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