21 CFR Part 11 Checklist

Although an FDA 21 CFR part 11 summary is available to discuss the

regulation’s interpretation by the FDA, 21 CFR part 11 can still be tricky
to navigate. To help you evaluate a system’s CFR 21-part 11 compliance,
we provide the following 21 CFR part 11 compliance checklist?
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info@gampservices.com

21 CFR Part 11 Checklist

1 Is the system validated per FDA and companypolicies and procedures?
2 Is the system's Part 11 functionality (e.g. audit trail mechanisms, detection of invalid/altered records) validated and has a vendor assessment
been done, applicable?
3 Can at least one validated, accurate, and completerepresentation of the electronic record be made available for transmission or presentation to the
FDA?
4 Is information content or interpretation, retrievable and/or reproducible and unaltered for the retention period of the record?
5 Are controls in place to ensure metadata, data attributes, or parameters that are integral to the content or meaning of an electronic record
retrievable and/or reproducible for the retentionperiod of the record?
6 Are controls in place to ensure processed or reduced data is retrievable and/or reproducible,and unaltered for the retention period of the
record?
7 Are controls in place to ensure that electronicallycaptured raw data is retained in electronic form for the retention period of the record?
8 For retained raw data, are controls in place to ensure that the ability to derive original results isretained for the retention period of the record?

9 Are controls in place to assure that associatedsignatures (electronic or handwritten capturedelectronically) are retrievable and/or reproducible,
and unaltered for the retention period of the record?
10 Are controls in place to assure that audit trails areretrievable and/or reproducible, and unaltered forthe retention period of the record?
We hope that 21 CFR Part 11 checklist presented here will help you evaluate current or proposed system
software and automated Equipment's.

If your business is interested in CFR 21-part 11 compliance for software and automated Equipment’s.

Contact our Experts at GAMP Services today to learn more about how we can help.

GAMP Services GAMP Services

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VIP main road, Karelibaug Near Parimal Garden Underpass
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www.gampservices.com
Ph: 9879594538 / 9879594375
Info@gampservices.com