Daily Compliance Management – the efficient, affordable way.
Whether you’re a biotechnology firm, medical device manufacturer, clinical research organization or related business, M-Files QMS will help you automate and manage your daily compliance tasks.
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.
Top 5 Benefits for Pharmaceutical & Life Sciences Firms
FDA 21 CFR Part 11 compliance
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.
Instantly locate documents
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.
Improve collaboration and control
- Automatic version history maintains a record of every change.
- Check-in/check-out facilitates team collaboration and avoids conflicts and data loss when one person overwrites the changes of another.
- Secure access permissions by document with Windows Active Directory support.
- Log and audit trail records all document activity.
Request your free trial now, or contact us to learn more about using M-Files for your business.