Tim Donelon, pharma serialization quality expert

Meet Tim Donelon, VP of Quality and Validation

With more than 17 years of experience in the pharmaceutical, biopharmaceutical, and medical device industries, Tim Donelon’s resume is as impressive as it is laser-focused. Skim through it even briefly and one theme quickly emerges: validation.

“I actually began as a chemist,” he says, “where I worked for a number of years testing over-the-counter pharmaceutical products like aerosols, gels and creams, transdermal patches—that sort of thing—for uniformity, content, and impurity levels. So right from the very start, validation was front and center.” He laughs. “And I guess I found it interesting, because I’ve been doing the same basic thing ever since.”

But even at that early juncture, Tim recognized the power and potential of computer systems validation within the life sciences space, prompting him to trade his lab coat and pipettes for a computer keyboard and screen.

“In my next job,” he continues, “I evaluated third-party software applications for Title 21 CFR Part 11 compliance (the federal regulations code established by the FDA regarding electronic records and electronic signatures), writing, executing, and summarizing supplemental ERES testing modules with respect to audit trails, electronic signatures, data archiving and restoration, and so on.”

As Tim dove deeper, one thing became clear: computer-assisted validations were here to stay. He subtly changed his professional and philosophical focus, with profound and lasting effects. “Quality is key,” Tim emphasizes. “I mean, at the end of the day, none of these regulations are really prescriptive. They don’t say how to do it, just that you have to comply.

“In a very broad sense, you could argue that the regulations themselves haven’t changed all that much. It’s just the implementation that’s different. And the key to implementation is quality management. That’s where the value comes from. Compliance is just the beginning. Anyone can do that. How do you deliver a quality product? How do you turn compliance into a frictionless user experience? How do you add value? Those are the key questions.”

For the last decade or so, that’s been Tim’s wheelhouse. Sure, the clients have changed. The exact validation processes and systems have all been a little different, but the bottom line is the same. Tim’s deep and broad understanding of the life sciences sector and pharmaceutical vertical has helped dozens of companies—from pharmaceutical companies to medical device manufacturers—meet the complex array of U.S. and global regulations.

Now, Tim brings his considerable talents, experience, expertise, and insights to Verify Brand. And he’s as excited to be here as we are to have him on board as our director of quality and validation.

“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. But there’s so much room to grow, so much more it can do. This is a quality platform that makes it easy to produce quality deliverables, across the board, throughout your organization.”

Come see for yourself. Drop Tim a line and he’ll share a demo of our best-in-class serialization and traceability software. We don’t know anyone better than Verify Brand to help you and your organization extract quality and value through the seamless implementation of our serialization and traceability platform.


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