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FDA Validation Toolkit

Datacor understands the unique challenges facing FDA compliant users and offers a comprehensive Validation Toolkit to assist in complying with required software validation documentation. This guide provides a roadmap for the validation process 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 use of the Datacor ERP software. It also includes documents for compliance with GMP and FDA Title 21 CFR Part 11.

Validation Plan

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

Validation Plan@2x

Validation Toolkit Documents

Introduction & Roadmap to Validation

Master Validation Plan

Design Qualification (DQ)

Risk Assessment & Management

Vendor Qualification (VQ)

Development & QC Protocol

Hardware Specifications (HS)

Installation Qualification (IQ) for Install

Installation Qualification (IQ) for Upgrades

Operational Qualification (OQ)

Performance Qualification (PQ)

Support and Maintenance

SOP & Chance Control

Complying with U.S. FDA Title 21 CFR Part 11


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Contact Us

Datacor offers products and services designed specifically for process manufacturers and distributors. Contact us to learn more about our products and services. Call us now at (973) 822-1551 or fill out the form to the right.