GAMP Services

CSV & Data Integrity Audit

CSV audits examine and evaluate computerized systems to determine if they have been properly validated and maintain their validated state throughout their operational lifetime.

CSV & DI Audits identify any GAPS in the computerized systems performance & Its intended uses and regulatory requirements such as:

FDA 21 CFR Part 11
FDA 21 CFR Part 210/211
Eudralex and PIC/S Annex 11

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.

Analysis and System Remediation
Meets US FDA 21 CFR Part 11, EU Annex 11, PMDA ERES guidelines for 100% regulatory compliance
Process Consulting & CSV Process Harmonization and Optimization
Regulatory Compliance ,Templates, Checklists and Training
GxP Risk Assessment and Control Mitigation
ICH GLP / GCP / GMP Risk Assessments

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

Data Integrity Audit

Data Integrity Programs, Training, and Assessments

Data Integrity Training
Data Integrity Assessments for both electronic and paper processes
Development of data integrity programs, policies, and procedures
Data process flows
Data Integrity gap analysis of systems.

	303-304, Sahyog Elina, VIP Main Road Karelibaug, Vadodara – 390018 Gujarat, India.
	510-11 , Wind -A, 73 East Avene, Near Genda Circle, Sarabhai Campus, Alembic - Gorwa Road, Vadodara-390007.
	204, Navratna Corporate Park, ISKON - Ambali Road, Ahmedabad-380058.
	+91 9879594538

IT Group