and can only be accessed by authorized personnel.
• Improve compliance: The software will help you improve compliance with international regulatory guidelines such as FDA 21 CFR Part 11, cGMP, GCP, GLP, and others.

Plus, many automated pharmaceutical document management systems allow you to easily integrate with your existing enterprise solutions like Customer Relationship Management (CRM), an Enterprise Resource Planning (ERP) solution, and others.

Utilize Document Forms and Templates

It is a well-known fact that pharmaceutical companies take years of research to get new drugs, medications, etc. into the market. This involves the generation of tons of documents.

When you use pre-approved document forms and templates, your scientists and research staff will be able to focus on their work and not waste time on documentation. Additionally, you will be able to standardize your documents and reduce the risk of errors.

Here are some of the examples of document forms and templates that you can use in your organization:

• Preclinical phase templates and forms could include participant recruitment forms, informed consent forms, or Memorandum of Understanding (MOU) forms.
• Templates from the clinical phase would typically include investigators’ brochures, clinical study protocols, and case record forms.
• Post-marketing phase templates are those that capture relevant information on adverse events (e.g. deviations, complaints, and corrective and preventive actions) they include but are not limited to, product complaint forms, non-conformance report templates or deviation forms, and CAPA form templates.

SimplerQMS allows you to create and manage document forms and templates with ease. Then create documents using those forms and templates with just a few clicks, and edit them in Microsoft Word, Excel, or PowerPoint.

You can import your own forms and templates or use our pre-approved forms and templates.

Employ a Document Controller

You may also consider hiring a document controller/document control specialist.

This person(s) will be responsible for the complete document control procedures in your organization. Document control is the practice that you follow to create, review, distribute, and dispose of documents in a provable and structured manner.

The document controller will integrate and promote quality into all aspects of documentation in your pharmaceutical organization. This person(s) will do document control, document archival, and updating of all documents independently or with minimal guidance.

You may consider employing a document controller when your organization is planning to expand to new markets or when you are planning to transition from your current document management system to an automated QMS platform.

Establish a Single Source of Truth

The documents that are generated and shared with stakeholders, including regulatory agencies, are the single source of truth about the processes, protocols, and procedures that you are following during the manufacture of products.

An effective pharmaceutical document management system will highlight this truth.

The core benefits of having a single source of truth are:

• Centralized repository of all documents: All your organization’s documents will be stored in a central repository. This will make it easy for personnel to find and use the documents.
• Improved version control: Maintain different versions of documents and track the changes made to them. This will help you ensure that only the latest version of a document is in use.
• Improved communication and collaboration: More streamlined communication and collaboration between different departments and personnel will lead to better decision-making.
• Enhanced traceability: Easily trace the history of a document and track who made what changes to it. This will be helpful during audits.

With the SimplerQMS software solution, you are ensured of full, time-stamped audit trails, a centralized file repository, and broad QMS process support. You can learn more about our pharmaceutical document control software on our website or schedule a tailored demo.

Choose the Right Pharmaceutical Document Management Software

Nowadays, organizations that continue to maintain the traditional manual pharmaceutical documentation systems are exposed to a plethora of challenges.

These include, but are not limited to, time and labor-intensive, security issues, storage problems, error-prone documentation, compliance issues, and in the current scenario, environmental issues with a ton of papers, inks, and so on.

When you implement the SimplerQMS software solution, you are provided with pharmaceutical document management software that has been designed specifically for organizations such as yours. You get a secure, cloud-based, streamlined document management process that helps ensure regulatory compliance with international regulatory requirements such as GCP, cGMP, GLP, FDA 21 CFR Part 11, and others.

The SimplerQMS software solution will automate the steps of creation, reviewing, approval, and distribution of all documents.

Some of the key features include version and revision control, electronic signatures, controlled printing, full audit trails, and a secure centralized document repository.

These features allow your organization to efficiently manage all your documents and gain better visibility into the status of your Quality Management System.

As a result, you will save precious time and money, ensure compliance, and access the market quicker than your competitors.

