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Clinical Research IO Receives 21 CFR Part 11 and Annex 11 Attestation from Advarra


CRIO recently received attestation from Kinetiq (now Advarra) that our policies and procedures conform to the requirements of 21 CFR part 11 and Annex 11. Part 11 is the FDA’s requirement for use of electronic data in clinical trials, which is a part of Good Clinical Practice (GCP) and Good Documentation Practice (GDP). Annex 11 is widely viewed as the FDA equivalent in the European Union.

We recently received attestation from Kinetiq, the Consulting division of Quorum review IRB, that our policies and procedures conform to the requirements of 21 CFR part 11 and Annex 11. Part 11 is the FDA’s requirement for use of electronic data in clinical trials, and Annex 11 is widely viewed as the FDA equivalent in the European Union.


As the leading eSource (electronic source) provider for clinical trial sites, we wanted to provide our clients with independent assurance of our compliance with the FDA’s Good Clinical Practice (GCP), Good Documentation Practice (GDP), and 21 CFR Part 11, which applies specifically to electronic data in clinical trials.

Increasingly, as more clinical trial data goes electronic, sponsors and investigators are scrutinizing their clinical trial software vendors to minimize the risk of an adverse FDA audit finding. Having an external party like Advarra, which specializes in FDA compliance, audit our systems provides an extra level of protection.

The review itself was extremely rigorous. Advarra’s project team sent an experienced former auditor to CRIO, who had qualified software vendors for a Top 10 pharma company. Advarra interviewed personnel, visited our data centre, and reviewed our policies and procedures. They made a number of recommendations. This resulted in CRIO updating our software development lifecycle, our validation practices, our access control and security measures, and other procedures.

We are a much better company for having gone through this. Our processes are more robust and durable. Our staff is better educated.

Compliance is a process of continuous improvement, and we anticipate making improvements each year. We have a strong foundation as we expand into other software modules that will fall under the governance of the FDA and European Union regulators.

While our attestation provides assurance that CRIO’s clinical trial software is compliant under 21 CFR Part 11, we note that clinical trial sites must understand that they bear ultimate responsibility for complying with 21 CFR Part 11 (and/or its European Union equivalent, Annex 11). That means that sites need to do certain things, such as implementing a list of SOP?s and performing user validation of the system. To help our clients, we provide them with sample SOPs and user validation scripts.

If you’re interested in learning more about the steps we take to stay 21 CFR Part 11 Compliant, click here to book a meeting with a team member!

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