CCTech use the V model risk based approach to validation (as illustrated below). We are well versed in the development of test protocols; either internally or in consultation with equipment and system suppliers to ensure that protocols are developed to meet with the project and regulatory requirements.
CCTech are focused on projects governed by regulatory compliance and that require a structured approach to delivery, running through the project from design inception to handover. This life cycle validation from URS, VMP, DQ, IQ and OQ require an understanding of the science, research and process and not just the mechanical parts and build components.
From high specification aseptic facilities, cleanrooms, specialist containment and other regulated facilities, we offer compliance to cGMP and cGLP standards to meet the stringent expectations of the regulatory bodies.
With experience of delivering licensed facilities for the MHRA, HSE, FDA, Home Office as well as other regulators.
This includes recommending and implementing validation approaches that meet the regulatory body’s expectations.
We have experienced Validation Engineers and consultants that can bring many years’ hands on validation experience to your projects.