|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.