PSC works closely with clients to develop quality validation protocols and reports. Our protocols include customized validation approaches and methodology with clearly defined, pre- determined acceptance criteria. We offer fast documentation turnaround and can schedule validation projects with short lead times. Principle benefits include reduced cost and time to achieve a compliant system. We use a pragmatic, integrated approach to commissioning and validation activities – ensuring sound documented compliance with cGMP for all our assignments. We offer full validation services associated with manufacturing projects and offer services to retrospectively validate existing manufacturing processes. We can assist you with the interpretation of regulations in determining the validation requirements, manage implementation of methodologies, and prepare necessary reports.
Our validation approach is based on current GMP, GLP, GAMP 5, ISO, and 21 CFR Part 11 regulations. Our experienced staff will ensure that protocols are written and executed according to user requirements, specifications, applicable regulations, and SOPs. We provide versatile services that include:
- Protocol Generation
- Protocol Execution
- Final Report Preparation
- Quality Review
If you would like more information, get in contact with us directly here.