Although the responsibility of investigating product complaints generally falls within the Manufacturing or Product Quality business unit, life science companies are required by law to report any product complaints to regulatory authorities if there is an associated adverse event or serious adverse event.
The absence of a detailed adverse event evaluation in product complaints often causes serious audit findings, warning letters or even millions of dollars in fines from regulatory agencies.
A large part of the problem is that in most pharmaceutical companies, the safety system and the quality management system are not integrated – both the technology and the processes are completely separate. This lack of integration introduces a tremendous amount of regulatory and financial risk to the company.
During this webcast, Anjani Jha, Senior Director of November Research Group and Dave Hess, Solutions Consulting at Sparta Systems discuss how pharmaceutical companies can leverage and integrate advanced quality management and pharmacovigilance solutions to deliver immediate value into a company’s business process.
Topics include:
- Challenges that life science companies face when running separate safety and quality management systems
- What an integrated system looks like
- Benefits of integration with tangible results