FDA plans meeting to go over 21 CFR Part 11
in June to re-examine its regulations on electronic records and
signatures, used to generate the audit trail in the food and drug
industries, to examine whether some elements are putting an
unnecessary burden on industry.
Since the regulations (21 CFR part 11) became effective in August 1997, significant concerns have been raised that some interpretations of the requirements are far more expensive than originally anticipated to meet, and may even unnecessarily restrict the use of electronic technology.
This has led to suggestions that the rule can in fact discourage innovation and technological advances. The agency has decided to hear comments on the regulation as part of its revamp of the current Good Manufacturing Practice (cGMP) rules for human and animal drugs and biologics.
The FDA has already suggested that the scope of 21 CFR Part 11 could be narrowed to cover only a portion of the records that need to be maintained in manufacturing and quality control processes. For example, one issue that has been raised it whether using a computer to print out a record would trigger the need for 21 CFR Part 11 compliance.
"We are interested in comments on whether revisions to definitions in part 11 would help clarify a narrow approach and suggestions for any such revisions," said the agency in a federal register document.
The public meeting will be held on 11 June
