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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.

Product Datasheet - Document Management System

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

Integrate With Microsoft Office

Enjoy the freedom to work with familiar Microsoft Office applications like Word, Excel, PowerPoint, and Outlook.

Make your transition to our document management solution as smooth as possible.

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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.

Create Documents From Templates

The document management system simplifies the process of document creation by offering a range of customizable templates for commonly used documents.

The system also allows you to use your own document templates.

Explore form and template management capabilities

Template list in SimplerQMS
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Work Across Departments Seamlessly

Store, share, and collaborate on a wide variety of documents across departments, for example, Product, Marketing, Sales, HR, and more.

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.

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Maintain Collaborative Workspaces

Work on documents collaboratively with team members, track changes, and maintain document version histories.

Cross-Functional Search Capability

Quickly retrieve any document—an HR document, a marketing brochure, or a financial spreadsheet—with our powerful search functionality.

Efficiently categorize, label, and search for documents, making document retrieval quick and easy.

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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.

Document and Life Science Requirements
User Access Controls

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 With 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.”

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Christian Schärfe Thomsen

Project Manager, Cortex

Discover How SimplerQMS Can Help You

Far Beyond Just Document Management

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Document Control

Keep your documents audit-ready while managing a high volume of data accurately.

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Training Management

Develop employee competence while maintaining compliance. Streamline the training process with learning rules and training groups, automate task assignments, reminders, and more.

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Change Management

Streamline change control processes from change request submission to final approval and successful implementation.

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Deviation Management

Enhance investigation, documentation, and resolution of deviations through a streamlined deviation management process.

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CAPA Management

Enhance your corrective and preventive actions to enforce continuous improvement and resolve issues as they arise.

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Complaint Management

Streamline your complaint management workflow and turn complaints into product improvement opportunities and increase customer satisfaction.

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Audit Management

Reduce the time and effort needed to pass audits successfully by streamlining audit-related activities.

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Risk Management

Consolidate and organize risk management documentation throughout all quality processes.

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Equipment Management

Simplify the equipment registration, calibration, and maintenance tasks with straightforward workflows.

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Supplier Management

Manage your supplier quality management processes across your supply chains, from initial qualification and selection through ongoing monitoring and performance measurement.

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Frequently Asked Questions

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.

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.

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.

Absolutely. SimplerQMS document management solution uses state-of-the-art Microsoft Azure Cloud Data Centers, ensuring your data is secure.

Yes, in SimplerQMS, you can link any document to any item within the system, whether it is a regulated document or not.

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.

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.

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.

What Our Customers Say

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Star review

“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

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Star review

“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

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Star review

“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.

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