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
- 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
- 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:
You can download the Assessment Worksheet by clicking here.
Dr Günter Brendelberger