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.

The flexible object-oriented database design allows individual components of the database (objects) to be managed in different audit regimes according to the local requirements (full-tracking, only logging, restoring allowed or not, overwriting deleted allowed or not, etc.). For example, all experimental data and sample information (fingerprints, characters, sequences, information fields...) can be fully audited along with the entire processing flow, while comparisons (clusterings, dimensionings) can be left unaudited or logged only.

The Audit Trails and Versioning tools add great power and value to one of BioNumerics' cornerstones, the database. In terms of user-friendliness, flexibility and possibilities, the implementation 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.
Required modules: 
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