21 CFR Part 11 – Type of Controls Required

21 CFR Part 11 is the FDA regulation on electronic records and electronic signatures.

For definitions of the procedural and technological controls required to fully support 21 CFR Part 11, refer to 21 CFR Part 11 Technical Controls . The following responsibility abbreviations are used:

P – Pharmaceutical manufacturing organization that is going to use an Electronic Records/Electronic Signature (ER/ES) system in a regulated environment. Responsible for compliance of an ER/ES system with 21 CFR Part 11.

S – Supplier of an ER/ES system (this could, of course, be a separate internal function of the pharmaceutical organization, such as the Information Systems department). Responsible for delivery of suitable technology.

This table can be used by pharmaceutical organizations when carrying out audits of prospective suppliers of automated systems that are subject to 21 CFR Part 11. The existence of those controls identified as being the prime responsibility of the supplier should be checked during the audit, and action should be taken to address any deficiencies. It is recognized that not all of these technological controls are currently available in commercial software packages. Primary responsibilities for the controls are included in the table.

For a definition of each part of the standard and a brief explanation on how TMS addresses the standard, refer to 21 CFR Part 11 TMS Addresses.