We have been there in front of US and international regulators and behind the scenes providing system compliance audit and inspection support. Our consultants have many years of experience in the pharmaceutical and medical device industries. We know all of the common audit pitfalls and red flags and can quickly help you get prepared.

If you are facing an FDA inspection, EMA inspection, or customer audit, it’s not too late to get help.

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How We Approach Software Compliance Audits

Our validation experts can help your project at any stage.

  • Audit Readiness Assessment

    When you have an important upcoming customer audit or FDA inspection, we can perform an audit readiness assessment to show you where your systems are compliant, and where they’re not.

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  • Audit Preparation

    Once an assessment has been completed, we immediately begin to address high-risk areas through implementation of remediated SOPs, retrospective validation, training, etc.

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  • Third Party Audits

    Regulators expect companies to assess and approve the vendors of their critical software and systems. Hire an experienced, certified auditor to audit system suppliers on your behalf.

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