21CFR Part 11
21CFR part11 and Audit Trail Management
- User access profile options, Operator, Manage, Administrator.
- Full audit trail management and maintenance functions.
- Audit trail Calibration and Calibration Check.
- Audit trail Test Specifications Setup.
- Additional audit trail for each historic test with duplicate relevant entries.
TQSoft provides a full suite of controls and features allowing encrypted security management and enabling Electronic Signature and Audit Trail logging.
The audit trail is updated automatically by TQSoft. TQSoft will not run if the audit trail is disabled in any way. Audit trail records and lists every relevant data modification made by the operator and allows reason entry, and records details of changes made, and archives files for restore!
TQSoft even has Audit Trail maintenance, management and archive functions!
