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.
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.
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.
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.
Access essential training and resources for Part 11 and Annex 11 at Validation Center, ProPharma knowledge center and resource.
Attend free webinars, enroll in online and in-person classes in the US and Europe, and download valuable templates and standard operating procedures. Validation Center offers everything you need for Part 11, Annex 11, and other validation and compliance training and resources.
October 2, 2025
Discover how ProPharma's medical information services in the Netherlands ensure patient safety, regulatory compliance, and data privacy with expert support.
September 30, 2025
Discover essential tips for preparing a successful FDA 510(k) submission. Learn common pitfalls to avoid, align with FDA expectations, and streamline your path to clearance.
September 26, 2025
Insights from FDA’s latest round of compliance letters which indicates a major shift in ad promo oversight revealing new compliance risks for Sponsors.
July 8, 2025
ProPharma appoints former FDA labeling expert as VP, Labeling & Strategy, enhancing strategic labeling, promotional review, and regulatory consulting expertise to accelerate drug development and...
January 31, 2025
ProPharma wins Silver at ECCCSA for AI innovation in Medical Information, enhancing efficiency and quality in delivering accurate medical information.
October 21, 2024
ProPharma appoints Brian Tuttle as CFO to drive financial strategy and accelerate global growth, leveraging his 20 years of life sciences industry experience.
-chcecklist-complete-guide-fda-510k-submissions-ppg.png?width=320&height=185&name=510(k)-chcecklist-complete-guide-fda-510k-submissions-ppg.png)
