GMP Compliance, validatioN and project management services

21 cfr part 11

IRP Consulting provides 21 CFR Part 11  compliance assessments, remediation, consulting, and training for global-leading pharmaceutical and medical device manufacturers throughout the world.

Our 21 CRF Part 11 enagagements typically involve:

  • Performing Gap Analyses of existing systems to determine areas of non-compliance. Activities include but are not limited to: Reviewing the authenticity, integrity, and confidentiality of electronic records

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  • Verifying user access/security protocols


  • Reviewing the control and proof mechanisms that are in place to track and check invalidation of records


  •  Analyzing audit trails of electronic records and the handling of electronic records


  • Reviewing Change Control measures


  • Recommending and/or Applying Appropriate Remediation: Where gaps have been identified, recommendations are made to bring systems into full compliance. Remedial actions include but are not limited to:

               -Revising SOPs Standard Operating Procedures

               -Auditing Software Designs/Code Modules

               -Investigating or implementing industry offerings that may best suite our client needs


Our commitment to our customers is to apply our knowledge of and critical experience with FDA regulations, and apply best practices that help clients meet their compliance goals and better understand how to implement methods on their own to ensure future success.