Computerized Control System Validation
Computer System Validation
Computerized Control System Validation is the documented process of ensuring that the industrial technology (hardware and software) components controlling a manufacturing process are in conformance with the regulatory requirements overseeing that industry. This conformance is critical because it provides assurance that the manufacturing system and its processes are functional, secure and repeatable with consistent quality throughout the life cycle of the system.
Our projects in the healthcare, food & beverage, life sciences, and ,medical device manufacturing industries require IS engineers and management to maintain proficiency with FDA/GMP procedures and guidelines.
Our history of solutions, from the plant floor to the control room, combined with our years of validation development and execution experience make IS the perfect partner for our customers. Our team offers a comprehensive system validation strategy, as well as all of the associated documentation deliverables.
Standard Validation Development Activities:
- Conduct System Assessments, Qualification, Validation and Re-Validation Services
- Document Proper System Design, Functionality and Potential Vulnerabilities
- Align Client Documentation and Procedures with Validation Requirements
- Design, Develop & Execute Clear and Concise System Validation Documentation
- User Requirement Specifications (URS)
- System Requirement Specifications (SRS)
- System Detailed Specifications (SDS)
- Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) Protocols
- Control System Validation (CSV) Protocols
- Installation Qualification (IQ, OQ) Protocols
- Apply Change Control and Regression Testing when Validated Software and Hardware Alterations Are Required
