Produktivitätsverlust durch manuelle Änderungsdokumentation

Definition

In pharma, the change control process formally covers the change request, assessment, approvals, implementation and closure, and must be documented for regulatory purposes to ensure quality and efficacy are not compromised.[3] Australian GMP guidance (PIC/S PE009‑16) requires that changes, deviations and associated testing are documented in batch records and product specification files, with signatures of persons performing and supervising each critical step.[1][4] Industry observers highlight that regulated industries face extensive documentation requirements for each change, including detailed proposals, risk assessments and approvals.[8] In practice, when this is handled via paper forms, spreadsheets and email, QA and production staff spend substantial time drafting, circulating, correcting and filing documents and chasing approvals. Logical benchmarking from GMP sites indicates around 1–3 hours of QA and production time per minor change and 8–16 hours per major change for documentation alone. For a mid‑size Australian manufacturer processing 200–400 changes per year, this equates to roughly 400–1,200 hours annually. At a blended fully loaded labour cost of AUD 80–120/hour, this is a capacity loss of roughly AUD 32,000–144,000 per year.

Why This Matters

The Pitch: Pharmaceutical manufacturers in Australia 🇦🇺 waste 400–1,200 QA and production hours per year on manual change control documentation and approvals. Automation of change request capture, workflow routing and record generation frees these hours for value‑adding manufacturing and improvement work.

Affected Stakeholders

Quality Assurance officers, Quality Systems / Documentation staff, Production Supervisors, Engineering / Maintenance leads, Regulatory Affairs specialists

Related Business Risks