Computerised System Validation: Top 5 Common Pitfalls. Welcome to our comprehensive series on the pivotal area of regulatory compliance, specifically Computerised System Validation (CSV). The stakes in this complex terrain are high, with intricate regulations, expensive mistakes, and compliance requirements all posing business challenges.
Over the course of this blog, we’ll dissect the “Top 5 Common Pitfalls” that organisations commonly stumble upon in the CSV process, with a mission to help you sidestep these pitfalls and align your CSV process with industry best practices.
Understanding Regulations: Navigating the Computerised System Validation SV Maze
Feeling overwhelmed by the manifold regulations of CSV? It’s a common pitfall, like wandering a labyrinth without a roadmap. This map, representing the latest guidelines and requirements, can be your guide, helping to avert unexpected obstacles and detours in your compliance journey.
Resources like the OECD 17 on GLP principles and computerised systems, the OECD 22 on GLP data integrity, and the PICS Guide to GMP, among others, offer invaluable assistance to those lost in the GLP domain. Regular updates from these sources ensure your regulatory roadmap stays current and navigable. Here are some links to some invaluable resources:
OECD 17: Application of GLP Principles to Computerised System
MHRA: Guidance on GxP data integrity
PICS: GUIDE TO GMP FOR MEDICINAL PRODUCTS ANNEXES (Annex 11)
The Art of Risk Assessment: Managing Potential Issues
A pitfall on our CSV journey is bypassing the risk assessment step. Risk assessment is integral to the validation process, shedding light on potential issues that could negatively impact system performance or compliance.
There are several types of risk assessments you can apply to the CSV process. These include vendor risk assessment, system risk assessment, and Data Integrity Risk Assessment (DIRA). Through these assessments, you can manage risks effectively and facilitate decisions around system selection, testing scope, and compliance requirements.
Change Control: The Steering Wheel of CSV
Change control often falls by the wayside in CSV processes, resulting in the neglect of a crucial part of the journey. Consider change control as your CSV steering wheel—essential for keeping your system on track and in a validated state during validation and operational stages.
Whether you’re tracking system modifications during validation or ensuring system validity amidst operational changes, a solid change control process is indispensable. Remember, in a world where change is the only constant, it’s critical to have a GPS!
Documentation: The Key to Compliance
The fourth pitfall in CSV is improper documentation of the validation process. Detailed records of user requirements, test results, and system changes are crucial for compliance. When it comes to validation, “Good documentation is good business!”
Documents such as the Validation Plan, Risk Assessment, Requirements Specification, Design Specification, Test Protocols (IQ, OQ, PQ, UAT), Test Results, Validation Report, System SOPs, and Change Control Records collectively form the pillars of a robust CSV documentation system.
Effective System Testing: The Crucial Final Checkpoint
Insufficient testing is a final common pitfall in CSV. Comprehensive testing is a pivotal part of CSV, ensuring the system’s resilience across various scenarios.
There are multiple forms of testing in CSV, including Functional Testing, Integration Testing, User Acceptance Testing (UAT), Performance Testing, Security Testing, and Disaster Recovery and Backup Testing. The type and depth of testing depend on the validation process. Each test serves a unique purpose, ranging from ensuring functionality to verifying the system’s reaction under heavy loads or critical data handling.
Remember, CSV is a life cycle, not a one-off process. As your system evolves, so should your validation process. Keeping pace with changes will ensure you stay compliant. After all, an ounce of prevention is worth a pound of cure!
Embarking on the CSV journey might seem daunting, but with the right knowledge and resources, you can sidestep common pitfalls and confidently navigate the labyrinth of regulatory compliance. Stay tuned for more insights into the world of CSV!