Mindy Robinson
Registered
Must DHR records be originals or can they be copies?
Thanks in advance!
Mindy C Robinson
Thanks in advance!
Mindy C Robinson
DHR Records
- Thread starter Mindy Robinson
- Start date
FDA Accepts part 11 Compliant Copies.
4. Copies of Records
277
278 The Agency intends to exercise enforcement discretion with regard to specific part 11
279 requirements for generating copies of records (§ 11.10 (b) and any corresponding requirement in
280 §11.30). You should provide an investigator with reasonable and useful access to records during
281 an inspection. All records held by you are subject to inspection in accordance with predicate
282 rules (e.g., §§ 211.180(c), (d), and 108.35(c)(3)(ii)).
283
284 We recommend that you supply copies of electronic records by:
285
286 · Producing copies of records held in common portable formats when records are
287 maintained in these formats
288 · Using established automated conversion or export methods, where available, to make
289 copies in a more common format (examples of such formats include, but are not limited
290 to, PDF, XML, or SGML)
6 Various guidance documents on information security are available (see References).
7 In this guidance document, we use the term legacy system to describe systems already in operation before the
effective date of part 11.
291 In each case, we recommend that the copying process used produces copies that preserve the
292 content and meaning of the record. If you have the ability to search, sort, or trend part 11
293 records, copies given to the Agency should provide the same capability if it is reasonable and
294 technically feasible. You should allow inspection, review, and copying of records in a human
295 readable form at your site using your hardware and following your established procedures and
296 techniques for accessing records.
While the FDA accepts copies they expect copies to have the same utility as originals (searchable, etc)
4. Copies of Records
277
278 The Agency intends to exercise enforcement discretion with regard to specific part 11
279 requirements for generating copies of records (§ 11.10 (b) and any corresponding requirement in
280 §11.30). You should provide an investigator with reasonable and useful access to records during
281 an inspection. All records held by you are subject to inspection in accordance with predicate
282 rules (e.g., §§ 211.180(c), (d), and 108.35(c)(3)(ii)).
283
284 We recommend that you supply copies of electronic records by:
285
286 · Producing copies of records held in common portable formats when records are
287 maintained in these formats
288 · Using established automated conversion or export methods, where available, to make
289 copies in a more common format (examples of such formats include, but are not limited
290 to, PDF, XML, or SGML)
6 Various guidance documents on information security are available (see References).
7 In this guidance document, we use the term legacy system to describe systems already in operation before the
effective date of part 11.
291 In each case, we recommend that the copying process used produces copies that preserve the
292 content and meaning of the record. If you have the ability to search, sort, or trend part 11
293 records, copies given to the Agency should provide the same capability if it is reasonable and
294 technically feasible. You should allow inspection, review, and copying of records in a human
295 readable form at your site using your hardware and following your established procedures and
296 techniques for accessing records.
While the FDA accepts copies they expect copies to have the same utility as originals (searchable, etc)
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