Common Uses and Benefits of Document Management

Organize and manage "Good Manufacturing Process" (cGMP), Standard Operating Procedures (SOP) and Corrective and Preventative Actions (CAPA) documentation, including forms, batch records, lab reports, clinical documents, and more.

Classify and index documents and records by product, project, date, or any other property or criteria.

Search and retrieve documents instantly by typing in a tag or keyword or two, or by searching on any word in the document using "full-text" search.

Automate processes for review and approval, retention and disposal, or any other important process or workflow associated with documents and records.

Ensure compliance with regulations such as FDA 21 CFR Part 11.

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Easy and Affordable Document Management for Pharmaceutical and Life Sciences Companies

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M-Files document management in Pharmaceutical and Life Sciences industries

M-Files document management helps pharmaceutical and life sciences companies such as biotechnology firms, medical device manufacturers and clinical research organizations, manage critical processes and all paper and electronic records and documents to ensure compliance with regulations and standards.

Regulatory compliance: FDA 21 CFR Part 11

M-Files provides direct support for compliance with FDA 21 CFR Part 11 related to managing electronic records and electronic signatures. By maintaining a detailed audit trail of all document activity, and securely tracking such activity by individual, with support for electronic signatures, M-Files provides the controls necessary for pharmaceutical companies, medical device manufacturers and others to ensure compliance with such standards and regulations.

Records management

M-Files offers all the tools necessary to 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 as required by the organization.

Manage and instantly locate any type of document including paper and email

M-Files' document management capabilities enable seamless management of regulatory and "Good Manufacturing Process" (cGMP) documentation, including batch records, lab reports, clinical documents, as well as project files, specifications and plans, and more. Manage documentation associated with Standard Operating Procedures (SOP) and Corrective and Preventative Actions (CAPA). General business documents associated with the basic day-to-day operations can also be managed and tracked. Email and paper documents are seamlessly supported, 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. M-Files eliminates chaotic and hard to manage Windows folders with an easy method of classifying and organizing documents by any property or tag, such as project, document type, date, etc. No more searching for where to save a file, just save to the vault and tag.

Automate processes for improvements in quality and productivity

M-Files' flexible workflow and notifications features can automate essentially any process from simple approval processes to sophisticated, multi-step workflows with multiple stakeholders, assignments and notifications. Easily customizable workflows can route information to the right people for follow-up and approval, and notify others when tasks are complete. Manual and paper processes are eliminated providing immediate gains in productivity, with a reduction in errors and delays leading to reduced time-to-market and higher quality.

Improved 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.

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