Facts & Mission

FACTS

Recent Warning Letters raise questions about the quality of oversight by sponsors and CROs.

FDA and Country Regulatory Authorities are increasing the concerns in regards to the clinical quality and as consequences the numbers of inspections also initiated by Regulatory Authorities are increasing importantly.

Many audits may occur but there always will be an inter-company/sponsor/CRO variation which may be consequence/interference of audit price, number of sites audited, selection criteria for site audits, number of days at each site audited, audit format and actions taken after the audit findings.

 
MISSION

Quality Plus mission is to oversight GCP quality and compliance activities providing recommendations for risk mitigation, continuous improvement and/or issue resolution, developing an overall risk assessment strategy and consistent execution of the risk strategy. Ensure that effective GCP quality processes and SOPs are in place for each functional area. Identifies gaps and issues to develop CAPAs and/or strategies to mitigate risks during and/or after inspections.