21 CFR Part 11 – Electronic Records and Electronic Signatures

On August 20, 1997, 21 CFR Part 11 on “Electronic Records and Signatures” of the US Food and Drug Administration (FDA) entered into force. Title 21 CFR Part 11 (hereinafter referred to as Part 11) contains the legal provisions and defines the FDA’s acceptance criteria for the use of electronic records and electronic signatures. Electronic records and signatures must be at least as trustworthy, reliable and equivalent to paper-based records.

Part 11 compliance is now the basis for the worldwide adoption of IT systems for data management in the pharmaceutical, food and related industries. The FDA requirements are not only applied in the pharmaceutical industry but also in other so-called life sciences (e.g. food technology, cosmetics and care products, etc.).

The requirements of Part 11 can be summarized in 3 core Topics:

  • Access protection and security
  • Audit Trail
  • Electronic Signatures (Electronic Signatures)

How DHC VISION can fulfill the requirements of Part 11 as well as the corresponding organizational measures of the customer is described in our “White Paper on 21 CFR Part 11 Conformity”. This document also contains a detailed system evaluation of the DHC VISION software with regard to Part 11 compliance. You can request the e-Paper here.

In order to ensure that the requirements are met, a customer-specific 21 CFR Part 11 analysis and system evaluation is carried out as part of the validation activities for the implementation of DHC VISION as an annex to the validation plan, independently of the present document.

You can find our service offer for validation as well as the Validation Accelerators (completely prefabricated set of validation documentation) here.