In the sixth part of our series entitled, Important considerations when shopping for EDC, we will discuss allowing enough time to complete the validation testing.
Validation is a critical requirement of both 21 CFR Part 11 and of GCP. So permitting enough time for a thorough and complete validation is essential to demonstrating that your specific implementation of a prospective Electronic Data Capture System is compliant. The FDA believes validation “guarantees exactness, unwavering quality, reliable proposed execution and the capacity to perceive invalid or modified records.”
This implies that the sponsor has a methodology in place to validate EDC software for the intended use, and follow that procedure to evaluate and test the EDC Software which will be utilized to create agreeable electronic records and marks.
Once you have completed the steps above and purchased an EDC System, you can continue with testing the product to finish your validation. You will want to do the following:
- Configure the EDC System for your utilization
- Create documentation demonstrating the EDC System meets your requirements
- Build out and test your first protocol ensuring edit check testing, dynamic navigation, user rights and roles as well as page level controls
- Evaluation of security and environmental safeguards
- Data transfers, extracts and archival to sites should also be evaluated
Remember that configuration, testing and finishing the validation documentation can be tedious, particularly in the event that it’s your first time. If you have never been through the validation process, give yourself adequate time to thoroughly test and complete the validation process before you enter protocol information into the live production environment.
Next week, we will examine the upfront cost structure of an EDC System: Cost Vs. Benefits