Quality that means business

What is intelligent quality and how does it impact your business?

Section 1

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.

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

Mike Butler

Founder & CEO at Unit Life Sciences

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.

Section 2

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.”

Section 3

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.

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

Janet Woodcock

M.D., Director at Center for Drug Evaluation and Research

Section 4

What is the ROI of intelligent quality?

Efficiency will undoubtedly be the most immediate and pervasive benefit of implementing an eQMS, but the potential for ROI extends far beyond cost savings. Read this blog to discover five areas where quality leaders have reported business impact after implementing an eQMS.

Life sciences companies are seeing rapid ROI after implementing ZenQMS to manage their documents, training, audits, and issues.

We’ve been able to reduce on-site audit time by more than 50% because we are able to provide auditors access to review documents in ZenQMS.

Jason Bissey

Director of Quality Assurance at Xerimis

Read the Case Study

Is your business on the path to intelligent quality maturity?

Our free guide can help you discover how a mature QMS drives quality across three dimensions: your people, your process, and your technology.

Get this guide

Why choose ZenQMS?

The right quality management solution is fit for purpose. Quality management isn’t all or nothing – manual systems vs. crazy complicated “enterprise software” is a false choice. ZenQMS offers purpose-built, life sciences-focused software as a service (SaaS) eQMS that is:

Right-sized and affordable for emerging biopharma and medical device companies
Equally appropriate to manufacturing partners
Fully compliant with key FDA and other regulations
Faster and simpler to implement than any traditional enterprise solution
Easier to administer and support, without the need for costly training
Optimized to rapidly and cost-effectively scale with your needs as you grow to hundreds or thousands of employees

The right quality management solution is fit for purpose. Look for a solution that’s cost-effective to implement with the functionality you need now, but that can scale up as your needs become more complex.

Ed Morris

Managing Partner at The Morris Group

Unlock intelligent quality for your business

Harnessing the capabilities of ZenQMS’s digital platform, life sciences companies can achieve the benefits of intelligent quality:

Expedited time to market for new products

Reduced risk

Greater internal efficiency

Stronger commercial readiness

Get new drugs to market faster

ZenQMS helps life science companies to be more responsive and efficient in advancing their scientific discoveries through regulatory approval, reduces risk, and streamlines the path to commercialization for new products.