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The SGP Quality Engine in practice

VARO Specialmaskiner had been building automation equipment for ISPE GAMP 5 projects for years. They wanted to refine their design process and project execution with a structured approach, and strengthen how they work across mechanical, hardware, and software disciplines.

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A man with glasses, short brown hair, and a slight smile, wearing a light green striped shirt, against a plain beige background.

“Ramus helped VARO improve project execution using the GAMP5 approach. He has deep GAMP5 knowledge and applies it through practical methods and templates. Ramus guided us in creating user-friendly templates throughout the project. He understands how to build intended use and fail-safe design into processes, enhancing quality and collaboration internally and with customers. With broad experience and attention to detail, I recommend Ramus for organisations seeking effective change management and GAMP5 implementation.”

– Goran Rudan | Head of Project management & Seniorpartner at VARO Specialmaskiner A/S

  • Open cardboard box with white paper padding inside, placed on a gray tiled floor.
  • A man in a gray shirt stands at a table holding a large technical project poster. The poster presents detailed information in sections with diagrams and text, color-coded in blue, red, and black. The table is covered with white tissue paper or fabric, and the background features a tiled wall and a partially visible white door.
  • Four men standing in front of a green wall, holding a detailed project model poster. The first man on the left is smiling, wearing glasses, a checkered shirt, and beige pants. The second man is smiling, bald, with a beard, wearing a black sweater and grey pants. The third man is bald, wearing glasses and a black shirt, holding the left side of the poster. The fourth man is standing with a slight smile, wearing a blue shirt and dark jeans, holding the right side of the poster.

Reducing project risk and correction loops

I delivered GAMP 5 in a Box: a complete ISPE GAMP 5 methodology covering intended use definition, fail-safe design integration, practical tools and templates, and a restructured Supplier Quality Plan. The work covered the project managers, designers, hardware engineers, software engineers, and the quality department.

The result is a stronger project model, new templates, and a consolidated SQP that represents internal process savings. For the VARO team, that means:

Clear direction

Intended use translated into a clear design direction from the start

Fewer corrections

Fewer correction loops through better early control

Closer collaboration

Closer collaboration across mechanical, hardware, and software

Better decisions

More detailed specifications and a clearer basis for decisions

For their pharma customers, it means more efficient projects, fewer unforeseen changes, and a higher level of quality and transparency throughout the process.

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  • Man in blue shirt giving a presentation using a large digital display in a conference room with two seated women taking notes.
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