Breathe easy knowing your site is compliant
It’s all in our name
Complion’s team of certified research professionals has developed deep expertise in Part 11 compliance. Not only is our platform part 11 compliant, we are the only software vendor that will partner with you to do everything required for compliance, including system validation, training support 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.