Title21 CFR Part11

Food and Drug Admnistration Title 21 CFR Part 11:
The MaxxVault Software Solution

The Food and Drug Administration’s Code of Federal Regulations Title 21, Part 11 outlines “… the criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.”

The MaxxxVault Enterprise Server provides the tools necessary for organizations to maintain signatures on electronic documents in compliance with Title 21 CFR Part 11.

To begin with, a compliant systems used to store the documents must iteself be secure. Access to MaxxVault is controlled so only users with the appropriate profile and password are permitted access to the documents. Even then access is not completely unfettered. The multiple layers of security make it easy for the system administrators to restrict access at the search, folder and document levels. MaxxVault also makes it possible to restrict user function as well as access; certain users may have the ability to modify, sign, email and print  documents while others may only be able to view documents. This granularity of priviliges helps protect documents from unautorised access, tampering and distribution.

Furthermore, MaxxVault’s audit logs provides a complete document and user history. MaxxVault places a date and time stamp on all files at the database level and any activity performed with the document is tracked. Edited documents can also be saved as a new version of the document, providing a precise recording of changes. Along with the document history and document verisons, a complete system audit tracks user activity, including log-in and log-out times, document access, and over 60 other actions/activities, including viewing, printing, emailing or deletion of records. Far superior to any paper-based system and meeting the requirements for 21 CFR part 11, MaxxVault can illuminate the full history of your document repository.

While MaxxVault keeps documents secure it also facilitates proper document workflow and retention policies. MaxxVault can route documents to the appropriate user or users for approval and authentication. At each step in the workflow, users can be forced to verify that they have completed the required activities and even be permitted to electronically sign a document. MaxxVault places the signature on the page with a user name and date/time stamp while the workflow step captures the purpose of the signature, be it review, approval or endorsement. Requiring user authentication and permanently burned to a document, electronic signatures are legally binding. Likewise, documents that are signed with pen-and-ink can also be protected electronically in MaxxVault. Once signed, documents are scanned in as “Read Only”, preventing tampering or modification.

The MaxxVault Scheduler aids records managers in tracking the retention schedules for the documents stored in MaxxVault. Various types of documents have different lifecycles and MaxxVault can automate the tracking of them all. When a document has reached the end of its lifecycle, MaxxVault will notify the records manager that the documents are ready for destruction.

Finally, MaxxVault helps organizations maintain compliance with 21 CFR part 11 by storing data and documents their native and industry standard formats. Should any organization need to upgrade or otherwise migrate off MaxxVault in the future, they will find the documents in easily readable and transferable format. Metadata and documents can readily be moved into other systems as tehcnology changes.

Ensure your content is captured, stored, managed and disposed of following proper business practices.