Check List for Part-11 Systems

GMP News No. 200

GMP News
22 May 2002
 

Check List for Part-11 Systems

 
FDA's requirements on electronic records and electronic signatures as laid down in 21 CFR Part 11 still represent a real challenge to the pharmaceutical industry. What is most critical is the call for:
  • an Audit Trail
  • the possibility to make precise and complete copies
  • the long-term archiving of data

In order to guarantee Part-11 compliance, a pharmaceutical enterprise first has to list all its computer- based systems and then to judge whether these systems are GxP-relevant and whether they are furthermore covered by 21 CFR Part 11. For a detailed evaluation a "GAP Analysis" can be very helpful. The objective of such an analysis is to:

  • Specify the criteria under which electronic records, electronic signatures, and handwritten signatures executed to electronic records are considered equivalent to paper records and handwritten signatures executed on paper in accordance with 21 CFR Part 11 (the Regulation),
  • Evaluate a computerized system versus the established requirements, and
  • Document the evaluation of the computerized system.

The Assessment Worksheet (Internal Audit Document), for which you will find a download link below, is an excellent aid. In part 1 "System Classification Section" you can evaluate with the help of the check list whether 21 CFR Part 11 applies to the EDP system in question. In case the result confirms that Part-11 compliance is required, you can check by means of the "Assessment Section" whether the EDP system complies with all requirements of 21 CFR Part 11. In order to be able to answer all of the questions correctly, the part "Assessment Guidance" offers explanations and support.

Should your company have EDP systems to which 21 CFR Part 11 might apply, we recommend you the following seminar:

No. Date Title Location
359
19-20 June 2002 Electronic Records/Electronic Signatures - Implementation of 21 CFR Part 11 Frankfurt/M., Germany

You can download the Assessment Worksheet by clicking here.

Author: 
Dr Günter Brendelberger
CONCEPT HEIDELBERG

 

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