Product/Service

21 CFR Part 11 Compliance Software

Source: Finesse, part of Thermo Fisher Scientific

21 CFR Part 11 Compliance Software

Title 21 CFR Part 11 is part of the FDA’s Code of Federal Regulations and was put in place so that when records are maintained in an electronic format, they’re still maintained in a manner equivalent to written records. Stringent electronic controls can be put in place to ensure compliance, but procedural controls should also be employed as well. This white paper explains how a specific type of software developed by Finesse can be used to maintain 21 CFP Part 11 compliance as it relates to cell culture and fermentation, both electronically and procedurally.

Title 21 CFR Part 11 is part of the FDA’s Code of Federal Regulations and was put in place so that when records are maintained in an electronic format, they’re still maintained in a manner equivalent to written records. Stringent electronic controls can be put in place to ensure compliance, but procedural controls should also be employed as well. This white paper explains how a specific type of software developed by Finesse can be used to maintain 21 CFP Part 11 compliance as it relates to cell culture and fermentation, both electronically and procedurally.