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Continued Process Verification (CPV) was never meant to be a “check-in-a-box" exercise. At its best, CPV is a living confirmation that a process remains in its v...


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In the data-driven world of life sciences, quick and reliable access to accurate data is essential. Yet many companies still rely on physical logbooks that require storage, upkee...


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The delay usually looks minor on the schedule. A cleaning validation report is still “with QA,” a protocol is “waiting on one signature,” and lab results are “almost ready.” Product...


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Quality by Design (QbD) is the dominant framework for robust, science- and risk-based process development in the (bio)pharmaceutical industry, especially in an era where pro...


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Commissioning, qualification, and validation (CQV) have always been the guardians of product quality and patient safety. Yet as life sciences organizations accelerate ...


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