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| Clark J. Kashmaier 971-217-5558 clark@kashmaier.com |
Part 11
The FDA issued "regulations that provide criteria for acceptance by FDA, under certain
circumstances, of electronic records, electronic signatures, and handwritten signatures
executed to electronic records as equivalent to paper records and handwritten signatures
executed on paper." (page 13420 of the Federal Register/Volume 62, No. 54/Thursday, March
20, 1997/Rules and Regulations)
While the actual regulations are reasonably short, the issuance of these regulations has
caused significant action and concern by those who fall under the jurisdiction of FDA
regulations.
In 2003, a Guidance for Industry Part 11, Electronic Records; Electronic Signatures -- Scope
and Application was issued by the FDA, in which (on lines 178-181) it states: "Records that
are required to be maintained under predicate rule requirements and that are maintained
in electronic format in place of paper format [fall under Part 11]. On the other hand, records
(and any associated signatures) that are not required to be retained under predicate rules,
but are nonetheless maintained in electronic format, are not part 11 records."
Link to FDA website concerning Part 11
Link to Part 11
The FDA issued "regulations that provide criteria for acceptance by FDA, under certain
circumstances, of electronic records, electronic signatures, and handwritten signatures
executed to electronic records as equivalent to paper records and handwritten signatures
executed on paper." (page 13420 of the Federal Register/Volume 62, No. 54/Thursday, March
20, 1997/Rules and Regulations)
While the actual regulations are reasonably short, the issuance of these regulations has
caused significant action and concern by those who fall under the jurisdiction of FDA
regulations.
In 2003, a Guidance for Industry Part 11, Electronic Records; Electronic Signatures -- Scope
and Application was issued by the FDA, in which (on lines 178-181) it states: "Records that
are required to be maintained under predicate rule requirements and that are maintained
in electronic format in place of paper format [fall under Part 11]. On the other hand, records
(and any associated signatures) that are not required to be retained under predicate rules,
but are nonetheless maintained in electronic format, are not part 11 records."
Link to FDA website concerning Part 11
Link to Part 11