21 CFR Part 11 Compliance

Experts in data compliance and regulatory frameworks

Labman have worked in partnership with global auditing organisations to develop best-in-class systems which facilitate CFR and GxP compliance.
The Camelot toolkit, developed by Labman Automation, is a Dynamic Linked Library (DLL) that can be incorporated into a Microsoft .NET application and provides a number of features and tools to allow you to become compliant with 21 CFR part 11 and GxP.

Camelot can be included in Labman’s custom software solutions or integrated into 3rd party systems to enable 21 CFR Part 11 and GxP compliance. Camelot’s secure data store holds all critical data values which can only be accessed via the Camelot Toolkit.

All areas of 21 CFR Part 11 compliance are covered by Camelot, including protection of records, audit trails, electronic signatures and report generation of secure data. The Camelot Toolkit API makes it a simple and intuitive system to use and to integrate into your existing system.

Please note that the Camelot system must be implemented hand in hand with appropriate company policies and standard operating procedures to reliably ensure 21 CFR Part 11 and GxP compliance.

FDA Requirements

User Permissions

A record of user permissions and an audit trail must be kept for every document within a company’s vault. CFR and GxP compliant systems must be able to unequivocally identify all people with access to a document, and when and by whom any document was edited or changed.

Electronic Signatures

Unamendable electronic signatures must link to their corresponding electronic records including name, date, time of signing and meaning of signature.

Document Approval

All possibility of falsification of a document approval must be removed, i.e. any approval given must be clearly and unreputedly traceable back to the approver.

Training

Compulsory and traceable training needs to be in place for all users of any electronic systems that deal with regulated data.

Secure Back-up

A reliable and secure back-up of data that includes all electronic signatures and required meta data must be in place.

Documented System

There must be clear and change-tracked documentation of the method of operation of the data/document management system itself.