Quality Assurance Systems Initiative (QASI)
The Quality Assurance and Safety Initiative (QASI) addresses a systemic weakness in the quality approach of the clinical trials and drug development enterprise: silo thinking and silo mentality with no sharing of quality-related information.
Informed by experience of other industries such as the airline industry that utilizing a trusted partner—in the case of air transport, IATA—is a reliable mechanism for developing and successfully implementing a culture of sharing quality data and “error reports”. Air transport has been doing this for more than 70 years. In our industry—with the exception of the GMP area for API and inactive ingredient suppliers—this is still an alien concept. Through QASI, ACRES and its multiple stakeholder Allies will change this.
The ACRES Audit Franchise leverages audit and CAPA (Corrective and Preventive Action) related information generated by a multitude of stakeholders in the clinical trials and drug development space. The ACRES Audit Franchise will:
- Enable sponsors to plan audits
- Allow sponsors to tender audits that they intend to outsource
- Allow auditors to submit a proposal to potential sponsors
- Identify a roster of “ACRES registered” auditors
- Confirm the competency of “ACRES registered” auditors through its roster of highly recognized QA and auditing experts
- Substantiate this competency of “ACRES registered” auditors over time
- Share audit outcomes from performed audits
- Share CAPAs from these audits
- Generate periodic summary reports on audit findings trends
Recognizing that quality is the essential common element to all process improvement initiatives, the global standard recently published by ACRES and the British Standards Institution provides a framework for a culture of quality across the enterprise. This signals the beginning of a new era in quality and safety management for clinical research and drug development.