At MedTech CSV, we provide end-to-end Audit Support and Training to help organizations achieve regulatory compliance and maintain a state of audit readiness at all times.

 

✅ Audit Support

 

We assist companies in preparing, managing, and responding to audits by regulatory agencies, clients, or internal quality teams.

•Gap Analysis & Mock Audits – Identify weaknesses before inspections.

•Audit Documentation Review – Ensure SOPs, validation protocols, and reports meet compliance.

•Vendor & Supplier Audits – Evaluate third-party systems and services for regulatory adherence.

•Regulatory Audit Readiness – Prepare for FDA, MHRA, WHO, or EU GMP inspections.

•CAPA Implementation – Corrective & Preventive Action plans for identified gaps.

 

📌 Example: Pre-inspection audit of a Laboratory Information Management System (LIMS) for 21 CFR Part 11 compliance.

 

⸻

 

✅ Training Services

 

We provide structured Computer System Validation (CSV) training tailored to your team’s roles and responsibilities.

•Awareness Training – Basics of CSV, data integrity, and regulatory expectations.

•Role-Specific Training – IT, QA, QC, Production, and Management focused sessions.

•Regulatory Training – GAMP 5, 21 CFR Part 11, Annex 11, and Data Integrity.

•Practical Workshops – Hands-on sessions for writing & executing IQ, OQ, PQ protocols.

 

📌 Example: Training QC analysts on audit trail review and compliance with FDA guidelines.

 

⸻

 

🌟 Why Choose Us?

•Expertise in FDA, MHRA, WHO, and EU GMP audit requirements.

•Customized training programs based on your system and industry.

•Support from audit preparation to post-audit CAPA closure.

•Blended approach: classroom + on-site + online training.