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


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

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.

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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

What Customers Say

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