We have experience in validating a vast array of GCP, GLP and GMP systems. In
addition, we assist our clients in meeting the requirements mandated by the Code of
Federal Regulations, especially those prescribed in 21 C.F.R. Part 11. Our skilled
team will gather your user requirements and assess your system, to ensure that it is
designed and tested to operate as intended. For those whom are unfamiliar with
computer system requirements and/or are new to operating in a regulated space,
we will create a validation project plan that will guide you through every step of the
regulatory process; from designing User Requirement Specifications, through
authoring Validation Summary Reports, and into production.