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We Hired an Official Review Team to Stress Test our Part 11 Compliance

Learn the results of our recent Part 11 Compliance Review.

10/4/2018 | By Raymond Nomizu, Co-Founder |

Part 11

CRIO Passes Rigorous Part 11 Review


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.

Kinetiq logo

As an eSource provider, we wanted to provide our clients with independent assurance of our compliance. Increasingly, as more clinical trial data goes electronic, sponsors and investigators are scrutinizing their vendors to minimize the risk of an adverse audit finding. Having a third party audit our systems provides an extra level of protection.

The review itself was extremely rigorous. The project team sent an experienced former auditor who had qualified software vendors for a Top 10 pharma company. The team interviewed personnel, visited our data centre, and reviewed our policies and procedures. They made a number of recommendations, resulting in our 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 review process. Our SOPs 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 "our end" is covered, sites must understand that they bear ultimate responsibility for complying with 21 CFR Part 11 (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.

Learn more about the steps we take to stay Part 11 and Annex 11 compliant!


Raymond, CRIO's co-founder

Raymond Nomizu is a Harvard-trained lawyer and former clinical trial site owner; during the operation of his site, he realized that there should be a better software solution for clinical trials. This prompted him to co-found Clinical Research IO, whose eSource and CTMS solutions are now considered some of the best in the industry. Read more about him here.

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