Information Technology Compliance (Validation)
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.
THINQ combines a proven methodology based on ISPE's GAMP4 enhanced with the unique TCM (THINQ Compliance Manager) software.
THINQ delivers:
 A validation plan including risk assessment
Functional Requirements
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
|
