When scope, design, and documentation drift, projects derail
The SGP Quality Engine applies ISPE GAMP 5 in real project execution.
“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
Does this sound familiar?
Documentation doesn’t
create value
Specifications are written after the design is finished
Templates are rewritten for every customer
Nothing carries over from one project to the next
The team has no flexibility
A few specialists hold all the critical knowledge
When they’re stretched, others can’t step in
Work can’t be shared across the team
Projects explode
Test plans, specifications, and the machine don’t match
Engineers, customers, and management lose confidence at the same time
It happens when there’s no capacity left to recover
The SGP Quality Engine integrates ISPE GAMP 5
in your project
The SGP Quality Engine addresses all three concerns by making ISPE GAMP 5 compliance part of how the machine is specified and designed, not a separate track that runs alongside it. The design direction is locked early, so the documentation and the machine stay consistent.
What changes when the model is in place
Documentation your customer can use
Requirements are traced from URS through design to test. Your customer gets a detailed package ready for regulatory qualification.
Scope defined before design starts
Deliverables and design direction are locked early. The customer knows what they’re getting. Your team knows what they’re building.
A process your team owns and repeats
The same structure on every project, regardless of which customer you’re building for. Your team improves with each project rather than starting from the same point each time.
Design and implementation by the same person
Behind the SGP Quality Engine is Rasmus Rud, a master builder who has spent 20 years working hands-on with custom pharma equipment. He developed the model after seeing the same problems repeat across ISPE GAMP 5 projects, where documentation, validation, and execution fall out of sync.
The model brings his master builder experience with lean project execution, based on ISPE GAMP 5.
“He understands how to build intended use and fail-safe design into processes, enhancing quality and collaboration internally and with customers.”
- Goran Rudan | Head of Project Management, VARO Specialmaskiner A/S