The recorded information will assure your company’s internal and external stakeholders, including regulatory agencies, that each and every product is being manufactured according to industry standards and Good Manufacturing Practices (GMPs).

In this article, we will be taking a deep look at what are Electronic Batch Records, their importance and requirements, as well as key areas to consider when transitioning to Electronic Batch Record management.

But first, let us look at the basics:

• What Is a Batch Record and Why Is It Important?
• What Is an Electronic Batch Record?
• What Are the Benefits of Electronic Batch Records?
• What Are the Requirements for Electronic Batch Records?
• What Does an Electronic Batch Record contain?
• Making the Move to Electronic Batch Records
• Choosing the Right Electronic Batch Records Solution

What Is a Batch Record and Why Is It Important?

In the context of your life sciences (be it a Medical Device, Pharmaceutical, Biotechnology, Cell & Gene industry), a Batch Record is defined as the documentation that will provide the entire manufacturing history of every batch of product that you manufacture.

Every Batch Record is of the utmost importance since it records the equipment, materials, staff, data, labels, events, supplies, laboratory information management systems, process control systems, and enterprise resource planning. This means that every Batch Record will contain the complete in-process and release tests. This information is the assurance to your company’s stakeholders, both internal and external, including the regulatory agencies that your products are manufactured as per the most stringent industry standards. 

We can understand this better with the following example.

Your Quality Assurance Department has detected a nonconformance in one of your products during an inspection. The department will now check the other products from the same batch, using the details provided in the Batch Record, to see whether the nonconformance applies to more products.

A Batch Record can also be labeled as a Batch Manufacturing Record (BMR) or a Batch Production Record (BPR). Batch records can include a single unit as is the case for a single patient’s data, for instance, if your company is manufacturing precision gene therapy products. It can also be for 100s of units of a given product.

It should be noted here that the US Food and Drug Administration (US FDA) expects not only medical device manufacturers and pharmaceutical companies to maintain Batch Records, but also companies manufacturing dietary supplements, gene therapy products, and others to do the same.

What Is the Difference Between a Master Batch Record and a Batch Record?

The main difference between a Master Batch Record and a Batch Record is that a Batch Record is a batch-specific copy of the Master Batch Record. This means that each Batch Record shows evidence that a particular batch was manufactured in accordance with the instructions in the Master Batch Record.

What Is an Electronic Batch Record?

When batch records are generated and stored electronically, they are referred to as Electronic Batch Records or EBRs, for short. Irrespective of your life sciences company, you will be generating huge amounts of documents via Electronic Batch Records and maintenance of product records for every batch of products that your company manufactures.

For your company to facilitate compliance using Electronic Batch Records, you will require dedicated software tools. For example, these include specialized tools such as Manufacturing Execution Systems (MES), Enterprise Resource Planning (ERP), and others. An Electronic Quality Management System (eQMS) like SimplerQMS can also be used for a more simple EBR management. An eQMS system allows you to work more efficiently and helps ensure compliance with the necessary regulatory requirements when you are dealing with documents and records, including EBRs.

Electronic Batch Records Software built into SimplerQMS allows your personnel seamlessly and easily create, store, and retrieve Electronic Batch Records. You are assured that these records are secure, and unlike traditional methods of document management, you will never lose or misplace any document.

What Are the Benefits of Electronic Batch Records?

When a life sciences company implements Electronic Batch Records, it accrues various benefits. These benefits can be broadly categorized as follows.

Reduction of Human Error

Human error, including misplacing or losing documents, routing documents to the wrong locations, and others, result in wastage of precious time, money, re-audits, and possibly loss of brand value.

For example, there is an audit in process, and your personnel is running helter-skelter trying to locate the Batch Records of a particular product.

With the implementation of an efficient Electronic Batch Record management solution or an eQMS like SimplerQMS, you will not face such problems. At the click of a mouse, you will be able to produce the relevant document for the inspectors.

Compliance With Regulatory Requirements

To be compliant with current regulatory requirements, your life sciences company needs to capture accurate information in the form of data and records, organize this information, and present it in a suitable manner.

With traditional paper-based documentation systems, these processes become cumbersome.

Imagine the scenario where the Quality Department in your medical devices company has been asked to present the batch records for a specific batch of implantable pacemakers to the auditors from the US FDA. Considering that your company produces numerous batches of this device every year, it will become very difficult to manually search and identify the given batch.

On the other hand, by using Electronic Batch Record systems, the Quality Personnel can get the required information within seconds.

Reduction in Warehouse Inventories (Optimizing Manufacturing Processes)

If a life sciences company is using manual processes for capturing complex data for batch records, it is most likely to face data integrity issues, errors with warehouse inventories that will result in the repetition of inventories, and other problems.

Let’s imagine that there has been an error with warehouse inventories of the HMG-CoA reductase inhibitor (Atorvastatin) that a pharmaceutical company is a leading manufacturer of. These types of errors have increased over the last few years because the company is persisting with manual paper-based documentation. Now, let us consider that the same company transitioned into Electronic Batch Records two years back –  the entire process would have been much more streamlined.

