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Ofni Xprt Industry Services
4 services found
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 ...
by:Ofni Systems Inc. based inRaleigh, NORTH CAROLINA (USA)
Computer system validation (sometimes called computer validation or CSV) is the process of documenting that a computer system meets a set of defined system requirements. Validation of computer systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records is a critical requirement of electronic record compliance, as described in the ...
by:Ofni Systems Inc. based inRaleigh, NORTH CAROLINA (USA)
As the FDA increases regulatory enforcement of 21 CFR 11, one of the most difficult things for many companies is to know what their computer systems require to be in compliance. Ofni Systems can quickly assess all of your software, databases, and computer systems and identify what issues need to be addressed for ...
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 a detailed summary ...