Image Lab Software, Security Edition, is a module for Image Lab Software that assists users in meeting the FDA's regulations for cGMP environments in the pharmaceutical and biotechnology industries. Image Lab Software, Security Edition, works in conjunction with the built-in security features of the Microsoft Windows 7 (32- and 64-bit) and Windows 10 (64-bit) operating systems to provide a security environment for the maintenance, verification, and tracking of all electronic records generated by Image Lab Software. When properly configured and administered, these tools ensure compliance with the rules for secure handling of electronic records as outlined in Title 21, Part 11 of the Code of Federal Regulations (CFR).
- Access controls and authority checks via user identification codes and passwords
- Electronic record security via protected directories
- Time- and date- stamped audit trails
- Electronic signature of electronic records (user authentication)
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