Electronic Batch Records will not only improve data integrity and accuracy but also help to streamline processes and optimize manufacturing process efficiency by reducing production cycle times and guaranteeing workflow consistency.

Improved Visibility/Traceability

Data storage is both difficult to access and disengaged when manual paper-based documentation systems are used. These inefficiencies result in traceability issues, especially when the company is facing an important audit.

After implementing EBRs, you are provided with a centralized storage location, document linking, electronic signatures, and much easier compliance with current regulatory guidelines.

What Are the Requirements for Electronic Batch Records?

The main regulatory requirements for batch records in the context of the life sciences industry including medical device and pharmaceutical industries are mentioned below.

Requirements for Medical Devices Companies

When medical device companies sell their products in the US market, they come under the purview of the US FDA. The overarching guidelines of the FDA are that every medical device must be safe and effective to use in its given clinical setting.

Medical device companies need to maintain a device history record for every medical device they manufacture and sell. This essentially is equivalent to a batch record.

21 CFR Part 820.184 states the following:

Each manufacturer shall maintain device history records (DHRs). Each manufacturer shall establish and maintain procedures to ensure that DHRs for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR and the requirements of this part. The DHR shall include, or refer to the location of, the following information:

a) The dates of manufacture;

b) The quantity manufactured;

c) The quantity released for distribution;

d) The acceptance records which demonstrate the device is manufactured in accordance with the DMR;

e) The primary identification label and labeling used for each production unit; and

f) Any unique device identifier (UDI) or Universal Product Code (UPC), and any other device identification(s) and control number(s) used.

These records will be in accordance with your company’s device master record.

21 CFR Part 820.181 states that every medical device manufacturer must maintain device master records that are prepared and approved as per regulatory requirements.

Overall, your medical devices company should be compliant with the FDA Quality System Regulations (QSR) as defined in 21 CFR Part 820.

21 CFR Part 820 states that:

Current good manufacturing practice (CGMP) requirements are set forth in this quality system regulation. The requirements in this part govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use.

This also means that you will need to follow the document control requirements laid out by 21 CFR Part 820.40.

Additionally, 21 CFR Part 11, and other requirements become mandatory if your company is handling documents electronically. More on this shortly.

Medical device companies selling their products in the European Union are governed by the European Medicines Agency (EMA) guidelines on Good Manufacturing Practices (GMPs).

EMA GMP Chapter 4 states that:

Good documentation constitutes an essential part of the quality assurance system and is key to operating in compliance with GMP requirements. The various types of documents and media used should be fully defined in the manufacturer’s Quality Management System. Documentation may exist in a variety of forms, including paper-based, electronic or photographic media.

Volume 4, Chapter 4 (Documentation) emphasizes that good documentation is crucial for the company’s QMS and for compliance with GMP requirements.

The company’s QMS must define the different types of documents and media that are used. Also, such documentation may be in different formats, including electronic media.

The EMA GMP Chapter 5 gives details on batch records. It mentions that the company should maintain batch numbers, the status of contents, designated product name/internal code reference, expiry date, and so on for all products.

Regulatory Requirements for Pharmaceutical Companies

When your company is dealing with pharmaceutical products, you will come under the purview of 21 CFR Part 211.188 when you are selling in the North American market and EU GMP guidelines when marketing in the European Union.

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

Requirements for Electronic Batch Records

In addition to the general requirements for batch records, there are also specific requirements for storing and managing them electronically.

US FDA 21 CFR Part 11

The US FDA 21 CFR Part 11 regulations apply to all records that the company maintains in electronic form. These include records that are created, modified, archived, maintained, retrieved, or transmitted in electronic formats. The regulation stipulates that electronic records and signatures are just as trustworthy and reliable as paper records. And they are to be treated as equivalent to paper records.

Recommended Reading: 21 CFR Part 11 Software Requirements [Explained]

EU Annex 11

The European Union’s Annex 11 (Computerized systems) will apply to all types of computerized systems that are used as part of your company’s GMP-regulated activities. Annex 11 stipulates that you need to have a validation plan in place for all computerized systems.

GAMP 5

Good Automated Manufacturing Practice 5 (GAMP 5) gives details for a recognized standard for computer system validation that will ensure quality for life sciences companies, including pharmaceutical and medical devices.

SimplerQMS’s platform is an ideal solution for life science companies to streamline their compliance with Electronic Batch Records and the overall Quality Management System. Out of the box, SimplerQMS addresses the requirements of 21 CFR Part 11, EU Annex 11, GAMP 5, FDA 21 CFR Part 820, and requirements.

What Does an Electronic Batch Record contain?

A typical Electronic Batch Record will contain the following elements.

