AN ISO 9001:2015 CERTIFIED
Company Connect Consultancy – Excellence in Validation
Computer System Validation - CSV Consultancy
Company Connect Consultancy (CCC) is a trusted provider of Computer System Validation (CSV) consultancy services, dedicated to helping regulated industries achieve compliance with industry standards and regulatory requirements. Our team of experienced consultants possesses in-depth expertise in the regulatory landscape and industry best practices. We collaborate closely with our clients to develop customized validation strategies that effectively address their unique operational needs and challenges.
Our CSV Consultancy Key Features
Compliance Assessment
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.
Validation Planning and Strategy
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.
Risk Assessment and Mitigation
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.
Standard Operating Procedures (SOPs)
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.
Validation Execution
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.
Change Control Management
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.
Ensure Compliance with Confidence
Request a Quote Today!
Partner with Company Connect Consultancy for expert CSV guidance, ensuring the integrity, reliability, and security of your computer systems. Our customer-centric approach helps you meet regulatory requirements while optimizing system performance and efficiency. Contact us today for a no-obligation quote!