Final Thoughts

When you are in the business of manufacturing drugs that affect the lives of people, you must ensure that your pharmaceutical documentation management is streamlined, efficient, and up-to-date.

Your stakeholders, including the regulatory agencies and the end-users, rely on the veracity of these documents. Your brand name is reliant on these documents that form the crux of your quality management system.

It is not easy to have a manual paper-based documentation system and not expect issues to crop up. When you have an efficient pharmaceutical document management solution, like SimplerQMS, you are assured of automated workflows, compliance with applicable regulatory requirements, and the proficient management of all your documents.

If you are keen on streamlining your pharmaceutical document management processes – book a personalized demo and talk to our quality solution expert to see how SimplerQMS can help you!

The post Effective Pharmaceutical Document Management appeared first on SimplerQMS.

Documentation is crucial to prove the safety and effectiveness of your organization’s products such as medical devices and pharmaceuticals. Documentation will prove the dependability, reproducibility, and repeatability of the processes. With documentation, you are efficiently communicating what has to be done, when it has to be done, and how it has to be done.

These are the topics we will cover:

• Document Control Definition
• Document Control Requirements
• Document Control Procedures
• Importance of Document Control
• How to Achieve Effective Document Control
• What Is a Document Control Software
• Document Control Automation
• Frequently Asked Questions on Document Control

Document Control Definition

Document control can be defined as a series of practices that ensure that documents are created, reviewed, distributed, and disposed of in an organized and verifiable manner.

You might also use the term “document management”. While these terms are closely related, they are not interchangeable.

Document management indicates the systems and processes your organization has put in place for maintaining and managing documentation. It is the storage, location, tracking, updating, and sharing of documents.

Let us look at some examples from the life sciences industry to get a better understanding of document control.

Recommended Reading

• A Guide to Effective Pharmaceutical Document Management
• Medical Device Document Control: What It Is & How to Simplify It
• Laboratory Document Control: A Simple (But Complete) Guide

Document Control Requirements

Since effective document control is the mainstay of the life sciences industry, several international guidelines and standards govern it.

They include FDA 21 CFR Part 820.40, ISO 13485:2016, the European Union’s medical device regulation (EU MDR), FDA 21 CFR Part 11, and GxP.

FDA 21 CFR Part 820.40: This standard from the US Food and Drugs Administration refers to document control for medical devices companies that are manufacturing or selling products in the US market. Such companies must institute and maintain procedures for the control of all relevant and related documents that are emphasized in the FDA’s Quality System Regulations (QSR).

ISO 13485:2016 Section 4.2.4 (Control of Documentation): This International Organization for Standardization’s guideline provides the standards for medical devices quality management systems (QMS). The particular section highlights the importance of document control throughout the lifecycle of a medical device.

Furthermore, ISO13485:2016 also contains the requirement for Computer System Validation, (Section 4.1.6, General requirements) which is relevant for organizations that use computer software, such as an eQMS or Document Management System to manage their documents.

You should keep in mind that both the above-mentioned standards have substantial commonalities. So, as your organization starts complying with one standard, you will also be preparing for the other standard.

Recommended Reading: Quality Management System Documentation

Key Features for Control of Documents as per ISO 13485:2016 and FDA 21 CFR Part 820

• The organization must identify the most suitable person(s) for evaluation of all procedures concerning relevant documents
• All document control approvals must include signatures of approvers and the date
• All applicable points of use must have the up-to-date version of the document
• Changes, if required, must be reviewed and approved by the same person(s) who were involved in the original review and approval
• Approved changes in documents must be communicated to all relevant users

EU MDR: The latest medical device regulation applicable to the European Union has many points concerning document control. There is an emphasis on the lifecycle of the product in totality. This includes post-market surveillance, which is the set of activities that your organization will do to collect and evaluate the capabilities gained from your medical device that is already in the market and to identify if any further action needs to be taken.

FDA 21 CFR Part 11: Electronic record systems and signatures are probably part and parcel of your organization, and you will have to comply with this FDA standard.

