Validation

Computer Systems

Drug manufacturers increasingly rely on automation, yet inadequate validation of control systems is still one of the most common sources of FDA 483 findings. Ensuring data integrity and security according to 21 CFR Part 11 is also an area of scrutiny for FDA auditors.QSP’s proven risk-based approach to validating computer systems emphasizes the most critical functions while ensuring the entire system is under control.

The engineering professionals at QSP are well versed in GAMP4, GAMP5, ASTM E2500-07 and other industry standards. QSP can validate any size system from a single PLC up to large DCS systems.

QSP works closely with your team to ensure that automation control systems are designed and installed according to your process requirements. We are proficient at developing and conducting risk assessments that result in complete Functional Requirements Specifications (FRS) and test protocols that challenge established tolerances. Our staff has applied experience that is well suited to helping you establish a validated state for your process control system.

Our team can help you validate both new and in-service PLCs, HMIs, networks, enterprise platforms, MES and other systems through the development and execution of:

• User Requirements Specifications (URS)
• Functional Requirements Specifications (FRS)
• Software Requirements Specifications (SRS)
• Part 11 Gap Analysis
• Risk Assessments
• Factory and Site Acceptance Tests (FAT & SAT)
• Validation Master Plans