Two men in conversation in a laboratory or research facility, reviewing a document. One man is pointing at the document, while the other listens. There are large scientific machines and equipment in the background.

ISPE GAMP 5 support at any stage of your project

Some teams come to me before a project starts. Others come mid-project, when scope has drifted and documentation has fallen behind. A few come when a project has stalled at FAT.

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What I offer

SGP Quality Engine implementation

  • Full implementation of the model in your organisation

  • Covers project model, Stage Gate process, SQP setup, and full template structure

  • I stay until your team can run it independently

You end the engagement with a well-defined process and a set of templates your team owns.

Advisory and project support

  • Advice at any phase of a project

  • Direct support at early specification, design freeze, and final verification, where risk is highest

  • Specific recommendations based on what I see in your project

You get a clear picture of what’s missing and a prioritised plan to address it.

Training

  • Workshops on intended use definition, fail-safe design, Stage Gate, and FAT/SAT execution

  • Each session produces something your team can use the following week

  • Built specifically around your projects

How an engagement works

Every engagement starts with a benchmark. I map your current process against the SGP Quality Engine and identify the gaps. We then agree on what to address first. From there we work through the changes together, on a live project or in a dedicated sprint.

  • 1. Current state review

    A map of your process against the five phases of the model.

    Two men in a technical discussion inside an industrial or laboratory environment with machinery and pipes around them.

  • 2. Gap analysis

    A list of what is working and what is carrying risk.

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  • 3. Recommendation

    A prioritised set of changes with a realistic timeline.

    Two men engaged in a discussion at a table with a laptop displaying a technical drawing or 3D model. One man is smiling and gesturing with his hand, while the other man is listening attentively.

  • 4. Implementation

    I work through the changes with your team and stay until the process is running.

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  • Building long-term capability

    For engineering managers who want ISPE GAMP 5 capability built into their business, I offer a strategic engagement. The outcome is a project model your team owns, and a Supplier Quality Plan your sales team can present to customers.

  • How to get started

    Most engagements start with a conversation about where your project stands. I’ll ask about your current process and tell you what an engagement looks like.

Talk to me about your project
Ask me a question