How to be 21 CFR Part 11 FDA Compliant with an LMS solution

It is not possible for any vendor to offer a turnkey 21 CFR “Part 11 compliant system.” Any vendor who makes such a claim is incorrect. Part 11 requires that both procedural controls (i.e. notification, training, SOPs, administration), and administrative controls are put in place by the user, in addition to the technical controls that the vendor can offer. At best, the vendor can offer an application containing the technical requirements of a compliant system.

21 CFR Part 11 FDA Compliance

Policy requirements within an organization cover the company’s interpretation of the regulation.

Section 11.10 (a)

The system shall be validated to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.

Section 11.10 (c)

Written procedures shall be established and adhered to, to ensure protection of records to enable their accurate and ready retrieval throughout the records retention period.

Section 11.10 (j)

Written policies shall be established and adhered to, which hold individuals accountable and responsible for actions initiated under their electronic signatures, in order to deter record and signature falsification.

11.100 (b)

The system owner shall verify the identity of an individual prior to the establishing, assigning, certifying or otherwise sanctioning an individual’s electronic signature, or any element of such electronic signature.

11.100 (c)

The system owner shall certify to the agency that the electronic signatures in their system are intended to be the legally binding equivalent of traditional handwritten signatures, prior to using electronic signatures.

11.100 (c) (1)

The system owner shall submit this certification in hand-signed paper format the Office of Regional Operations (HFC-100), 5600 Fishers Lane, Rockville, MD 20857.

11.100 (c) (2)

The system owner shall upon agency request, provide additional certification or testimony that a specific electronic signature is the legally binding equivalent of the signer’s handwritten signature.

About SyberWorks

With over 25 years experience delivering technology to meet the needs of highly regulated organizations, SyberWorks is the market leader in tailored, compliant learning experiences.