Preparation for ‘mock’ audits and recommended Corrective and Preventive Action (CAPA)

Pharmacovigilance audit activities shall verify, by examination and evaluation of objective evidence, the appropriateness and effectiveness of the implementation and operation of a pharmacovigilance system, including its quality system for pharmacovigilance activities.

• Strategic level audit planning resulting in an audit strategy (long-term approach), which should be endorsed by the top management.

• Tactical level audit planning, resulting in an audit program for setting audit objectives and the extent and boundaries (often termed as scope) of the PV audits and inspections in that program.

• Operational level audit planning, resulting in an audit plan for individual audit engagements, prioritizing audit tasks based on the risk, utilizing risk-based sampling and testing approaches, reporting audit findings based on the relative risk level, and offering audit recommendations per the suggested grading system.

• We, IGRS shall provide the end-to-end support for the mock audits. Our experts can audit the Pharmacovigilance system for its completeness before the Agency Inspections if any.

• The assistance in the corrective and preventive actions shall be provided by team of experts at IGRS customized for each client as per their needs.