CFR Part 11 Compliance

US FDA Part 11 Compliance or EU Annex 11 Compliance

CFR Part 11 Compliance / EU Annex 11 Compliance – Ensuring Regulatory Compliance for Electronic Records and Signatures

In the world of regulated industries, maintaining compliance with the Code of Federal Regulations (CFR) Part 11 or the European Union (EU) Annex 11 is crucial for organizations utilizing computerized systems and electronic records. These regulations govern Electronic Records and Electronic Signatures (ERES), ensuring the integrity and reliability of data throughout manufacturing, testing, and release processes.

Our Services: Reviewing and Ensuring System Compliance with Part 11 / Annex 11

Are you uncertain about the compliance status of your computer system with CFR Part 11 or EU Annex 11? Our experts can help! Before starting a computer, system implementation or committing to any contracts, we offer comprehensive reviews to assess and ensure compliance with the current regulatory requirements.

For organizations with existing systems, our team will thoroughly review your setup to determine if compliance is achieved or if remediation actions are needed. By recommending the necessary steps to comply with 21 CFR Part 11 or PIC/S Annex 11, we can help you avoid potential compliance issues.

Avoid Over-Elaboration and Unnecessary Expenses – Rely on Our Expertise

We understand that companies often face the challenge of over-complicating compliance efforts, leading to unnecessary costs. However, with our experience and knowledge, we guide organizations in taking a risk-based approach and applying only the necessary measures, in line with the predicate rules.

Implementing Systems and Documentation for CFR Part 11 / EU Annex 11 Compliance

Our extensive experience in CFR Part 11 and EU Annex 11 compliance has allowed us to develop robust procedures and assessment templates. By leveraging our expertise, we ensure that your organization possesses the correct documentation required for compliance with CFRs and other regulatory standards. With our assistance, your next audit will be a success.

Learn More and Get in Touch with Our Compliance Experts

If you have computerized systems and electronic records, or you are considering their implementation and have concerns about compliance, our team is here to help. With offices around the world, we offer global support and guidance. Contact us today to have your questions answered, explore your compliance options, and ensure regulatory compliance with CFR Part 11 or EU Annex 11.

Get in Touch

If you would like to learn more about our services, request a quote or ask any questions please fill out our enquiry form here.