Paper-based calibration logs, delayed CAPA closures, and fragmented SOP documentation across production, quality, and engineering departments.
$1.6M annual savings from reduced batch revalidations, faster approvals, and zero non-compliance penalties.
Audit trails scattered across files; QA teams spent days compiling evidence for inspections.
All SOPs, CAPAs, and calibration histories digitized and traceable within minutes. CAPA closure time reduced 70%.
In the pharmaceutical industry, compliance is not optional—it's existential. For this leading API and formulations manufacturer, every production stage required precise documentation: who did what, when, and under which SOP. Yet most of it lived in binders and spreadsheets. During an audit, a missing calibration record could trigger days of scrutiny or, worse, halt production. CAPA reports were handwritten, and follow-ups depended on email reminders. While the company had robust teams and systems, their processes were digital in islands but manual in flow—a compliance paradox. When regulators tightened documentation timelines, the leadership realized that the cost of inefficiency wasn't just regulatory—it was cultural. A reactive, paper-driven quality process was stifling innovation.
The company's QA, maintenance, and production teams operated across three large facilities. Each maintained its own calibration sheets, deviation logs, and CAPA templates. Quality inspectors often had to physically visit maintenance rooms to confirm instrument calibration. Audits became an exhausting ritual of searching through folders, printing PDFs, and matching signatures. In one instance, a delayed CAPA response triggered an entire batch revalidation—costing the company several million rupees in material, manpower, and lost production hours. It wasn't a lack of compliance intent; it was a systematic gap in process visibility.
Are your audits reactive instead of real-time?
