QAI assists regulated companies evaluate their level of compliance with the ERES requirements of 21 CFR Part 11.  Within the predicate rules requirements, whether GLP or GCP.  The results of the gap analysis are then used by the client to implement corrective actions.  Personnel training may also be provided to improve compliance with the regulations.

Assessment

  • Evaluate existing systems
  • Gap analysis to Part 11 and to predicate rule

Computer System Validation

  • Master Validation Plan
  • Testing Validation Plan
  • Audit testing results

Training

  • Introduction to electronic signatures
  • Introduction to electronic records