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  • There is no functional analysis, or it is out of date.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
GMP path from functional analysis to turnover dossier

Got a project in mind?

A short description, photo or drawing of your installation is enough to get started.

Book a feasibility call +32 479 77 81 04

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