ICH Q10 recommends that Management Reviews are performed in order to provide assurance that process performance and product quality are managed over the lifecycle. The Management Review process should include the results of regulatory inspections and other audits, measures of customer satisfaction such as product quality complaints and recalls, conclusions of process performance and product quality monitoring and the effectiveness of process and product changes.

PSC can help you structure the Management Review process to ensure that your senior management team is appraised of your quality system in a concise and expeditious manner Specifically we can assist you:

• Structure a concise, comprehensive and effective review process including areas to be addressed, documents required, effective presentation format, and documenting and tracking action items as a result of the review.
• Address regulatory inspection observations and other audit findings including liaison with regulatory bodies and recommendations for remedial actions.

If you have a need for our Management Review services, please Contact Us.