Even if you are wholly paper-based, but still send documents via email, you will have to comply with the US FDA Code of Federal Regulations (CFR) Part 11, Title 21, which states that organizations that use one or other form of electronic record must:

“secure computer-generated, time-stamped audit trails to independently record the date and time of operator entries, and actions that create, modify, or delete electronic records.”

Furthermore, FDA 21 CFR Part 11 also has specific requirements for areas such as Validation, Record Generation, Audit Trails, Operational Controls, and Security Controls.

GxP: This is a collection of quality regulations and guidelines to ensure that products manufactured by the life sciences industry are safe, appropriate for their envisioned use, and abide by all quality practices during their manufacture, control, storage, and supply.

GxP is an acronym for Good (x-variable depending on application- for example, C: Clinical; L: Laboratory; M: Manufacturing; S: Storage; R: Review….) Practice.

The US FDA established GxP for ensuring that pharmaceutical, biotechnology, and medical devices companies conform to the following:

• Accountability – ability to pinpoint the person(s) responsible for the processes and procedures
• Traceability – ability to trace all processes from procurement of raw materials through their development history as a medical device/drug
• Data integrity – ability to rely on the data that is generated

Document Control Procedures

With document control, your organization will manage all documents throughout their lifecycle. It means that it is a dependable, standardized, and organized way of organizing documents, data, and information.

So, you will have a set of procedures for document control and a person(s) who will be responsible for document control. The content of these procedures is dependent on if you are using an electronic system for tasks such as numbering, versioning, and archiving.

Therefore, ask your eQMS vendor to supply a document control procedure, which is aligned with the relevant regulations as it will save you time.

The key steps in the document control procedure are:

1. Creation of the document
2. Review and approval
3. Revisions
4. Publishing
5. Obsoleting/Disposal

1. Creation of the Document

Your organization will determine the person(s)/departments responsible for creating documents and how these documents are to be created. You will also include the details for formatting the document, it’s naming, version history, and other technical details.

2. Review and Approval of the Document

The document control procedure in your organization will also give a detailed explanation of how the prepared document must be reviewed and who are the responsible persons to approve it. Also, how the approvals and modifications should be recorded will be highlighted in the document control procedure. You should be aware that all documents must be reviewed for accuracy before publishing.

3. Revisions to the Document

Please note that even after documents are approved and finalized, they may need changes in the future. Once again, your document control procedure will highlight the process for revising documents.

The emphasis here is on who has the authority to initiate or request revisions, and who will do the actual revisions. The procedure will also define the methodology for identifying a document according to its revision. Only the current and approved document must be published and the older versions must be obsoleted.

4. Publishing the Document

Once you have finalized and approved a document, the next step is to publish it. Your organization’s document control procedure will define the parameters to be followed for publishing a document and the persons authorized to access it. Also, the security restrictions on a published document will need to be well-defined.

5. Obsoleting the Document

This is a crucial step in the lifecycle of a document.

Older versions of a document, as determined by date or version history, are removed from accessibility.

Importance of Document Control

Once your organization has perfected the process of document control, you will leverage multiple benefits.

1. Efficiency

Your life science company will have multiple documents with numerous applications at several locations. With document control, you will be able to organize and track these documents and ensure that only relevant documents are placed in the correct locations.

2. Consistency

With efficient document control, you are spared a lot of trouble and headaches!

All your employees will be working from the same relevant documents and standards.

3. Quality

The most up-to-date version of all documents must be published and older versions obsoleted.

4. Compliance

Your organization will have to comply with all relevant national and international standards/guidelines that were highlighted in a previous section. For this purpose, you must be able to produce the relevant documents on demand. There cannot be excuses about lost documents, irrelevant documents, and so on.

5. Security

Let us take the hypothetical scenario of a disgruntled employee in a key department. The person may access sensitive documents and send them out via email or carry the information on an electronic device.

Also, we should be aware of external hackers. You can prevent this from happening by establishing security protocols in your document control system so that there is no unauthorized access to sensitive information.

6. Accessibility

With good document control, your organization will ensure that every single document and all versions are readily and easily accessible.

7. Enhanced Responsiveness

When organizations understand the need for good document control and initiate steps to achieve it, they become proactive.

