Etes-vous prêts à fournir vos enregistrements sous forme électronique ?
Un article récent pointe cet aspect particulier des inspections américaines :
Copies of Records
The Agency intends to exercise enforcement discretion with regard to specific part 11 requirements for generating copies of records (§ 11.10 (b) and any corresponding requirement in §11.30). You should provide an investigator with reasonable and useful access to records during an inspection. All records held by you are subject to inspection in accordance with predicate rules (e.g., §§ 211.180(c), (d), and 108.35(c)(3)(ii)).
We recommend that you supply copies of electronic records by:
In each case, we recommend that the copying process used produces copies that preserve the content and meaning of the record. If you have the ability to search, sort, or trend part 11 records, copies given to the Agency should provide the same capability if it is reasonable and technically feasible. You should allow inspection, review, and copying of records in a human readable form at your site using your hardware and following your established procedures and techniques for accessing records.
Are you ready to provide data in an electronic format?During inspections, it is the FDA’s expectation that information can be readily retrieved electronically. For example, common requests during inspections include CAPAs, nonconformance, complaint and change history documentation. Your company needs a defined process and procedures that outline how and by whom that information is obtained and how you will verify the accuracy of the documentation. Are your reports validated? And if not, how are they verified? Another best practice in this situation is to pull the data in advance to test your process and have a trained SME who can explain the electronic records in detail. You can answer yes to this question when you are ready to provide validated, verified data to an investigator in an electronic format.Même si cette exigence a été revue à la baisse avec le guide Scope & application de 2003, elle n'en reste pas moins requise avec les caractéristiques suivantes :
Copies of Records
The Agency intends to exercise enforcement discretion with regard to specific part 11 requirements for generating copies of records (§ 11.10 (b) and any corresponding requirement in §11.30). You should provide an investigator with reasonable and useful access to records during an inspection. All records held by you are subject to inspection in accordance with predicate rules (e.g., §§ 211.180(c), (d), and 108.35(c)(3)(ii)).
We recommend that you supply copies of electronic records by:
- Producing copies of records held in common portable formats when records are maintained in these formats
- Using established automated conversion or export methods, where available, to make copies in a more common format (examples of such formats include, but are not limited to, PDF, XML, or SGML)
In each case, we recommend that the copying process used produces copies that preserve the content and meaning of the record. If you have the ability to search, sort, or trend part 11 records, copies given to the Agency should provide the same capability if it is reasonable and technically feasible. You should allow inspection, review, and copying of records in a human readable form at your site using your hardware and following your established procedures and techniques for accessing records.