• Header
• Table of contents
• Exception Summary
• Equipment/lines used
• Components/materials used and their weights and measures
• In-process and laboratory control results
• Actual batch record details
  • The date or dates of manufacture
  • The quantity of product in the given batch or lot
  • The quantity released for distribution
  • The acceptance records
  • Unique Device Identifier (UDI); Universal Product Code (UPC); or control numbers are used to identify the product
• Complete labeling control records
• Sampling
• Identification of personnel supervising or checking each step

A “One-Size-Fits-All” approach will not work when your company is Electronic Batch Records.

So, depending on whether the company is a medical device manufacturer or a pharmaceutical organization, the EBRs will be specific for that company.

QMS software solution by SimplerQMS allows you to generate Electronic Batch Records using a fully customizable document template. Furthermore, third-party software solutions such as an ERP can be used to pull data, which is then sent through the automated document workflow in SimplerQMS.

Making the Move to Electronic Batch Records

When you decide to implement Electronic Batch Records in your life sciences company, you will be streamlining the documentation and data collection processes, reducing errors associated with manual paper-based systems, and assuring yourself of compliance with regulatory standards.

With EBRs in place, you are now proving to your stakeholders, both internal and external, your commitment to recording each and every step in the production of a lot/unit/batch of manufactured product.

Now, let us consider the 3 crucial areas that you need to evaluate prior to making this crucial move.

• Organizational culture and people
• Business processes
• Technology

Organizational Culture and People

The changes that will arise with the implementation of Electronic Batch Records will affect the entire workforce of your company.

These changes will include staff interactions with each other, usage of data, maintenance of data integrity, and implementation of the new processes.

The senior management will need to highlight the importance of the impending changes and the direction the company is now looking at. This cultural shift from traditional paper-based documentation systems to the latest Electronic Batch Records management systems must be driven by the senior management. The acceptance will then permeate the entire workforce.

You will need to get input from all stakeholders. They should understand that their views are valuable. This means that communications should be a two-way process. An important point to be noted here is that specific personnel, such as the plant-force personnel, are the ones with the deepest knowledge about batch records. They are crucial to your implementation of a doable solution.

Plan ahead for workshops, seminars, and expert talks before bringing in Electronic Batch Records as an alternative to the existing data capture systems. This will prime your personnel about the importance of EBRs for the company.

You may also consider a roadmap to the deployment of Electronic Batch Records. Rather than implementing the system across the board, and then trying to handle multiple issues at the same time, you can implement the new system in one or smaller departments for a period of time. Test it out before a full rollout across the company.

Training is crucial for successful implementation. Maintenance staff, engineers, and operators must all be trained. They should understand the importance of accessing the right data at the correct time, and completing the tasks efficiently.

Business Processes

Data integrity is a decisive component of your company’s success. It will guarantee the authenticity and traceability of the data to its original source. Data integrity ensures that the right data has been collected and entered in the correct manner.

The ALCOA principle comes into play here. ALCOA is the acronym for Attributable, Legible, Contemporaneously recorded, Original or true copy, and Accurate. With this principle, you are assured that the data that is collected and recorded is reliable, and will pass the scrutiny of all stakeholders.

Technology

When you are planning your company for Electronic Batch Records, you also need to evaluate its integration with other enterprise systems. This is needed to support the free flow of information across the company.

Lastly, it is of utmost importance that all the solutions that your planning must be deployed in a validated environment.

A validated environment is one where all systems and processes have been tested and shown to meet the required standards. This is important for ensuring that Electronic Batch Records are deployed in a way that meets all regulatory requirements.

Choosing the Right Electronic Batch Records Solution

As mentioned earlier, the manual management of batch records comes with inherent challenges and inefficiencies. These include issues with data integrity, human error, security, and storage problems.

With efficient Electronic Batch Records solutions, you access assured data integrity, decreased human error-related problems, state-of-the-art security, and easier regulatory compliance.

Considering that huge amounts of documentation are generated for every new batch of a manufactured product, you should consider Electronic Batch Records as a suitable solution.

SimplerQMS offers an all-in-one QMS software solution that is specifically designed for life sciences companies. This system helps you manage all your quality processes inside a single platform, including change management, CAPA, document control, audits, and supplier management, as well as those processes related to electronic batch records.

Link batch records with other related documents – audit and inspection records, documented acceptance criteria, work instructions, standard operating protocols, device master records, nonconformance, equipment, products, and others.

With the SimplerQMS software solution, you are now able to easily create, store, and access the most recent records for any product with its complete data history.  There will no longer be worries about security and/or accessibility since all documents and records are securely stored in cloud-based storage facilities and can be easily located in a single place.

Final Thoughts

Every life sciences company must maintain batch records for every lot/unit/batch of manufactured products. They contain all the vital information and are a testimony to the company’s products.

Since traditional paper-based documentation systems are inherently flawed, you should consider implementing Electronic Batch Records. They will make life much easier for all concerned, including the regulatory agencies.

Consider SimplerQMS QMS software solution for your needs, if you are keen on streamlining your QMS activities, including Electronic Batch Records management processes, and ensuring compliance with applicable regulatory requirements.

Request a demo of our software solution today and see how we can help your business streamline its quality management activities!

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