Breathe easy knowing your site is compliant
Complion’s team of certified research professionals has developed deep expertise in 21 CFR Part 11 regulations. Not only is our platform Part 11 compliant, we will partner with you to do everything required for compliance, including validation, training and process development.
Compliance is critical
Any research site using electronic records and signatures in clinical trials must comply with Rule 21 CFR Part 11 or risk an FDA audit. However, understanding and following the detailed regulations requires a significant amount of time, resources, and knowledge.
We help research sites meet 21 CFR Part 11 requirements
Learn more about 21 CFR Part 11 Compliance
Talk with one of our document management experts today!
Schedule a Consultation
Read the peer reviewed article featured in ACRP’s Clinical Researcher.
Download the Feature Article
Questions about regulations and compliance? Find an answer quickly.
Frequently Asked Questions
“Complion recognizes the importance of ensuring the highest standards of compliance are met. Unlike other software vendors we have worked with, the Complion implementation team and Mary Crowley collaborated together to develop the User Acceptance Test and execute the protocols in a matter of hours.”Yasmina Harb, Mary Crowley Cancer Research Centers