Issues with Medical Device Part 11 Electronic Records; Electronic Signatures

摘要

The use of electronic records and electronic signatures is increasing-not just in regulated industries. These types of issues will be seen in all industries that require legally binding documentation. Most professionals already deal with encrypted transactions on the Internet and hope that companies have similar systems in place to ensure integrity versus the growing danger of identity theft. The type of information and verification/validation required in 21 CFR Part 11 will be replicated and expanded upon worldwide, not only in medical products, but in finance, legal, and all business entities desiring a viable global business model.