The medical and pharmaceutical industry places specific requirements on software to ensure that completed actions are traceable. testXpert III testing software offers the following tools to meet these requirements:
- User management (LDAP) is included in the standard delivery
- Expanded traceability in accordance with FDA 21 CFR Part 11 is an option; it includes the functions for electronic records and electronic signatures.
This combination of tools ensures that test results are protected from manipulation at all times and that modifications and test results are traceable. Together with the organizational measures and procedure instructions that apply to the individual companies themselves, the requirements of FDA in 21 CFR Part 11 are fulfilled.