Quality that means business

Mike Butler

If everyone in the company, including senior management, has a clear view of quality, then your entire company becomes more intelligent.”

– Mike Butler, Founder and CEO, Unit Life Sciences

What is intelligent quality?

Intelligent quality is achieved by businesses that are living the letter and spirit of their quality systems in the most efficient way possible. And for these businesses, quality becomes the basis for their reputation and serves as a competitive advantage in the marketplace. Risk management is embedded in every process and is a driving force in CAPA. Actionable intelligence is readily available and the leaders of the organization are empowered to make informed business decisions.

Companies that invest in intelligent quality will reap the business benefits inside and out.

COMPLIANCE

INTELLIGENT QUALITY

Reactive "box checking" culture
Quality and compliance embedded deeply in the company culture
Manual system for document management (SOPs, records, etc.)
Automated/intelligent system for document management, CAPA, training and change control
Manual spreadsheet-based systems for enforcing process (complaints, deviations, change control)
Process based on electronic forms and defined workflows; easily accessible dashboards and analytics
Inquiries/audits are painful and costly for everyone involved
Inquiries/audits are managed with ease
Procedures are not well defined or do not match actual processes
Procedures are managed, tracked and updated in a digital system
Patients are at risk; business is at risk
Patients benefit from better quality products and services; business risk is reduced

For companies in regulated environments, quality IS business. Hear from Panos Boudouvas, CEO of ZenQMS, and find out what that entails.

 

Why does quality matter?

Don’t take our word for it: Read the FDA’s recommendation for drug current good manufacturing practices (CGMP)

It is the role of management with executive responsibility to create a quality culture where employees understand that data integrity is an organizational core value and employees are encouraged to identify and promptly report data integrity issues. In the absence of management support of a quality culture, quality systems can break down and lead to CGMP noncompliance.”

Intelligent Quality Maturity: Driving Business Success

Don’t wait for a 483; find out today how your business will benefit from investing in an intelligent quality management system. 

Our free eBook explains:

  • Best practices and advice from regulatory and compliance experts
  • The importance of developing a culture of quality across your organization
  • The risks associated with a manual quality system
  • How to articulate the current state of your QMS to internal stakeholders and chart a course for continuous improvement

Intelligent Quality Maturity: Driving Business Success

Janet Woodcock

To help reduce drug shortages, we need manufacturers to sell quality – not just medicine.”

– Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research (2019)

Does quality save lives?

The answer is a resounding yes! 

Companies designing or manufacturing drugs or medical devices that will be used by patients require documentation around processes, workflows, outcomes, and changes. They also need documentation for which employees are trained, responsible, and accountable for those activities. The absence of those measures can introduce variability, result in noncompliance, and even lead to death. 

The FDA regulations are in place to safeguard the public from undue risks. They are not intended to slow down the process of bringing new drugs to market. Hence, the FDA preaches the importance of quality.

Percentage of Drugs Newly in Shortage by Reason