New document management and control solution enables internal and external collaboration while meeting the most rigorous standards in a trusted Microsoft secure cloud environment
We’re pleased to share that Merit GxP Documents is now available. This monthly subscription-based Software as a Service (SaaS) document management and control solution helps life science organizations follow GxP guidelines, ISO standards, and maintain FDA compliance. It can be used stand-alone or as part of the broader Merit for Life Science and Microsoft Dynamics 365 ERP solution.
“Working with an app that helps ensure collaboration and controls, e-signatures, and audit trail reporting isn’t just for large organizations. Merit GxP Docs offers biopharma and medical device companies a solution that is easily adopted by early-stage companies and scales to meet the needs of enterprises,” said Bill Burke, CEO of Merit Solutions. “Emerging companies shouldn’t have to depend on email or paper for reviews and approvals, nor should they sacrifice compliance.”
Merit GxP Docs supports the comprehensive document lifecycle—from creation, development, review, and publishing to change management and archival. With use cases across departments and support for secure collaboration with partners, Merit GxP Docs allows companies to establish document controls and FDA compliance early in their lifecycle, increasing the integrity of their data, supporting successful regulatory filing and provability of their science. Users can manage peer reviews, gain control of quality SOPs (Standard Operating Procedures), track validation documents, maintain compliance documents and process-specific instructions, analytical procedures, and more.
“Our 21 CFR Part 11 compliant solution for controlled document management built on the Azure platform provides a secure, collaboration platform with the ease-of-use that users expect in a modern workplace experience,” stated VP of Research and Development, Paul Challinor. “With technology threats increasing every day, it was crucial for us to offer our controlled document management solution as a cloud-first application in Azure. Merit GxP Docs is deeply integrated with Microsoft’s multi-layered security infrastructure, so our users can have confidence that their documents and their information are fully protected and secure.”
We invite you to learn how Merit for Life Science GxP Documents can help you automate the management of controlled documents across all product lifecycle stages, securely collaborate internally and with external partners, and ensure you meet GxP, ISO and FDA compliance regulations.