Picture a hospital room where the attending nurse is preparing a patient for surgery, informing the person that his surgeon is OK — referring to his skill and expertise as a medical professional. The surgeon enters, exhibiting all the confidence and certitude of a cotton swab, he is even less effective at putting the patient at ease.
Of course, we recognize this as one of the anecdotal commercials for AT&T’s 5G wireless network, the message being “just OK is not OK.” The ad is part of a campaign featuring a variety of “professionals” who seem content with providing service that is just OK.
Jennifer Rodriguez, corporate quality systems manager for QuVa Pharma, finds the ads amusing, yet she has fully embraced the concept of just OK is not OK and instills it throughout her organization’s culture. QuVa Pharma is a 503B compounding facility with a large catalog of medicines, so anything less than optimal performance and the highest quality is not acceptable.
Rodriguez is well aware that the pharmaceutical industry is extremely complex and fast-moving — attention to every detail is vital. “If you miss a step, the impact on the medicine can be critical and result in affecting human lives,” she said.
For QuVa Pharma, delivering high quality products on time is the top priority. With an expanding catalog, the company set out to improve efficiency with testing processes and be more prudent with resources. To achieve those objectives, the organization implemented MasterControl Manufacturing Excellence™.
Generating numerous paper documents is common for regulated companies. With mountains of paper accompanying all the procedures across the operation, companies quickly become mired in labor-intensive processes. QuVa Pharma found itself in that scenario:
With these operating methods, QuVa Pharma did produce and deliver products. However, the company’s processes were still time-consuming. The organization was experiencing growth and the pressure was mounting to be more agile and function at market speed.
With a variety of processes and different methods of performing tasks, the MasterControl Manufacturing Excellence solution helped QuVa Pharma’s operation become more unified and efficient.
“The lab staff needs to track events such as system adjustments, suitability of the equipment and adjustments on results,” said Rodriguez. “It’s important to detect potential issues instead of waiting until the system fails. Having everything integrated is a big win. Tracking events and results and building forms is automatic. I have this resource where anything I need to find is just a click away. Also, If I have a notification step for someone, it’s immediate. How are you going to do that on paper?”
The U.S. Food and Drug Administration’s (FDA) current Good Manufacturing Practices (CGMPs) mandate that companies using software in the development of pharmaceutical products are required to demonstrate that their system is validated. Anyone who has been involved with validation knows it is a lengthy, arduous process with a lot of different areas to cover in order to meet the regulatory requirements.
QuVa Pharma happily turned over the validation heavy lifting to MasterControl. “When you’re in a highly regulated industry you have to demonstrate that your system is validated,” said Rodriguez. “Validation is tedious. Who wants to do validation? We provide compounding medicine, that’s our core. MasterControl complies with the validation requirements, so I don’t have to worry. This lets us focus on what we do best.”
By digitizing and fully integrating operational management systems as well as quality and documentation processes, QuVa Pharma significantly improved efficiency and productivity across the organization.
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