Computer System Validation - CSV Consultancy

We conduct a comprehensive assessment of your existing computer systems to identify any gaps in compliance. This assessment involves a thorough review of system documentation, processes, and controls to ensure alignment with regulatory requirements.

Based on the assessment results, we work closely with you to develop a detailed validation plan and strategy. This includes defining validation objectives, scope, deliverables, and timelines. We consider industry standards and regulatory guidelines to ensure a robust and compliant validation process.

We assist in identifying potential risks associated with your computer systems and their impact on data integrity, reliability, and security. Our consultants employ risk assessment techniques to prioritize risks and develop effective mitigation strategies, such as risk-based testing and validation approaches.

We provide guidance on developing and improving documentation practices, including creating validation protocols, test scripts, and standard operating procedures (SOPs). Well-documented processes and procedures are crucial for demonstrating compliance and ensuring consistent system performance.

Our experienced consultants oversee the execution of validation activities, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) testing. We guide you through the testing process, ensuring adherence to protocols and best practices.

We assist in establishing robust change control and deviation management processes for your computer systems. This involves defining change control procedures, documenting change requests, assessing impacts, and implementing appropriate controls to maintain system integrity.