Save Time and Money with Our Tools and Expertise
At the core of our services are validation scripts developed in accordance with cGMP guidelines in FDA regulations 21 CFR Part 11, Part 210, 211 and Part 820 and Part 58 to satisfy GAMP 5 guidelines. This comprehensive library of templates eliminates the need for our customers to develop their own templates and test strategies while facilitating test and trace requirements. Our template library significantly reduces validation costs and is a solid platform upon which to expedite deployments. Use of these templates assures compliance with the latest developments in 21 CFR 11, including the recent FDA move to a risk-based approach.