21 CFR Part 11

Compliance with FDA regulations on electronic records and electronic signatures (21 CFR Part 11)

Title 21 CFR Part 11 is a U.S. federal regulation specifying FDA guidelines for electronic records and electronic signatures. It requires most companies that deal with the FDA, such as pharmaceutical companies and medical device manufacturers, to implement controls that ensure the integrity of their documents. Statgraphics customers regulated by the Food and Drug Administration (FDA) have asked about the 21 CFR part 11 compliance of Statgraphics software products with the FDA regulation on electronic records and electronic signatures (21 CFR Part 11).

Beginning with version 16.2, Statgraphics Centurion provides the ability to add passwords and user signatures to StatFolios as well as automatic creation of an audit trail to record the date and time at which Statfolios are changed to work as FDA compliance software for 21 CFR Part 11.

The extent to which a regulated company satisfies 21 CFR part 11 compliance does not depend exclusively on whether the Statgraphics software is compliant, but also on how the regulated company uses Statgraphics in its research and data analyses. Regulated companies are responsible for validating their processes and systems that use Statgraphics, as well as for adhering to the guidelines for electronic record keeping and electronic signatures. The use of Statgraphics by itself does not ensure that users are compliant with this regulation, only with proper usage can Statgraphics function as FDA compliance software. Secure record keeping requires a system that satisfies all the components described by the Title 21 regulations, and specifically the FDA Part 11 compliance guideline.

Statpoint recommends that customers contact the FDA for the most up-to-date information on the 21 CFR part 11 compliance. The current 21 CFR Part 11 and the Guidance for Industry Part 11 documents or FDA compliance software are both available on the www.fda.gov website.

Other links for 21 CFR part 11 guidance:

CFR Title 21 Part 11

Guidance for Industry Part 11, Electronic Records; Electronic Signatures — Scope and Application