Software Manual Freedom EVOware Standard 2.3 Freedom ...

B - Appendix B - FDA 21 CFR Part 11 Compliance
Related Documentation
B
Appendix B - FDA 21 CFR Part 11 Compliance
The United States Food and Drug Administration (FDA) issued a set of regulations
in 1997 that outlines its criteria for acceptance of electronic records, electronic
signatures and handwritten signatures (referred to as 21 CFR Part 11). The
regulations state the conditions under which the FDA considers electronic
signatures and electronic records to be trustworthy, reliable and equivalent to
traditional handwritten signatures on paper. The criteria were provided in
response to industry requests. In this manner, it defines the conditions under
which an organization must operate to meet its record keeping and record
submission requirements when it uses electronic records and signatures rather
than paper records and handwritten signatures.
The preamble to the 21 CFR Part 11 rule states that “the use of electronic records
as well as their submission to the FDA is voluntary”. However, where an
organization does decide to use electronic records and electronic signatures, the
requirements must be met in full for all relevant electronic records. Organizations
that wish to operate under 21 CFR Part 11 must take the steps described in this
appendix to ensure complete compliance.
B.1 Related Documentation
The following publications from the FDA contain useful information on the 21 CFR
Part 11 regulations:
21 CFR Part 11, Electronic Records; Electronic Signatures; Final Rule;
Department of Health and Human Services, Food and Drug Administration, March
20, 1997;
Guidance for Industry – 21 CFR Part 11 – Electronic Records & Electronic
Signatures – Maintenance of Electronic Records;
Guidance for Industry – 21 CFR Part 11 – Electronic Records & Electronic
Signatures – Glossary of Terms.
B.2 Purpose of this Appendix
This appendix discusses the major requirements of the 21 CFR Part 11
regulations and details the technical features which have been implemented in the
Tecan Freedom EVOware software to help Tecan customers to reach compliance.
It also indicates which steps the Tecan customers must carry out to achieve
compliance.
The main part of this appendix discusses the relevant issues in the 21 CFR Part
11 regulations rule by rule and identifies how Freedom EVOware helps to ensure
compliance with the regulations and what Tecan customers must do to achieve
compliance. Refer to the FDA website and FDA publications for the full text of the
regulations.
The regulations primarily require analytical laboratories to consider the following
points:
• The use of validated equipment and computer systems,
• Secure retention of electronic records to instantly reconstruct analyses,
• Computer-generated, time-stamped audit trails,
Freedom EVOware Software Manual, 393172, en, V2.3 B - 1