In the pharma industry, many use regulatory inspection history and audit reports to get a feel for how a manufacturing operation is run from a compliance/quality standpoint. But TriRx believes these are just one of the many ways to gauge quality history, systems, and culture at an organization. Others include:
Inspection readiness
A company-wide quality first mindset
Transparency around regulatory inspections
How quality issues are resolved
In the latest article below, TriRx’s co-founder, Director, Executive Vice President, and Chief Operations Officer Jim Scandura and Executive Vice President, Quality Chief, and Chief Quality and Regulatory Affairs Officer Don Britt discuss the importance of quality systems at CDMOs and possible red flags of a suffering quality culture.
Moving Quality Forward
At TriRx, quality culture is a fundamental part of the company, not just a buzzword. Learn more about the importance and evolution of quality systems and quality culture.