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From Qualification to PPQ: The Bigger Picture of Paperless Validation
When organisations discuss paperless validation, Computer System Validation (CSV) is almost always the first topic on the table. This comes as no surprise — electronic hardware and software have become deeply embedded in every facet of modern manufacturing. Yet, while…
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GAMP 5 Software Categories
GAMP 5 is one of the most effective frameworks that help validation teams ask the right questions first. Modern pharmaceutical validation is no longer built around documenting everything equally. Whether following traditional Computer System Validation (CSV) or the more recent…
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Instrument Classification: Why One Qualification Strategy Doesn’t Fit Every Instrument
Every pharmaceutical QC lab relies on a diverse range of analytical instruments, from simple glassware to sophisticated analytical systems that incorporate sophisticated electronics and even a configurable software. As new instruments are procured, a fundamental question arises: Does this instrument…
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Equipment Classification: The Decision That Drives Qualification
Before an equipment qualification protocol is drafted, here’s a question worth asking: Does every piece of equipment have to go through a qualification lifecycle requiring the same resources, time, and effort, or would commissioning suffice for some? Some never pause…
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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…
