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.


How we help research sites meet CFR Part 11 requirements:


Software


  • Our software is designed specifically for clinical trial site files and provides the required audit trails, eSignatures and access controls


Validation


  • For every site and with every software update, we walk you through software validation in a single meeting
  • Alternatively, we support your own validation process, and always provide education and document templates


Procedures


  • We support you every step of the way in developing the required policies and SOPs for research sites and in training staff
  • We maintain vendor SOPs that are regularly audited by third parties for software development and validation, as well as HIPAA security and privacy


Hosting


  • Our data center is highly secure with documented SOPs for the management of new software installation/validation, backups and disaster recovery
  • Alternatively, we can help you develop the required policies and SOPs for onsite installation