regulations

August 30, 2021
regulations compliance

Audit trail requirements on GxP computerized systems

According to Wikipedia an audit trail is a chronological record providing documentary evidence of the sequence of activities that have affected at any time a specific operation, procedure, event, or device. The first uses of audit trails date back to ancient civilizations when rudimentary methods emerged to manage goods, soldiers and financial transactions. Audit trails to ensure data integrity came into the spotlight when US regulation 21CFR Part 11 was issued in 1997. Part 11 requires the use of secure, […]