Assist with remediation planning and implementation to resolve issues identified in internal or external audits.
Change Control Support
Assist operating companies in reviewing proposed equipment or system changes and assessing impact on process or product quality. We can develop and execute appropriate validation tests to support the changes and document that the changes have been implemented consistent with cGMP expectations.
ATV has significant experience working with Manufacturing and Facilities personnel to meet aggressive Validation timelines with a minimum impact on Operation schedules.