Origin

Valoit was formed specifically to find innovative and efficient solutions for compliance with existing FDA regulations, to interpret the latest regulations, and to anticipate trends and developments in this ever-changing field. Our team has been extensively trained in Computer System Validation (CSV) strategies. We are proud of our successful relationships with a number of pharmaceutical, medical device, and diagnostics companies.

We value our relationship with our clients, hence our goal is to assist our clients in the development and implementation of complete CSV strategies that meet or exceed current regulations and industry standards. We do this by supplementing our client's staff with a team to handle the CSV responsibilities, thus not only providing our technical expertise, but also freeing the client's staff to perform their normal job functions. Our thorough understanding of the FDA's Good Manufacturing Practice (GMP), Good Laboratory Practices (GLP), Quality System Regulations (QSR), Electronic Records/Electronic Signatures, International Standards Organization (ISO), Software Engineering Institute (SEI), and Institute of Electrical and Electronic Engineers (IEEE) software development standards, combined with our unique application of technology, sets us apart.

What sets Valoit apart from other firms is that our staff is composed of experts with backgrounds in software development and documentation in regulated and mission critical environments. Our staff includes project managers, software developers, regulation specialists, regulatory researchers, technical writers, and documentation specialists. By employing a team approach, we are able to assign the best resources to each phase of the project. We work together with our client's experts to evaluate current procedures and systems and to provide improvements as necessary. At Valoit, we understand the rigors of the computer system development life cycle and work within its framework to ensure the successful completion of our projects.


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