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Modernizing biotech compliance: Inside the transformation of enterprise validation systems

In the highly regulated world of life sciences, quality isn’t a box to check—it’s a business imperative. For global en ...
JD Supra

FDA’s Draft Computer Software Assurance Guidance Changes the Game for Quality System and Production Software Validation

On September 13, 2022 the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...

3 Day Computer System Validation (CSV) Training Boot Camp: Identify the FDA's Current Concerns and How to Ensure Your Systems Will Meet Their Expectations (ON-DEMAND COURSE)

The market has opportunities in comprehensive training for computer system validation, particularly in regulated industries. Key areas include mastering FDA regulations, agile vs. waterfall ...
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Gilead's validation overhaul sets new biotech compliance benchmark

Major compliance overhaul: Gilead revamped core validation procedures, shifting to a risk-based approach that reduced redundancy and streamlined approvals. Next-gen systems rollout: A global Quality ...