21 CFR Part 11 Compliance

Title 21 CFR part 11 applies to companies in health-care, pharmaceutical, life-science, biotechnology, medical- manufacturing, medical-device, and other FDA-regulated industries. It enacts FDA's requirements that such organizations be able to recognize electronic records and electronic signatures as trustworthy, reliable, and legal equivalents to paper records and handwritten signatures. This allows companies to go to a “paperless” system of record keeping.

More specifically, 21 CFR part 11 requires enterprises to implement controls, including system validations, audit trails, electronic signatures, and documentation for software and systems that are involved in processing many forms of data as part of their business practices and product development.

NetDimensions is one of the few unique vendors in the industry supporting 21 CFR part 11 functionality within a Learning Management System. NetDimensions provides such compliance support as part of NetDimensions Learning along three main functionality areas:

  1. Auditing

    All changes made to sensitive data within NetDimensions Learning are audited in the database along with information on the type of change, who made the change, and when. Types of changes include creation, update, and deletion of sensitive data.

  2. Electronic Signatures

    Before every important operation in NetDimensions Learning, an electronic signature prompt appears, asking for user ID, password, and update meaning. These three parameters collectively form an e-signature. The user ID and password must be correct for the current user before the requested operation can be carried out

  3. Reporting

    All audited data is presented as standard NetDimensions Learning reports (for example, Audit Trail report and Audit Trail User Action report). This means users with appropriate permissions can view the audited information in various electronic formats like HTML, CSV, PDF, and Excel as with other standard system reports.

Validation Services

NetDimensions Learning was validated in 2011 for 21 CFR part 11 use in client implementations so that it meets FDA requirements. NetDimensions’ validation is practical, defensible, and in keeping with typical computer systems validations in the FDA-regulated industry. NetDimensions can also provide Learning Management System consulting services for NetDimensions Learning to be validated in client environments worldwide for intended use along 21 CFR part 11 requirements.