10 Jul Meet our Validation Experts
Pharmaceutical serialization is a complicated subject. While pharma companies around the world are trying to grasp the business impacts of serialization and assemble their teams to meet U.S. and global regulatory compliance mandates, Verify Brand has been educating the industry about the importance of doing serialization right – especially the validation piece. Validation is such a critical step in your serialization implementation deployment. You simply can’t afford to get this step wrong.
The growing numbers of pharma clients that have selected our serialization software get not only the flexibility found in our single-tenant platform, they also gain the collective experience and assistance of our in-house validation team. As we have mentioned in previous posts, we pride ourselves on hiring the best and the brightest people. Today, we’d like to introduce you to Verify Brand’s double-smart validation experts.
Meet Tim Donelon, Vice President of Quality and Validation
Validation has been Tim’s passion for more than a decade, and for the past 12 months, he has been heading up Verify Brand’s quality and validation team. Over the years, his deep and broad understanding of the life sciences sector and pharmaceutical vertical has helped many companies successfully meet a complex array of U.S. and global compliance regulations.
Since he joined Verify Brand, Tim continues to educate pharma companies about the importance of a single-tenant platform, which is what initially attracted him to Verify Brand. “I was blown away by the Verify Platform,” he says. “You can’t sit through the software demo and not be impressed and even intrigued. From a pure compliance standpoint, it easily gets the job done.”
Verify Brand’s validation offering meets all compliance requirements and greatly reduces the effort required by our pharma clients to maintain a validated state. Our single-tenant platform allows our clients to control when upgrades are made to their environment so they can assess any changes before they’re made.
“But there’s so much more that the Verify Platform can do that goes beyond compliance,” Tim emphasizes. “The Verify Platform provides clients with powerful insights into their supply chain right at their fingertips in such an easy-to-use interface. I know that may sound like marketing ‘hype’, but Verify Brand has many clients outside of the pharma space that have been using this same solution for more than a decade to gain these insights, which have helped transform their business processes. We’re excited to provide our pharma clients with the same real-time insights and advanced analytics that will give them so much value beyond compliance.”
Meet Briana Johnson, Computer Systems Validation Specialist
Briana (pronounced Bry-anna) Johnson always knew she wanted to be in healthcare, but one essential requirement prevented her from becoming a hands-on practitioner. “I’m squeamish,” she says, “so I knew I could never be a doctor or nurse.” Instead, armed with a keen “science mind” and a bachelor’s degree in biology, she focused her sights on pharmaceutical research and development.
Briana’s college internships were spent working as a chemistry analyst performing routine Quality Control (QC) testing in a Good Manufacturing Practice (GMP) environment. After graduating, she transitioned from QC analysis to analytical drug development projects, and ultimately into laboratory management. Although she enjoyed lab work, she discovered what she really liked was the quality piece; when pharmaceutical products actually accomplish what they were created to do, peoples’ lives are positively impacted.
When Briana migrated from the laboratory to the quality assurance department, she realized it was a good fit for her personality. Her fine-tuned ability to focus and pay close attention to details are as second nature as breathing. In addition, she understands the importance of reviewing her own work for accuracy and then making sure other peoples’ also meet the prescribed standards.
“I’m very interested in keeping current with changes in the regulations and updating processes that keep our clients current,” she says. “It helps me learn a lot. Plus, I like teaching other people, as well.”
Although quality assurance processes generally follow a similar set of guidelines and principles, Briana thinks Verify Brand’s quality process stands apart in a couple of ways. “We take a lot more feedback from our clients and are willing to have an open dialogue,” she says. “Additionally, quality is highly involved throughout all aspects of our processes, from development through qualification.”
While Briana is the consummate rule-follower at work, outside of work, her hobbies are all about ditching the rule book.
“I love to cook, but I don’t follow recipes,” she says. “I skim the recipe and use only the parts I like. I want to have the flexibility to deviate from the recipe and be as creative as my imagination allows.”
Meet Brianne Aeikens, Quality & Validation Specialist
At first glance, it’s easy to see that Brianne (pronounce BREE-ann) Aeikens and Briana Johnson have many things in common. Beyond the similarities in their names, they have had an affinity for science and math since they were children, and learned at an early age to harness the power of focus.
In fact, one of her favorite things to do outside of work is to play golf, which Brianne has been doing since the age of three. “It’s a lifelong activity that also teaches you mental toughness,” she said. “You have a couple of bad holes, you have to shake it off and move forward.”
Brianne knew from an early age that she wanted to go into science or engineering. She figured after she received an undergraduate degree in biomedical sciences in 2014, she would go on to pharmacy school to pursue a Pharm.D. degree. However, Brianne wanted to take time off before getting an advanced degree and quickly discovered there were inumerable roles at biotech companies where she could put her science background to good use, first in the lab, then in the quality department.
Brianne is Verify Brand’s newest member of the validation team. Right from the start, she identified what sets Verify Brand apart from its competitors: Verify’s quality, software and solution architect teams work cross-functionally, and quality is integrated throughout the entire implementation process. “Involving quality assurance at each step of the way helps ensure that we’re delivering a high-quality product to our clients. It also means that we know what’s in the development pipeline and can prepare quickly to support client qualification of new releases. What I like about Verify Brand is that we’re providing a valuable service to our clients. They’re able to go live with their serialization implementation a lot more quickly by utilizing our skills and experience. That means the consumer can use these life-saving pharma products sooner.”
Now that you’ve met our validation team, let us walk you through the software and our SWIFT implementation framework Tim, Briana and Brianne are so passionate about.