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Demystifying GAMP 5 Software Classification: Understanding Categories 3, 4 and 5
Summary: In a GxP environment, the software to be acquired should be fit for use. In order to meet the user requirements, one buys software that can be used as-is, with configuration, or custom-developed. To ensure the appropriate documents are…
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One-Size-Fits-All Paperless Validation – Is It Really Fit for Use?
Synopsis: Popular validation tools have a basic flaw – these applications were designed to only carry out qualification activities. This article emphasises the differences between qualification and validation, and why for process and cleaning validation/monitoring, such “paperless validation” applications offer…
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Can AI help in Validation? Cutting Through the Hype
As interest in AI continues to grow, some vendors are promoting AI as tools capable of generating qualification deliverables such as User Requirement Specifications (URS), Functional Specifications (FS), and traceability matrices, with minimal human input. This article provides a grounded,…
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The ROI of eLog Pro: Not Just Financial Benefits for Pharmaceutical Manufacturers
This article explores how eLog Pro, Quascenta’s electronic GMP logbook software, helps pharmaceutical manufacturers to achieve GMP compliance and boost operational efficiency. It details the limitations of paper-based logbooks and shows how digital documentation improves data accuracy, reduces human errors,…
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Digitalization in Pharma: How to make the switch
Synopsis A robust digital ecosystem streamlines processes and improves data management in the pharmaceutical industry, but conflicting priorities can create disconnected software silos. Because digitization needs continuous investment, steady incremental progress is better than sporadic efforts. Success depends on strong…
