Data Reliability and Regulatory Readiness

“The fundamental reality here is that if you've got questions about your data, a question like ‘Is there a co-eluting peak?’, you can't ask a question like ‘Is there a relationship between this structure, this modification, and the biology or the function?’”

— Erin Chambers, Global Vice President & General Manager, Consumables & Lab Automation, Waters Corporation

Erin Chambers, global vice president and general manager of Waters Corporation's consumables and lab automation business, ties data reliability directly to how far researchers are willing to push a scientific question. If a scientist is still uncertain whether a signal in their data is real or a coeluting artifact, she says, they cannot move on to ask a more consequential question about structure, modification, and biological function, a dynamic she sees playing out most acutely in biopharmaceutical development.

Asked how much of product development is shaped by anticipating regulatory demands versus responding to what scientists need today, Chambers says the two are not separate priorities: development is rooted first in direct customer conversations, but regulatory readiness is built into Waters products from the outset rather than added afterward. That reliability, she says, is what underpins the company's approach to regulatory readiness more broadly. Rather than treating compliance as a separate track, she describes it as built in through rigorous batch-to-batch testing and reproducibility standards, work that has led Waters columns to be specified directly into GLP-1 analytical methods. She points to impurities that can differ by a single atom or spatial arrangement as an example of the precision required, and frames the goal as consistency: getting the same answer every time, not just once. That focus on a dependable outcome, rather than a single data point, is what she says gives Waters products built-in readiness even before formal guidance catches up—readiness she describes as earned through testing history rather than added on at the last stage of development.

Chambers answered the following questions:

• You talk about reliable data as a precondition for scientific courage — the idea that researchers can only ask bolder questions when they trust their results. Where do you see that dynamic playing out most acutely right now in biopharma development?
• How much of your product development process is now shaped by anticipating what regulators will require, versus what scientists are asking for today?
• How do you build that regulatory requirement into the column, when potentially that guidance isn’t written yet?

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