Gunvatta QMS: replacing a pharma plant's paper quality system before the next inspection

When we first visited Gunvatta's QA department, one wall was lined with binders — deviations, CAPAs, change controls, training records — each labelled by year and department. The head of quality could find almost anything, but it took time, and linking a deviation to its investigation, its CAPA and the training that followed meant opening four binders and trusting that nobody had misfiled a page.

The trigger for the project was an upcoming inspection by an overseas regulator. Previous inspections had raised observations about record retrieval and the traceability of changes. The quality head wanted a system that could answer any inspector's question in minutes, with a complete and tamper-proof history behind it.

Pharma software is different: it must be validated to show it does exactly what it claims, and every requirement must be traceable to a test. So instead of loose user stories, we wrote a user requirements specification with the QA team, clause by clause, and a traceability matrix that followed every requirement through design, build and testing.

The quality team walked us through their SOPs for each process. We discovered that the paper forms encoded years of lessons — fields added after previous audit observations — and we preserved every one of them in the electronic forms.

The biggest improvement over paper was linkage. In Gunvatta QMS, a deviation opens an investigation, the investigation proposes CAPAs, each CAPA can trigger a change control and training assignments, and the effectiveness check closes the loop. Every record shows its parents and children, so an inspector's question can be followed end to end on one screen.

Shop-floor staff got a simplified tablet interface to raise deviations at the point they happen, with photos, instead of reporting them later from memory.

Validation work is substantial, so the team included a dedicated validation and QA lead from the first week.

Every decision here was documented in the design specification and reviewed by the head of quality.

Everything in the validated first release, organised by quality process.

We executed installation, operational and performance qualification protocols with the QA team, recording every test result and every deviation from expected behaviour. Open paper records were migrated with verification: each migrated record was checked against its paper original and signed off.

The system went live several weeks before the inspection, giving the team time to use it for real. During the inspection, QA staff retrieved linked records on screen as questions were asked.

In regulated software, documentation is a deliverable, not overhead. The traceability matrix made validation smoother and gave the QA team confidence in the system.

Respect the paper. The existing forms held years of institutional learning; migrating that knowledge faithfully mattered as much as the software.