Clinical Auditing

Clinical PV auditing is at times part of the required Good Clinical Practices or of Quality Assurance. We help recognize pitfalls in your PV system and suggest solutions in harmonizing PV systems. We understand that better planning is critical to the success of the product development and health and safety of the patient/consumer.

PV Audits ensure the effectiveness, operability and robustness of a PV system. It challenges its quality management system and assesses its claims. Good Practices and regular audits helps maintain the quality standards of both trials and services

Your expert for Clinical PV

MIVIGILANCE have experienced auditors that conduct unbiased audits and mock inspections to check your PV program and data needs. Our auditors checks regulatory GxP spectrum including GMP, GCP, GLP, GVP, General Data Protection Regulations (GDPR), Medical Device, and Computer System Validation. Our audits are thorough, including case intake, adverse events processing and submission, project management, data management, QPPV role and responsibilities, aggregate report writing, signal and risk management, clinical safety, etc.) and in accordance with EMA and FDA regulations, Standard Operating Procedure and work instructions.