THINQ has been providing compliance services to Life Sciences organizations for the last 15 years to meet critical drug regulations including 21 CFR Part 11, GxP's, European regulations including MCA and EU/PiCS and Far East regulations including HSA and TGA.
A validation plan including risk assessment
Control procedures based on COBIT
Traceability and Linkage to Technical Design Documentation
Full test procedures (Installation and Operational Qualifications)
Project Management and reporting to FDA quality standards