COMPLIANCE SERVICES
Companies operating under FDA guidelines require regulatory compliance focused on ensuring the safety and verification of the automated process functions across a myriad of environmental, industry and quality assurance regulations.

CPS provides compliance services for new or retrospective computer control systems, process automation and instrumentation projects. The full portfolio of compliance services we offer is comprised of:

• + Program and project management
• + Instrument calibration and calibration verification
• + Validation strategy development
• + Compliance gap assessments
• + Hazard analysis/Risk assessment
• + Installation, operational, and performance qualifications development and execution
• + Change control design and deployment

Compliance documents we create include:

• + Validation Master Plan and Schedule
• + IQ/OQ/PQ Protocols
• + 21 CFR Part 11 Assessments
• + User Requirement Specification
• + Functional Requirement Specification
• + System Design Specification
• + Safety Risk Assessment
• + Traceability Matrix
• + Summary Reports

Download this Compliance and Validation brochure (PDF: 360k) to learn more about CPS capabilities in this area.