Is SimpleTrials Validated or 21 CFR Part 11 Compliant?

Yes.

Validation

The SimpleTrials application has been fully validated with the oversight of an independent, 3rd party compliance consultancy. Additionally, formal qualifications of the data center and platform provider were performed by external compliance consultants. SimpleTrials is maintained in a validated state via a documented change control program with quarterly software updates including enhancements and fixes.

Administrator users have access to the ADMIN > COMPLIANCE PORTAL view, which contains the  compliance and validation documentation for SimpleTrials. Limited validation documentation is available to all clients. Comprehensive validation documentation is available via an add-on. For details on validation options and adds on see: Purchasing a Validation Package Add On.

A Validation Fact Sheet is also available in the COMPLIANCE PORTAL for all clients. This document provides more detail on the SimpleTrials validation options and pricing. 

The COMPLIANCE PORTAL view for a client who has purchased the Tier Two Validation package. 

21 CFR Part 11

SimpleTrials supports the features and controls needed for 21 CFR Part 11 compliance. The SimpleTrials validation activities include verification of 21 CFR Part 11 elements including system access restrictions, user account controls, audit trail, archival policy (non-deletion) and electronic signatures. NOTE: Achieving 21 CFR Part 11 compliance requires a collaborative effort between customer and provider (e.g. the customer has the necessary policies and procedures in place for the intended use of the application within their organization and the vendor has the necessary technical controls in place). The SimpleTrials validation packages contain additional 21 CFR Part 11 documentation including a checklist to help facilitate.