Refine by
Ofni Method Validation Services
2 services found
by:Ofni Systems Inc. based inRaleigh, NORTH CAROLINA (USA)
Method validation is the documented process of ensuring a test method or assay is fit for its intended purpose. Regulatory guidelines dictate that analytical test methods used during drug discovery, development, and production will be validated and that validation activities will be summarized in ...
by:Ofni Systems Inc. based inRaleigh, NORTH CAROLINA (USA)
Process, Design, and Equipment Validation are the formal processes for establishing objective evidence that systems consistently produce results or products meeting predetermined specifications, as required by the Federal FD&C Act and cGMP. Validation is an excellent tool to understand and maximize value from your business processes. Validation is also a compliance issue; the FDA requires ...