They can stay a step ahead of regulations rather than fumble through a damage control mode.

How to Achieve Effective Document Control

Now that you know what document control is all about, let us take a look at some of the most important aspects of effective document control.

1. Hire a Document Controller

A document controller/document control specialist is the person responsible for all document control procedures. If your organization is a mid-sized or a large one, you may have more than one document controller. Since the role requires technical proficiency in more than one area, it is advisable to have several document controllers.

2. Choose the Correct Document Control Software

With a proper Document Control Software solution, your organization will have an advantage over your competitors.

Such software can safely store all crucial documents in the cloud and should have the tools for data organization and easy search, navigation capabilities.

The software must support different document types, including PDFs, Word documents, image files, spreadsheets, and others. Another important aspect you will need to consider is that the software must be fully compliant with FDA 21 CFR Part 11.

Another important requirement for most life science organizations is that the Document Control Software is Computer System Validated – in compliance with FDA 21 CFR Part 11 and eventually ISO 13485:2016.

3. Have a Procedure for Document Control

As already mentioned in the sub-section on ‘Document control procedures, your organization must have a proper manual of document control procedures for achieving effective document control.

Therefore, make sure to ask your Document Control Software vendor if they can provide this document.

4. Continuous Improvement Is Needed

As your organization becomes more established, you will need to improve and update your document control management.

The rebuilding process can appear daunting, but by breaking each process into manageable tasks, you can achieve it more easily than you thought possible.

What Is a Document Control Software

Document control software allows your organization to automate records of all management policies, regulate access to sensitive information, and have thorough information of the activity of all documents for auditing and submissions.

When you substitute your paper-based document control procedures for an electronic document control software (EDMS), you will have a system wherein quality and compliance are guaranteed. With such EDMS, you can manage information and files following regulations and standards like FDA and ISO.

In the case of the life sciences industry, EDMS is typically referred to as an Electronic Quality Management System (eQMS). EQMS helps you manage all your QMS processes.

Let us look at a couple of examples from the life sciences industry to understand this better.

With an eQMS such as SimplerQMS, you will not only manage all your QMS processes confidently, but you will also have enhanced decision-making abilities, visibility, and preparedness for FDA 21 CFR Part 820, ISO 13485:2016, the EU MDR, FDA 21 CFR Part 11, and GxP.

The SimplerQMS eQMS solution allows for seamless collaboration between your organization and others (vendors, clients, and regulatory agencies), better standardization, simplified review and approval processing, and efficient interfacing with Microsoft Office Suite.

Recommended Reading: How to Choose Quality Management Software?

Document Control Automation

With the help of an eQMS such as SimplerQMS, several stages of document control are impacted beneficially.

1. Document Creation and Routing

Automation helps in differentiating between documents, such as policy documents and design documents.

They are then allocated their workflow, routing, review, and approval. Therefore, the document is reviewed and approved by the right people.

2. Document Version Control

Automation will help in the change request process that guarantees that all version changes to a document are according to the processes defined by your organization.

Document Control Software will safeguard that all changes related to a given document are in a single workflow. Also, older versions of the document are automatically archived.

3. Notifications

All internal and external users are automatically alerted when the required information has arrived/been processed and it’s their time to take action.

4. Document Backup and Disaster Recovery

Data backups are executed automatically, every 15 minutes, and stored in multiple locations around the world, and monitored by professionals 24/7.

You avoid storing these documents physically in your organization and you have a ready insurance policy against the loss or damage to these records.

Frequently Asked Questions on Document Control

Final Thoughts

When you work in the life sciences industry, you will be dealing with information day in and day out. This information must have a proper flow, be accurate, accessible, secured, and up-to-date. All this is possible with proper document control protocols and procedures.

With eQMS such as SimplerQMS, your organization will not only manage all QMS processes assuredly, but you will also have enhanced decision-making abilities, visibility, and preparedness for national and international regulatory standards such as the FDA 21 CFR Part 820.40, FDA 21 CFR Part 11, ISO 13485:2016, EU MDR and GxP.

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