CQV Advisory Support

Commissioning, Qualification & Validation guidance for equipment, utilities, and process systems.

Process Validation Advisory*

PPQ strategy, sampling plans, acceptance criteria, and lifecycle alignment.

Process Parameter/setting Mapping & KRPN Prioritisation

Structured mapping of critical parameters/setting and risk drivers.

Includes: parameter/setting mapping, criticality classification, KRPN scoring, early‑warning indicators, control‑limit guidance, advisory report.

Validation & Lifecycle Compliance Support*

Strengthening validation documentation, CPV capability, and regulatory alignment.

Includes: documentation review, CPV analysis, regulatory gap assessment, lifecycle monitoring recommendations, audit preparation support.

Process Drift & Troubleshooting Analysis

Identification of drift patterns, root‑cause drivers, and stabilisation strategies.

Includes: historical data review, drift pattern identification, root‑cause investigation, corrective/preventative recommendations, stabilisation advisory plan.

PTMS / KRPN Platform (MVP Pilot)

PTMS — Parameter Traceability Management System™

Traceability of equipment settings, change tracking, mapping workflows, lifecycle monitoring.

KRPN — Centralised Risk Priority Number™

Structured risk scoring, predictive capability, early‑warning indicators, stronger decision support.

Pilot Access for SMEs

Digital parameter mapping, automated KRPN scoring, early‑warning dashboards, monthly advisory review reports.

*Client retains full responsibility for validation execution and compliance.