ePath Learning ASAP, our online learning management service, supports FDA 21 CFR Part 11 compliance requirements for organizations in medical, healthcare, pharmaceutical, biotechnology, manufacturing, medical device, and other FDA regulated industries. Title 21 CFR Part 11 requires companies to implement controls, including audits, system validations, audit trails, electronic signatures, and documentation for software and systems that are involved in processing electronic data, as part of their business practices and product development.
Title 21 CFR Part 11 of the Code of Federal Regulations sets forth the requirements, which define the criteria under which the FDA considers electronic records and electronic signatures trustworthy, reliable, and legal equivalents to paper records and handwritten signatures. Currently, under the FDA, there are no formal requirements for vendors; therefore, vendors cannot guarantee compliance or claim certification in 21 CFR Part 11. No such certification exists. 21 CFR 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. What the vendor can offer is an application containing the technical requirements of a compliant system.
ePath Learning ASAP functionality including audit trails, tracking, qualification and validations have enabled our clients to meet the FDA 21 CFR Part 11 training requirements. Additionally, ASAP’s robust reporting function has simplified the inspector/auditor review process. ePath Learning ASAP has enabled our clients to reduce the costs and time associated with FDA requirements and to feel confident in their Part 11 compliance.