From CSV to CSA: How Change Visibility Simplifies Validation
For years, validation in regulated labs has been shaped by a simple instinct: test everything, document everything, leave nothing uncovered.
That mindset made sense in the early days of digital adoption. As labs moved from paper records and spreadsheets into software-driven workflows, regulators needed assurance that computer systems would not compromise product quality, patient safety, or data integrity. That gave rise to Computer System Validation, or CSV.
But today, many labs are asking a fair question: if software vendors are already validating their platforms, and if not every feature carries the same level of risk, why are teams still spending months retesting everything? Conversations with industry leaders, including Scott Krieger, Quality Director at Labbit, highlight how common this tension has become–and how urgently labs are looking for more practical, risk-based approaches.
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