The Part 11 compliance in Pharmaceutical and food companies talks about the requirements that are necessary to run properly your pharmaceutical or food services with all the regulations that the FDA (Food and Drug Administration) needs. Part 11 compliant standard is the regulation established for e-signatures, auditing, and record keeping. Regulations like the FDA request that your Learning Management System (LMS) is validated for intended use in LMS part 11 compliant.
Title 21 CFR Part 11, commonly known as Part 11 compliant regulation, is the section of the Code of Federal Regulations (CFR) that deals with Food and Drug Administration (FDA) guidelines on electronic records and electronic signatures in the United States. It defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records.
In order to comply with the specified regulations dictated by law, an LMS must count with specific characteristics in its system settings, such as the ability to track the events developed inside the platform. Also, it must have a compliant storage capacity and an e-signature featuring.