Blueprint’s 21 CFR Part 11 / GMP Annex 11 Content Accelerator addresses electronic records and electronic signature compliance requirements. It is one of many powerful Content Accelerators in Blueprint’s large library of prepackaged requirements information.
With this Content Accelerator:
- Teams gain easy access to applicability checklists from within their Blueprint or Storyteller environment, so they can decide which technical controls apply to the systems their projects affect.
- Teams can quickly copy the relevant compliance requirements into their Blueprint or Storyteller requirements repository, where they can customize them and establish traceability to technical controls as needed.
- Teams can generate template-based reports with links to Blueprint and Storyteller artifacts to analyze and demonstrate regulatory compliance.
To learn more about how Blueprint’s 21 CFR Part 11 / GMP Annex 11 Content Accelerator and how we help organizations in regulated industries ensure compliance