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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