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Achieve compliance with government regulations

Client Business Need: Achieve compliance with government regulations – Need documented evidence that software requirements have been implemented correctly as part of showing that systems comply with FDA regulations

Expertise leveraged: Computer system validation and life science industry knowledge.

STS Solution Credentials: We have led a variety of projects in the heavily FDA-regulated environment to establish documented evidence that software requirements have been implemented correctly and show that our clients’ systems conform to federal regulations. Using our services, clients are able demonstrate that their manufacturing, laboratory, and clinical systems meet the critical compliance regulations for security and integrity, and that they were structured to be easily audited as required by law.