Functional analysis & GMP
Everything around the code that carries equal weight in a regulated environment: defining what the system must do, and proving that it does.
When do you need it?
- A project in a GMP environment has to be validated.
- There is no functional analysis, or it is out of date.
- You need support with FAT, SAT or qualification.
- Documentation has to be in order for an audit.
Which systems?
- GMP / GAMP 5
- Functionele en ontwerpspecificaties
- FAT / SAT / kwalificatie
What do you get?
- Functional analysis (FS) and design specifications
- Test protocols and executed test reports
- Traceability from requirements to tests
- A documentation package ready for QA review
Drag to rotate · Ctrl + scroll or +/− to zoom · Click an item for an explanation
Tap to enlarge The V-model around a WFI skid: specifications descend on the left, the skid is the build at the bottom and tests climb the right, each linked to the specification it verifies.
Got a project in mind?
A short description, photo or drawing of your installation is enough to get started.