Compliance

Computer Systems Validation (CSV)
Logica Life Science's Computer Systems Validation Services (CSV) was formed specifically to find innovative and efficient solutions for compliance with existing FDA (Food and Drug Administration) regulations, to interpret the latest regulations and to anticipate trends and developments in this ever-changing field.

Our CSV consultants to the Regulated Industries have been extensively trained in CSV strategies. We are proud of our long-term relationships with a number of pharmaceutical and medical device companies. Our innovation and commitment, we have a proven track record of successful audits by a number of companies in these industries.

Because we value our relationship with our clients, 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 CSV 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 Fad’s Good Manufacturing Practice (GMP), Good Laboratory Practices (GLP), Good Clinical Practices (GCP), 21 CFR Part 11 - Electronic Records/Electronic Signatures and Institute of Electrical and Electronic Engineers (IEEE) software development standards.

The Logica Life Science difference what sets Logica Life Science apart from other firms is that our consultants are composed of experts with backgrounds in software development and documentation in regulated and mission-critical environments. 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. We understand the rigors of the computer system development life cycle and work within its framework to ensure the successful completion of our projects.