Part 11 and Annex 11 Gap Assessments
ProPharma’s consultants have many years of industry experience implementing Part 11 and Annex 11. They leverage this experience to provide your organization with the benefits of a Part 11 or Annex 11 Gap Assessment, including:
Time to proactively remediate any critical deficiencies before an audit, rather than having them discovered by a regulator or customer
Insight to focus audit preparation activities on only those areas that need attention.
Confidence in the success of the next audit or inspection of your systems.
Part 11 & Annex 11 Compliance Experts
ProPharma’s Part 11 and Annex 11 experts follow risk-based GxP principles to prioritize the processes and systems to assess. They know which areas auditors are most likely to target and apply the following approach to assessing your systems and software validation procedures.
Part 11 & Annex 11 Compliance Assessment Approach
Meet with you to discuss your industry, your products, and your markets to determine the exact section of Part 11 and Annex 11 with which you need to comply.
Discuss any specific areas of concern. For example, you might feel confident about your software quality policies, but are uncertain whether or not your validation documentation will withstand...
Tailor ProPharma’s standard 200+ question Part 11 and Annex 11 assessment checklist to place the focus on the areas that are most important to your organization.
Conduct the Assessment in a manner similar to a regulator or potential customer. We ask the same tough questions, inspect your evidence, and challenge your practices.
Provide a Part 11 and Annex 11 Assessment Report with ratings for each question. Areas of non-compliance will be categorized as either “critical”, “major”, or “minor” in alignment with a risk-based...
Deliver a Compliance Action Plan with a list of specific, prioritized activities to complete to achieve Part 11 and Annex 11 compliance.
Host follow-up meetings to ensure that you understand the Part 11 and Annex 11 assessment results and recommended remediation activities.
Computer System Compliance
Part 11 and Annex 11 contain very specific functional requirements for regulated systems. ProPharma’s consultants work with your technical experts to determine the specific system configurations needed for compliance. When systems require customization, they review the designs to ensure that the end-result will be compliant from the first release.
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