Since the mid-1980's GxP (GMP, GLP, GCP) Regulated Industries have been required to provide evidence and associated documentation that their computerized systems have been developed according to quality software engineering principles, and that each system provides the functionalities required by its users, and they will continue to do so over time. Due to these regulatory requirements, companies have had to expand their resources to ensure that computerized systems are fully validated and comply with the GxP regulations.
Xyntek's experience in developing GxP compliant Computer System Validation (CSV) protocols and the application of strict software development life-cycle procedures represents a valuable resource for your validation team. Xyntek's professionals have been trained to make validation and compliance an integral part of their technical development process, which ensures that the computer based systems we develop will meet the necessary qualifications in an efficient and timely manner.
Xyntek's Compliance Services include:
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