Document Management System for Life Sciences
Streamline the management of your company–wide documents all in one system!
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Document Management Built Into a Comprehensive eQMS Solution
SimplerQMS offers Document Management and Document Control as integral parts of the comprehensive Life Science QMS software. SimplerQMS supports not only Quality documents but also other types of documents typically stored in file drives or SharePoint.
The system helps ensure compliance and efficiency in handling regulated documents and extends beyond to provide a holistic solution for managing all company documents. Alongside Document Management and Document Control, SimplerQMS includes QMS modules like change control, design control, audit, supplier, nonconformance/deviation, CAPA management, and more.
Store a Wide Range of Documents
Our Life Science document management system supports various types of non-regulated documents, such as:
Marketing Plans and Collaterals
Sales Proposals, Quotes, Contracts
Product Datasheets and Brochures
Financial Reports and Budgets
Research and Development Notes
Human Resources Forms
Emails
Manage Documents in the Cloud
All company documents—regulatory or non-regulatory—are stored in one centralized, secure location.
Access documents from anywhere with our Microsoft Azure Cloud Data Centers, ensuring high-level security.
Build Relations Between Documents
Our document management solution allows you to effortlessly relate documents to specific items within the system.
Link various types of documents, whether regulated or non-regulated, to each other for seamless traceability and improved workflow.
Automated Notifications
Set automatic email notifications for document actions and ensure everyone is on track with their activities.
For example, you can create a periodic task to review a specific document once a year if necessary.
Out-of-the-Box Regulatory Compliance
SimplerQMS helps you comply with a wide range of Life Science requirements.
Our software supports compliance with Life Science requirements, such as GxP, ISO 13485:2016, 21 CFR Part 820, ISO 9001:2015, EU MDR and IVDR, 21 CFR Part 11 and EU GMP Annex 11, and others.
Flexible Access Control
Define the access permissions for different types of documents.
Secure your sensitive HR, financial, or business strategy documents with role-based permissions.
What Customers Achieve By Implementing SimplerQMS
Utilize Proven Technology
SimplerQMS is built on Microsoft & M-Files Technology which serves over 5,000 customers worldwide.
Pass Audit More Easily
Access needed documentation and present it to the auditor with a couple of clicks from anywhere in the world.
Gain High Level of Traceability
Gain cross-functional visibility and trace back to the root cause of each nonconformance.
“It’s very flexible, smooth, and easy to use. Documents no longer get lost and the whole history of all products is accessible for anyone at any time.”
Discover How SimplerQMS Can Help You
Far Beyond Just Document Management
Change Management
Recognize and manage all changes accordingly to ensure compliance and structure within your QMS.
Audit Management
Simplify audit processes by effectively planning, executing, and tracking internal and external audits.
Supplier Management
Streamline supplier quality management processes from qualification to performance monitoring.
Training Management
Save time with automated training activities, notifications, reminders, and learning progress overviews.
Complaint Management
Efficiently track, manage, and resolve customer complaints in a timely manner.
CAPA Management
Manage CAPA activities seamlessly from identification to resolution and reporting.
Frequently Asked Questions
What Is a Life Science Document Management System?
A Life Science Document Management System (DMS) is a specialized software solution designed to manage, organize, and store documents and information in the field of Life Sciences, which includes industries like pharmaceuticals, biotechnology, medical devices, and others.
A DMS helps Life Science companies streamline their document-related processes, reduce the risk of errors, and improve overall efficiency in document management.
How Does Document Management Differ from Document Control?
Document Management and Document Control are integral components of a comprehensive Quality Management System, but they serve different operational and compliance needs within a company.
Document Management resembles an organized filing system for all your non-regulated business documents. It is a centralized repository to store, organize, and retrieve everything from marketing materials to sales reports and financial documents.
On the other hand, Document Control operates as a secure vault designed for regulated documents that must comply with specific industry requirements. Document Control encompasses more complex features such as document approval and change control workflows. For example, in developing a clinical trial protocol, the document might need to be reviewed and approved by multiple experts. Changes to the document are tracked and controlled to ensure that only authorized personnel can make them.
To sum it all up, Document Management is the general document organization and storage, while Document Control is about document rigorous supervision, secure access, and ensuring compliance with regulatory requirements.
Both are essential and supported by our platform. You can manage all your documents effectively, whether subject to strict regulations or not.
Who Can Access the Documents?
Access is role-based and can be controlled by system administrators. As a system administrator, you have the flexibility to set permissions according to site, department, document type, and even specific project teams.
Is Data Secure?
Absolutely. SimplerQMS document management solution uses state-of-the-art Microsoft Azure Cloud Data Centers, ensuring your data is secure.
Can I Link Non-Regulated Documents To Regulated Ones?
Yes, in SimplerQMS, you can link any document to any item within the system, whether it is a regulated document or not.
Is There a Storage Limit for the Document Management System?
SimplerQMS solution offers a minimum default storage capacity of 50GB, equivalent to approximately 150,000 documents.
This capacity can be scaled up to larger storage limits, including 1 terabyte and beyond, as needed, ensuring flexibility and adaptability for accommodating increasing volumes of documents and data.
How Do I Migrate My Existing Non-Regulated Documents to the System?
You can use a drag-and-drop method to migrate your existing documents to the new system.
This allows you to transfer documents either individually or in batches. Select the documents you want to migrate from your local computer and drag them into SimplerQMS.
How Much Does Life Science Document Management System Cost?
SimplerQMS pricing is based on the number and types of licenses you acquire.
Document Management System is a part of our comprehensive QMS software solution.
SimplerQMS provides all Life Science QMS modules, hosting, validation, implementation, user training, and ongoing support for a single subscription price depending on the number and types of licenses. There are no additional fees.
For more information on SimplerQMS pricing and included features and services, please visit our pricing page.
See What Our Customers Have to Say
“Spending most of my day using SimplerQMS, I would say I am very pleased with the ease of use.”
Dorthe W.
QA/RA Manager, Cortex Technology
“SimplerQMS gave us excellent pricing, customer support for understanding how to use their system and set up our QMS, and is easy to use.”
Subba S.
Chief Technology Officer, CollaMedix
“Easy to work with. Intuitive. Rather easy to setup. Very good customer support. Good quality to price ratio.”
Jean Claude M.
Head of Hardware and Software Development, hemotune
See SimplerQMS in Action
To see SimplerQMS in action and learn how you can make the most of it, request a personalized demo presentation.