SimpleTrials is a fully validated system. Admin users for all clients have access to the ADMIN > COMPLIANCE PORTAL view, which includes some compliance documentation at no cost. Comprehensive validation documentation is available as an add-on. There are three level of validation packages.

Validation Options:

All Clients Access

SimpleTrials Validation Fact Sheet (general information for clients)
Vendor Survey (General Company Questionnaire)
Platform and Capabilities Overview
Release Notes
SOPs and general quality system documentation (excluding validation documentation)
Hosting Vendor Qualifications (Amazon Web Services and EngineYard Company)

Validation Package Tier One

All "All Clients Access" documents
Validation Summary Report (one per release)
Certification of Validation
21 Part 11 Checklist - Summary Version
Validation Master Process SOP

Validation Package Tier Two

All "Tier One" documents
User Requirement Specification, Functional Requirements Specification (~400 requirements)
Configuration Specification (80+ page document detailing default system settings and customer configurable options, including user roles, alerts, eVisit Reports, CTMS reports and form fields)
Test Cases - Performance Qualifications (PQ), Operational Qualifications (OQ) (1900+ test steps)
Trace Matrix (mapping of requirements to qualifications)
21 Part 11 Checklist - Detailed Version
Design Specification and Installation Qualification (IQ)
Executed Qualifications (IQ, OQ, PQ) and objective evidence

Validation Quality / Audit Support

A two hour audit call with two SimpleTrials senior team members to perform a virtual audit and/or discuss related topics (including meeting coordination and follow up).

The Validation Fact Sheet is available for all clients in the COMPLIANCE PORTAL. This is an excellent resource for more details on validation plans, options, pricing, and FAQ.

How to Purchase a Validation Add On

Navigate to the ADMIN > SUBSCRIPTION & SETTINGS view (Admins only)
Within the Subscription Add Ons sections, click the "Add" button
A new form will appear with the list of available add-ons. Select the Validation Tier appropriate for your needs.

Users Access Requirements	Admin
Portfolio View Access Requirements	All Data
Subscription Requirements	Trial, Standard, Premium, Premium for Sites, Premium Plus, Enterprise

Purchasing a Validation Package Add On