FDA 21 CFR part 11 compliance

This license for tablet hardness testers of the P-Series and H-Series complies with FDA 21 CFR part 11 requirements. It is an optional software license ideal for GxP, pharmaceutical R&D, manufacturing in-process and quality control laboratories, which require proper electronic record keeping. It includes user management, access control, electronic signatures, security, data integrity and audit trail functionality.

Electronic Code of Federal Regulations

User Management

Individual role based access control provides password protected access and control of the tablet hardness tester. You can create multiple user accounts with different access rights which are handled in a hierarchic structure.

Electronic Signature

Measurement data is saved by confirming login name and password. Saved files include the user name/author, login name, date and time for proper electronic record keeping. PDF files cannot be altered and ensure data integrity.

Audit Trail

The audit trail automatically records all actions and preference changes in an audit log. The audit log contains a sequence ID, time stamp, user ID and category for each action. Audit trails can be saved as a PDF and printed by an Administrator for documentation purposes.