GAMP-driven system validation — from supplier assessment to configuration binding.

40–60%

reduction in documentation effort

15–25%

faster validation cycle time

50%

less audit preparation time

Authoring aid, not an author. The quality team remains accountable for every claim the dossier makes.

GAMP Category Classification

SAGA-DEMO-0417 · Rev 01 · Approved 2026-04-03

SYS-LIMS-021 LIMS — Category 4 configured product verified
SYS-QMS-008 QMS — Category 3 non-configured product verified
SYS-SAP-VAL SAP QM module — Category 5 custom code pending
SYS-SCN-033 Barcode scanner firmware — Category 3 verified
SYS-EXCEL-004 Tracking spreadsheet — Category 1 tooling waived
URS → Supplier Assessment → FS → Test Case → Evidence

GAMP categories and supplier assessments

Computerised-systems validation under GAMP 5 asks a different question at every category. A Category 3 non-configured product wants evidence that installation and operation match the supplier's specification; a Category 4 configured product adds the rigour of URS-to-configuration binding; a Category 5 custom product pulls the full lifecycle all the way back to code review and test case design.

SAGA carries the GAMP category on every system artefact and lets the dossier shape scale with it. Supplier-assessment results bind to the system they qualify, so a Category 4 decision traces cleanly from the assessment through the functional spec to the test evidence. The dossier an auditor reads is the dossier your team has been authoring all along.

No tool retires your supplier-assessment judgement or your URS discipline. SAGA keeps both in the shape an EU GMP Annex 11 or FDA 21 CFR Part 11 inspector expects to see — and your signatures stay on every decision.

How the four GAMP categories shape the rigour

The category decision is the first load-bearing choice on a system validation project. Below-right rigour risks an inspector finding; above-right rigour risks burning a quarter on tests nobody needs.

  1. Category 1 — Infrastructure software. Operating systems, databases, and office tooling. Qualified as part of the environment rather than as products in their own right; evidence sits in the IT-qualification trail, not the system dossier.
  2. Category 3 — Non-configured products. Commercial off-the-shelf software used without configuration. The dossier focuses on vendor assessment, installation qualification, and a narrow operation-qualification scope covering the features your process actually exercises.
  3. Category 4 — Configured products. LIMS, QMS, ERP modules, and similar systems where business logic lives in configuration. URS binds to configuration items one-to-one; FS and test cases exercise every configured decision point. The supplier assessment carries more weight here — a vendor whose configuration layer is unsound throws the whole binding into question.
  4. Category 5 — Custom applications. Bespoke code written for your process. The full lifecycle applies: URS, FS, DS, code review, unit and integration test, installation, operation, and performance qualification. SAGA carries every layer of the V-model in one traceable chain; the custom-code review record is a first-class artefact, not a side file.

Our regulatory posture

Adoption looks the same, whatever the system state

Whether you are validating a new system at kickoff, retrofitting an in-production system whose dossier has drifted, or joining a validation project already in flight, the dossier shape stays consistent and the work already done keeps counting.

Greenfield

New validation projects start in SAGA from kickoff — the dossier shape is set the first day, and every artefact lands in the framework as it's authored.

Retrofit

In-production equipment and existing systems can be retrofitted into the framework so ongoing validation work joins SAGA without pausing operations.

In-flight

Mid-engagement validation projects load existing material into SAGA and continue in parallel — switching over fully when the dossier shape is ready.

See SAGA against your hardest system

Bring the GAMP category decision you are least sure of — a supplier assessment you want a second read on, a Category 5 custom application with a thin test record, a configured product whose URS has drifted from its configuration layer. A focused session, your artefacts in front of us, clear outputs.

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