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.

Specifically, QASI pursues three concrete goals.

First, the ACRES Audit Franchise. This project 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

Second, driven through the ACRES model of sharing best practices, off-the-shelf solutions, systems and processes, the Quality Risk Management (QRM) and Quality by Design (QbD) approach is being advanced. To deliver on this goal, ACRES is supporting an alliance of small and medium sized companies in developing and implementing with minimal capital investment state of the art processes enabling QRM and QbD. Together with the European Forum for Good Clinical Practice (EFGCP), a practical workshop is scheduled for June 2014 in which experienced QRM & QbD experts will discuss practical implementation steps and share their insight with “newcomers”.

Third, ACRES is developing a partnership with a project lead by Professor Hafen of the Swiss Federal Institute of Technology (ETH-Z) in Zurich that is developing a patient-centric EHR (electronic Health Record). This approach, much like a Swiss bank account for health information, puts patients in full control of their health data and does not expect them to relinquish any of their direct control to un-trusted third-parties. ACRES involvement in these efforts results from its potential to change the quality paradigm in critical areas such as pharmacovigilance and quality. Indeed, this EHR concept equates clinical research data (CRF data) with source data. This drives quality and efficiency, as transcription errors become a thing of the past and optimizing clinical trial oversight by enabling full remote monitoring . Monitoring acquires a completely new dimension: source data validation (SDV) truly becomes history.

This is just a start but these few changes signaling the beginning of a new era in quality and safety management.