Computerised system validation (CSV) is critical in regulated industries like pharmaceuticals, medical devices, and biotech. It ensures that computerised systems are compliant with guidelines and capable of consistently producing high-quality products and data.
A key component of the CSV process is CSV auditing. CSV audits examine and evaluate computerised systems to determine if they have been properly validated and maintain their validated state throughout their operational lifetime.
Why CSV Auditing Matters?
There are a few key reasons why regularly performing thorough CSV audits is so important:
- Regulatory compliance – CSV audits provide evidence of compliance with regulations like GAMP 5, 21 CFR Part 11, etc. This protects companies during regulatory inspections.
- Data integrity – Audits verify that data handled by computerised systems remains complete, consistent, and accurate. This ensures reliable data.
- Quality assurance – Audits confirm that systems are validated and working as intended. This minimises risks and assures product quality.
- Best practices – Audits identify areas that need improvement or
corrective actions to follow industry best practices. This improves overall systems.
Overall, CSV auditing provides enormous value by confirming that computerised systems adhere to guidelines, maintain data integrity, and promote quality.
Planning for a Successful CSV Audit
Proper planning is crucial for executing effective and efficient CSV audits. Rushing into a CSV audit without thoughtful preparation can compromise the quality of the audit and the validity of the results. Here are some key planning steps:
Define Audit Scope
First, clearly define the scope of the audit. Determine which computerised systems, applications, infrastructure, processes, etc. will be included. The scope should be based on criticality, past issues, and known risk areas.
Assemble Audit Team
Identify auditors with the appropriate qualifications, training, and experience performing CSV audits. Include IT auditors and subject matter experts from quality assurance, manufacturing, etc. Make sure roles like lead auditor are assigned.
Develop Audit Schedule
Create a detailed schedule for the audit, including activities like planning, document review, on-site assessments, stakeholder interviews, findings analysis, and reporting. Build in sufficient time for a thorough audit.
Gather Necessary Documentation
Well before audits begin, collect all relevant documentation like system validations, OQ/PQ protocols, SOPs, change controls, previous audits, etc. This evidence supports audit findings.
Conduct Risk Assessment
Perform a risk assessment based on factors like audit history, system complexity, and criticality. This focuses on auditing high-risk areas and determines audit sampling size.
Solid planning is indispensable for effective CSV audits. It sets audits up for success starting from the initial stages. In upcoming posts we’ll cover executing, reporting, and following up on CSV audits.
Read also: Difference Between CSV and CSA
Resource Person: Joseph Turton