M-Files takes the hassle out of document and content management for pharmaceutical and life sciences organizations by streamlining how documents, electronic records, reports and other data and important processes are organized, managed, tracked and audited.
We can help you comply with the electronic records and signatures requirements of FDA 21 CFR Part 11 and EU GMP Annex 11. By supporting electronic signatures, maintaining a detailed audit trail of all document activity and securely tracking activity by individual, M-Files gives you the controls to ensure compliance.
Manage and track electronic records through their lifecycle, from creation to eventual disposal. Policies and processes associated with the capture, retention and disposal of records can be easily defined according to your organization’s requirements.
Seamlessly manage regulatory and “current Good Manufacturing Process” (cGMP) documentation, including batch records, lab reports, clinical documents, project files, specifications, plans and more. Manage documentation associated with Standard Operating Procedures (SOPs) and Corrective and Preventative Actions (CAPAs). You can also manage and track general business documents associated with basic day-to-day operations, as well as email and paper documents, including integrated scanning with OCR (Optical Character Recognition) for “full-text” search. Once stored in M-Files, all documents are indexed and searchable for instant retrieval, with access to the “right” document assured due to M-Files' integrated version history – no searching through chaotic, hard-to-manage folders. Simply click save and tag your file.
M-Files' flexible workflow and notification features can automate anything from simple approval processes to sophisticated, multi-step workflows with multiple stakeholders, assignments and notifications. Configure workflows to route information to the right people for follow-up and approval, and notify others when tasks are complete. Eliminate manual and paper processes for immediate productivity gains – while reducing errors, delays and time to market.