Compliance with FDA 21 CFR 11 Electronic Records; Electronic Signature and EU Annex 11 Computerised Systems is a must for the pharmaceutical, biotech, medical device, and clinical research industries.

Whether you need to get into compliance with Part 11 and Annex 11, provide verification of compliance, or simply ensure that your IT vendors are compliant, we can help.

If you have a Part 11 or Annex 11 challenge, let us be part of your solution.

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How We Approach Software Compliance Audits

Our regulatory compliance experts can help your program at any stage.

  • Part 11 and Annex 11 Gap Assessments

    Part 11 and Annex 11 Gap Assessments

    When you have an important upcoming inspection or customer audit, we can conduct a Part 11 or Annex 11 Gap Assessment to let you know where your systems are compliant and where they’re not.

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  • Part 11 and Annex 11 Compliance

    Part 11 and Annex 11 Compliance

    If your organization’s growth depends on compliance with Part 11 or Annex 11, we have the experts you need to get your systems, procedures, validation documents, and employees ready.

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  • Compliance Verification Audits

    Compliance Verification Audits

    Need independent verification of compliance with key regulations such as Part 11 and Annex 11? We can audit your systems, processes, and records to provide an objective certification to share with your customers.

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  • IT Vendor Audits

    IT Vendor Audits

    Regulators require organization to assess and approve suppliers of critical IT infrastructure and software applications. Hire an experienced, certified auditor to audit IT providers on your behalf.

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