e-regulatory

  • Cloud based, compliant, electronic regulatory and document management

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21 CFR Part 11 Compliant

Complion’s cloud based platform is the accepted standard for regulatory and document management.
Specifically built for research sites, Complion increases efficiency, saves time, and provides more compliance than traditional, paper based systems.

 
 

fewer trips and hours

Remotely accessing site research files improves the monitoring process and reduces the time necessary to be on site.

ready for an inspection

Organize your documents and search files easier.
Standardize "binders" template or create folders on the fly.
Track all documents and user actions in an automatic audit trail.

compliant, productive sites

Complion enables sites to meet the FDA and GCP requirements of owning, controlling and validating their own file system.
Your sites can now manage everything electronically within one system without any original paper copies or wet-ink signatures.

connected to site files

Both the sites and the sponsor can view archived documents on the platform.
Export the documents as needed so that they can be provided to trial master file teams.

21 CFR Part 11 Compliant

Complion is 100% Part 11 compliant and meets ICH GCP.
Unlike a shared drive, CTMS or sponsor portal, it allows you to control and maintain your documentation entirely electronically.