Minitab and Compliance with CFR Title 21 – Part 11 - ID 2588

Revised: 2/16/2010

Applies to

  • Minitab 17
  • Minitab 16

Description

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

Solution

Minitab customers from industries regulated by the Food and Drug Administration (FDA) have asked about the compliance of Minitab software products with the FDA regulation on electronic records and electronic signatures (21 CFR Part 11). We want to help our customers use our products in accordance with the guidelines of all regulatory agencies, including the FDA.

Minitab Statistical Software provides password protection for opening, saving, and modifying project files. This protection serves as an electronic signature for validating the ongoing use and storage of Minitab project files. For complete control, password protection should be combined with a file or source control system to verify dates, times, and approved access. Minitab Statistical Software also provides a scripting language that can be archived along with validated output. The script and the output can be stored as part of a password-protected project file.

The extent to which a regulated company satisfies the FDA requirements does not depend exclusively on whether the Minitab software is compliant, but on how the regulated company uses Minitab as a tool in their research and their data analyses. Just as our customers are responsible for validating their processes and systems that use Minitab, they are also ultimately responsible for adhering to the guidelines for electronic record keeping and electronic signatures. In other words, the use of Minitab by itself does not make users compliant with this regulation. Providing audit trails and secure record keeping requires a system that satisfies all the components described by the Title 21 regulations, and specifically the Part 11 guideline.

Minitab recommends that our customers contact the FDA for the most up-to-date information on the Part 11 regulations. Both the current 21 CFR Part 11 document (the complete Code of Federal Regulations is revised annually) and the Guidance for Industry Part 11 document are available on the www.fda.gov website. Minitab also welcomes feedback from customers that may help to direct future software development of our products.

Note: Software validation may also be of interest to users in regulated industries. To learn more about the Minitab software validation process, software development life cycle, and other relevant information, click the link, Minitab Software Validation Kit, below.

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