Validierungskosten und Überstunden durch ineffiziente IQ/OQ/PQ-Prozesse

Definition

Annex 15 explicitly requires that qualification and validation activities are performed by suitably trained personnel using approved procedures, and that there is appropriate quality oversight over the whole validation lifecycle.[4] Industry best-practice articles recommend smart, modular templates, risk-based approaches and digital document tracking to avoid duplicated testing and excess paperwork.[5][1][3] Where these practices are not adopted, every new equipment qualification or requalification involves recreating or heavily editing protocols, manual data entry, physical signatures and repeated QA review cycles. In high‑cost Australian labour markets, this translates into substantial overtime for validation, QA and engineering plus frequent use of external validation consultants. Typical mid‑size sites employ several FTEs focused partly or fully on validation; even a 20–30% efficiency gap versus digitised, template‑driven practice can equate to 1–2 FTEs worth of time plus 5‑ or 6‑figure annual consulting invoices.

Why This Matters

The Pitch: Australian 🇦🇺 pharma manufacturers often spend an extra AUD 150k–500k per site per year in validation labour, overtime and consultants because IQ/OQ/PQ is template-heavy and manual. Standardised, risk-based and digitalised qualification can cut these costs by 20–40%.

Affected Stakeholders

Validation Manager, Head of Quality / QA Manager, Engineering Manager, CFO / Finance Business Partner, Project Manager for new equipment

Related Business Risks