Getting started is easy!
"Who does what when why and who is responsible?“
The electronic records function enables you to comprehensively document all actions and changes carried out in the testXpert III software so that they cannot be tampered with. Users define the degree to which the actions must be logged and possibly explained in accordance with their regulatory requirements (for example, changes to a test-relevant parameter such as test speed). This data is saved in the audit trail.
The regulation 21 CFR Part 11(Code of Federal Regulations) on electronic records and electronic signatures of the United States Food and Drug Administration (FDA) defines acceptance criteria for the use of electronic records and electronic signatures in place of records in paper form and handwritten signatures on paper. These electronic documents must be handled with as much confidentiality, be just as authoritative, and hold the same value as the paper documents.
Compliance with regulations FDA 21 CFR Part 11 and EU GMP guidelines Annex 11 on is required for use with electronic records and signatures in a regulated environment. It is still possible to use conventional paper documents and handwritten signatures.