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1: Quality Systems:

Audit & Assessment



Audit and Assessment of existing studies, documentation, practices, policies, procedures, evidence, etc.
Triage observations in terms of practical compliance approaches.

We audit for Validation using a Risk-based Approach.  Failure to comply with the Quality System Regulation can cause serious consequences for pharmaceutical and medical device manufacturers, including 483s, warning letters, consent decrees and more. We ensure you will comply with cGMPs and ensure processes are validated and completed to ensure product safety.  It is essential to audit to the quality system environment.

We focus on the FDAs emphasis on a risk-based approach. We use audit tools that can be used to verify effectiveness of such systems, and develop effective internal auditing techniques.




Audits can be conducted before or after a regulatory inspection, however we would encourage the use of our audits to assist you in readiness and personnel development, project tracking and implementation of your overall Improvement Programs.  The types of audits we specialize in are:
  • General Quality System audits. 
  • Process validation audits.
  • Complaint Handling
  • Medical Device Reports
  • Design History Files
  • Device Master Records
  • Device History Files
  • Comparison of report text to the study protocol, procedures, compendia, and analysis plan
  • Central Files Auditing
  • Data Systems Auditing
  • Statistical Systems Auditing



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