Audit Trails module

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.

The Audit Trails module adds 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.

Features:

Audit trails and versioning

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 signatures

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

BioNumerics can be used in an FDA 21 CFR Part 11 compliant setting since it provides all the tools and functions required for keeping electronic records. The compliance is applicable to all BioNumerics components and functions and extends to all BioNumerics plugin tools.