Validation Protocol / Reports / Field Execution

Validation Protocol / Reports / Field Execution

Bfresh works intimately with clients to develop quality validation protocols and reports. Our protocols include custom-built validation approaches and methodology with clearly defined, pre- established acceptance criteria. We can serve you with the clarification of regulations in determining the validation requirements, manage fulfillment of methodologies, and prepare necessary reports. We furnish speedy documentation and can schedule validation projects with short lead times. We use a realistic integrated approach to commissioning and validation activities – ensuring complete 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.

Our validation approach is based on current GMP, GLP, EU, ISO, and 21 CFR Part 11 regulations. Our professional staff will ensure that protocols are written and executed according to user requirements, specifications, applicable regulations, and SOPs.