Case Study
How Modernising Operations Gave QuVa Pharma a Stronger Competitive Edge in the Pharmaceutical Market
As part of its continuous improvement program to drive additional growth and increase efficiencies, QuVa Pharma sought to optimise its testing processes — aligning lab operations and quality efforts to maximise resources and minimise paper-based processes.
Jennifer Rodriguez, Corporate Quality Systems Manager, spoke about how using the MasterControl Manufacturing Excellence™ solution in the laboratory has significantly improved process throughput, employee proficiency, cross-functional team collaboration and quality
Focus:
503B Steril Compounding
Headquarters:
Sugar Land, Texas
Employees:
721
Quality Professionals:
135
Improve testing efficiency, optimise and enhance alignment with lab operations and quality, make more efficient use of resources and eliminate paper-based processes.
Digitising and fully integrating operational management systems as well as quality and documentation processes resulted in more streamlined operations and better efficiency across the organisation.
No Margin for Error
In the pharmaceutical industry, mistakes can be costly, increase waste and create unnecessary inefficiencies that decrease productivity in the organisation.
“ If you miss a step, the impact on the medicine can be critical and result in affecting human lives.
Corporate Quality Systems Manager, QuVa Pharma
QuVa Pharma’s potency test processes were an area where the organisation saw an opportunity to leverage technology to decrease manual steps, improve throughput and improve right-first-time metrics.
1
Lab staff relied on a paper-based documentation system that required manual cross referencing with previous records.
2
Paper documents were scanned in order to file them electronically. This created an extra step, which increased the time needed to complete processes.
To detect missing steps or calculation errors, quality assurance had to verify each one of the steps. This added more tasks to the processes, which was an inefficient use of resources.
“ In terms of operation, look at the amount of time you waste because of paper and duplicated efforts. If your company wants to grow, there is no space for paper. It’s not sustainable.
Corporate Quality Systems Manager, QuVa Pharma
“Reducing steps and manual interactions in a process is the best way to focus on making improvements at the outset versus trying to solve issues later.”
How Digitisation Led to More Efficient Operations
With the objective to improve test efficiency, QuVa Pharma implemented MasterControl’s Manufacturing Excellence solution. The company immediately saw improvements in multiple areas:
1
Enhanced business function and system integration.
2
Records and all other documents are in electronic format, making referencing and reviewing quicker and easier.
3
Corrections and accountability are clear, which helps staff move reports through all the testing stages faster.
4
Manual and redundant steps are significantly reduced.
“The system tracks everything and will not allow incorrect, missing or out-of-spec entries. The best way to eliminate errors is to make it impossible to make them in the first place. That’s the quality approach.”
Aligning Lab Operations and Quality
QuVa Pharma set out to shift from paper-based and hybrid processes to a fully digitised operation. MasterControl Manufacturing Excellence enabled the organisation to:
1
Fully integrate management systems.
2
Improve efficiency with reporting and all other document-related tasks.
3
Eliminate inefficiencies and duplicated efforts common with paper-based processes.
4
Substantially improve functional coordination.
Since QuVa Pharma implemented Manufacturing Excellence, quality and operations have an optimised and enhanced alignment, which increased right-firsttime product outputs.
“ Having everything integrated is one of the biggest wins with implementing Manufacturing Excellence
Corporate Quality Systems Manager
QuVa Pharma
Implementing Manufacturing Excellence During the COVID-19 Pandemic
The social distancing mandate imposed during the COVID-19 pandemic changed the dynamic of workforces in every industry. Companies across the globe needed to maintain business operations with employees working remotely. During the lockdown, QuVa Pharma was in the middle of implementing the Manufacturing Excellence solution.
“The big question was, how are we going to implement this project if we cannot see one another?”
QuVa Pharma successfully implemented the Manufacturing Excellence solution in a virtual working environment. The staff and MasterControl teams involved in the project completed everything remotely using cloud technology. Every process from user requirements through go-live was done remotely.
“With COVID-19, the benefits of Manufacturing Excellence are even more clear. Instead of having face-to-face conversations, we need to automate processes as well as share information, collaborate and get approvals remotely. Having a system that allows us to do that is critical.”
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