Regulatory and 21 CFR Part 11 Audits

Gap Analysis
We perform reviews of systems for Part 11 compliance that include:

  • Risk Assessment
  • Validation
  • Change control
  • System maintenance

We have performed gap analysis of electronic, paper, and hybrid systems for Part 11 compliance and potential validation deficiencies. The gap analysis reports are then used to prepare remediation plans to address the items identified in the gap analysis.

Audits
We conduct Part 11 compliance audits both internally for our clients as well as of third-party vendors/suppliers on behalf of our clients.

Remediation
When a system does not fulfill the requirements of Part 11 or contains validation deficiencies, we can identify a remediation solution. When a procedural solution is feasible and appropriate, we write a procedure that addresses the observation. Remediation can also include the implementation or upgrade of the current system to a 21 CFR Part 11 solution.

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