This module enables all changes to any database object in BioNumerics to be recorded in audit trails. It allows the entire BioNumerics platform to be used in compliance with the strictest Good Manufacturing Practice regulations, such as FDA 21 CFR Part 11 (see also BioNumerics FDA 21CFR11 Compliance).

The Audit Trails & Versioning tools add great power and value to one of BioNumerics' cornerstones, the database. In terms of user-friendliness, flexibility and possibilities, it goes far beyond the requirements of FDA 21 CFR Part 11, making the system also an invaluable asset for institutions and companies that do not require this compliance but have interest in the increased data management power, i.e.:

• Full logging of all actions per user;
• Keeping all versions for every changed object;
• Viewing full editing history per object, per class of objects or for the entire database;
• Comparing any two versions with each other in a convenient readable report that highlights the changes, deletions and insertions in different colors;
• Creating full detail XML reports of versions and comparisons between versions;
• Restoring previous versions of objects after erroneous changes;
• Digitally signing objects that are final and approved.

Versioning
Along with each change made to an object, the previous version of the object is automatically stored including time and user data. In combination with the User and Security tools (see under Database), Create, Modify, Delete, Sign, Restore, Lock and Unlock privileges can be granted to specific users. Any previous version of an object can be compared to the current version and when allowed by the privilege settings, previous versions can be restored by authorized users.

Audit trails
The audit trail can be viewed for any particular object, for specific classes of objects or for all audited objects in the database. The audit trail coverage can range from logging only to full tracking, and optionally, deleted objects can be prevented from being overwritten.

Digital signatures
The digital signature tools are useful in environments where data needs to be validated by authorized persons and are fully compatible with FDA 21 CFR Part 11 requirements. Secure digital signature key pairs can be used by authorized users to sign and validate final processed data entries and/or any further changes made. The software can check for the validity of digital signatures and for any fraudulent changes made to the data after digitally signing.

Features:

• Audit trails. Enables all changes to any database object in BioNumerics to be recorded and versioned in audit trails. Trailing strength ranges from logging only to full tracking. In full tracking mode, all previous versions of objects are automatically stored including time and user data. Audit trails can be viewed for particular objects, classes of objects or all audit-trailed objects. Previous versions of an object can optionally be restored.
• Digital signing. Secure digital signature key pairs can be used by authorized users to sign and validate final processed data entries and/or any further changes made. Checks for the validity of digital signatures and for any fraudulent changes made to the data after digitally signing.
• FDA 21 CFR Part 11 compliance. This module works on all objects known to BioNumerics and allows the entire BioNumerics software, including the plugin tools, to be used in compliance with FDA 21 CFR Part 11.

This module can only be used in combination with the Database Sharing Tools module.