21 CFR Part 11 is an FDA regulation that pertains to the use of electronic records and electronic signatures in the pharmaceutical and life science industries. 21 CFR Part 11 describes the “criteria for acceptance by FDA for electronic records, electronic signatures, and handwritten signatures executed to electronic records as equivalent to paper records”. The driving force for its creation was to enable the use of electronic technologies with the security and traceability nececessary toprevent fraud. This rule has been effective since August 20, 1997, and applies to all industry segments regulated by FDA.
21 CFR Part11 has important implications for any company using a computer that manufactures products under cGMPs, GLPs and GCPs. This rule also pertains to international companies that produce pharmaceutical products supplied to US markets. The FDA expects companies to be in compliance with Part 11 or to be executing a well-established plan within the company for becoming fully compliant. Companies that utilize computer systems are responsible for plans to assess, re-mediate and validate non-compliant systems, as well as to create standards and validate new systems.
Invensys Validation Technologieshas a dedicated group of pharmaceutical engineers and consultants focused on this industry and the regulations. Our solution includes a full range of validation services and procedures to help enable compliance to 21 CFR part 11. We leverage our expertise to provide systems, tools, policies and procedures for compliance. We work with you as a team to establish a step-wise approach for achieving compliance.
Guidance for Industry Part 11, Electronic Records: Electronic Signatures - Scope andApplication - This is the latest draft guidance from the FDA which reflects the FDAs current thinking on 21 CFR Part 11 (September 2003).
21 CFR Part 11. Electronic Records; Electronic Signatures; Final Rule Electronic Submissions; Final Rule. This document reflects the current law for electronic records and electronic signatures to prevent fraud and abuse in the manufacturing of products under the FDA. 21 CFR Part 11 Final Rule (August 1997).
