Pharma — GxP Supplier Qualification Looking for the platform demo? →
Illustrative demo mockup

This page is a representative product demo designed to show the DIIaC™ Pharma governed decision workflow. It is not the live production UI, not a live customer decision, and not generated from an active tenant dataset. The animated screens, sample scores, report layout, supplier names, and sector examples are illustrative only. In the deployed DIIaC™ Pharma build, governed outputs are generated through the live platform, tenant configuration, evidence inputs, human-review workflow, signing, verification, and export controls.

Pharma demo The GxP supplier qualification scenario is a fictional example used to illustrate regulated-sector governance patterns. It is not regulatory advice, validation evidence, certification, or a live supplier qualification decision.
FREEZE
COLLECT
NORMALISE
BIND
GENERATE
ENFORCE
RENDER
INTENT CAPTURE — Stage 1 of 7
0:00 / 1:05
GOVERNANCE OUTPUT
Board-Level Decision Report
Signed artefact — independently verifiable — human review required
DIIaC®
PHARMA BUILD SIGNED ✓
DECISION PACK ID: PHG-2026-03157
COMPILED: 19 May 2026 · 14:38 UTC
EVIDENCE MODEL: Pharma Supplier Qualification
GOVERNANCE BUILD: v1.8.0
GxP CTMS Vendor Qualification
Pharma Supplier Qualification — GxP Evidence Model · 10 Regulatory Frameworks Enforced
Executive Summary
This governed decision pack presents the qualified recommendation for GxP CTMS vendor selection, compiled through the DIIaC™ Pharma Supplier Qualification evidence model. Three validated system vendors were assessed across pharma-specific governance dimensions. Pharma hard gates were enforced throughout. All 10 regulatory frameworks (EU GMP Annex 11/15, ALCOA+, ICH GCP, EU AI Act, EMA GVP, GDPR) have been applied at the compile path. Evidence has been bound at compilation — not attached post-hoc. This artefact has been cryptographically signed and is independently verifiable. Human review and explicit accountability state are required before this qualification recommendation is acted upon.
Governed Recommendation
RECOMMENDED SYSTEM
System Alpha — GxP-Validated CTMS
Highest composite score across ALCOA+ Data Integrity (93), CSV/CSA Readiness (91), and Operational Readiness (89). Vendor dossier complete. Annex 11/15 controls satisfied. ICH GCP evidence bound. Human scientific review of evidence binding required before qualification decision.
91
COMPOSITE
SCORE /100
ALCOA+
93
CSV/CSA
91
OPS READY
89
GCP CTRL
88
COMMERCIAL
84
Evidence Binding Summary
Evidence ClassSourceStatusBinding
Vendor GxP Dossiers3 CTMS vendors · Regulatory history + validation evidence✓ CompleteBOUND AT COMPILE
CSV/CSA ReadinessAnnex 11/15 validation documentation reviewed✓ CompleteBOUND AT COMPILE
ALCOA+ Data IntegrityMHRA GxP Data Integrity Guidance controls✓ EnforcedPOLICY ENFORCED
ICH E6(R3) GCP ControlsGood clinical practice policy pack applied✓ EnforcedPOLICY ENFORCED
EU AI Act Deployer ControlsRegulatory policy pack v1.0 — 10 controls✓ EnforcedPOLICY ENFORCED
Human Accountability StatePending explicit reviewer sign-off⏳ RequiredHUMAN REVIEW REQ.
Policy Compliance Matrix — 10 Regulatory Frameworks
EU GMP Annex 11 — Computerised Systems
EU GMP Annex 15 — Qualification & Validation
ALCOA+ — Data Integrity
ICH E6(R3) — Good Clinical Practice
EU AI Act Art. 14 — Human Oversight
EMA GVP — Applicable Controls
GDPR — Data Protection
Ed25519 Cryptographic Integrity
Human Review — Explicit Sign-Off
Qualification Ratification — Human Authority