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FMEA Beyond the Form: Are You There Yet?
“What if one could travel briefly into the future, identify a forthcoming error, return to the present before it occurs, and intervene to prevent it?” That idea sits at the heart of risk analysis. To identify risks at the start and…
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User Requirements Specification — Getting the Sequence Right.
Most of us have written a URS with a system already in mind. The vendor had been shortlisted, sometimes already selected, and the document was drafted to formalise what had already been decided. The result is a URS that describes…
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The Illusion of Root Cause: 5 Whys in QMS
Most of us have used the 5 Whys during deviation investigations, but have we been using it correctly? It appears on every deviation investigation form, every deviation report, every post-incident review. Five questions. Five answers. Signed and filed as a…
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Factory Acceptance and Site Acceptance Testing: Accelerating Equipment Qualification with ValDoc Pro
Synopsis: “Suitable for the intended purpose/activities” is a core regulatory expectation for all pharmaceutical manufacturing equipment, and qualification is the documented proof that this is achieved. The qualification lifecycle starts with a User Requirement Specification (URS) document followed by a…
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Who is actually Responsible for the URS?
Synopsis: Before purchasing an equipment, software or instrument, regulatory requirement mandates that one documents what is expected of the proposed acquisition. While it may be tempting to rely on vendors for this, as they understand their product, they do not…
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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…
