Datacor understand the unique challenges facing its FDA compliant users and offers a comprehensive Validation Toolkit to assist in complying with required software validation documentation. It provides a “roadmap” to follow throughout the validation process and it presented in an easy-to understand format. The Validation Toolkit also includes the necessary analyses, checklists, procedures, walkthroughs, reviews and test cases to assist users to quickly and effectively validate their software.
Datacor understand the unique challenges facing its FDA compliant users and offers a comprehensive Validation Toolkit to assist in complying with required software validation documentation. It provides a “roadmap” to follow throughout the validation process and it presented in an easy-to understand format. The Validation Toolkit also includes the necessary analyses, checklists, procedures, walkthroughs, reviews and test cases to assist users to quickly and effectively validate their software.

Validation Plan

Datacor utilizes a 4Q life cycle Validation Plan (Design Qualification, Installation Qualification, Operational Qualification and Performance Qualification).

 

datacor_validation_toolkit.png

Validation Toolkit Documents Include:

  1. Introduction and Roadmap to Validation
  2. Master Validation Plan
  3. Design Qualification (DQ)
  4. Risk Assessment and Management
  5. Vendor Qualification (VQ)
  6. Development and QC Protocol
  7. Hardware Specifications (HS)
  8. Installation Qualification (IQ) for Install
  9. Installation Qualification (IQ) for Upgrades
  10. Operational Qualification (OQ)
  11. Performance Qualification (PQ)
  12. Support and Maintenance
  13. SOP and Chance Control
  14. Complying with U.S. FDA Title 21 CFR Part 11

 

Request Sample Toolkit