If you’re in the life sciences industry and are considering IBM Maximo for regulated uses, we’ve got good news: it’s capable of 21 CFR Part 11 compliance!
And, if you’re not familiar with 21 CFR Part 11, Perficient has the ultimate guide to help you.
Here are the three key areas of the regulation that govern the use of electronic records and electronic signatures for pharmaceutical, biotechnology, and medical device companies:
- General Provisions Electronic records falls under Part 11 of the U.S. FDA Code of Federal Regulations. It’s up to your organization to prove the trustworthiness of electronic records and signatures during an audit. 21 CFR Part 11 outlines the FDA’s requirements to use electronic records instead of paper records.
- Electronic Records When using electronic records, you and your organization must have the necessary procedures and controls in place. Things like authenticity, integrity, confidentiality, and irrefutability are required qualities. A few other topics include audit trails, workflows, accountability, and document controls. When using electronic signatures, the name of the signer, date/time, and the “meaning” of the signature, must be included.
- Electronic Signatures Don’t forget to inform the FDA that you plan to use electronic signatures before switching from paper to electronic signatures/records! The individuals associated with the signatures must have their identity confirmed and use a unique signature that is only used by them. Be sure to follow the specific design requirements when setting up electronic signatures.
If you are interested in learning more about how IBM Maximo complies with 21 CFR Part 11, please fill out the “contact us” form in the footer of this page.