Glossary
Verification of Implementation (VoI)
What is Verification of Implementation (VoI) in pharmaceutical industry?
Verification of Implementation (VoI) in the pharmaceutical industry refers to the process of confirming that corrective and preventive actions have been implemented as planned. It is a critical step in ensuring the effectiveness of quality management systems and addressing non-conformities. VoI involves providing objective evidence to demonstrate that specified actions, such as procedural updates, training initiatives, or process modifications, have been carried out as intended. This verification step is separate from the Verification of Effectiveness (VoE), which assesses whether the implemented actions successfully addressed the root cause of the issue.
What are the key objectives of VoI?
- Verify that equipment, systems, and processes have been installed correctly and are functioning as intended
- Ensure that all necessary documentation, such as SOPs, training records, and maintenance schedules, are in place
- Identify and resolve any deviations or issues prior to operational qualification (OQ) and performance qualification (PQ)
- Provide documented evidence that the system is ready for further validation activities
How does VoI ensure regulatory compliance
Verification of Implementation (VoI) plays a vital role in ensuring regulatory compliance by providing evidence that necessary actions have been executed. It confirms that procedures, processes, or systems are implemented as planned, aligning with regulatory requirements. VoI reduces compliance risks by identifying and addressing any deviations or gaps during the implementation phase. It ensures that corrective actions are not only planned but also executed, demonstrating a commitment to meeting regulatory standards. Through VoI, organizations can maintain the integrity of their quality management systems and build trust with regulatory authorities.
