Pharmaceutical Quality Management System
QA runs on paper — CAPA registers in Excel, SOPs in shared folders, calibration records in a binder — and inspectors cite the same observation about documentation control at every audit.
CAPABILITIES // WHAT GETS BUILT
What this system delivers for your team
CAPA module with root cause analysis templates, effectiveness check scheduling, and regulatory-ready closure report with full time-stamped audit trail
Deviation logging with severity classification, impact assessment, and approval workflow before batch release
Equipment qualification tracker (IQ/OQ/PQ) with calibration schedule, certificate repository, and out-of-calibration alert 7 days before due date
SOP lifecycle management — draft, review, approve, effective date, periodic review cycle, and superseded version archive
Audit management with finding log, CAPA linkage, and audit response preparation workflow
Training records with competency assessment, retraining schedule, and compliance matrix showing who has read which SOP version
Every build is scoped to your organisation's workflow — features and modules may vary.
PROCESS // HOW I WORK
From scoping call to live system
Scoping Call
A 30–60 min free call to understand your workflow, team structure, and exact requirements. No commitment — just alignment.
Custom Build
I build the system to your specifications with weekly updates. All work is tracked — you see progress before final delivery.
Delivery & Handoff
Deployed to your infrastructure, your team trained, documentation handed over. Optional AMC for ongoing support.
FIT // WHO THIS IS FOR
Who this system is for
QA Director / Plant Head / Regulatory Affairs Head
Pharmaceutical manufacturer, API producer, or formulation unit with WHO-GMP, Schedule M, or ISO 9001 certification where the quality management system is paper-based or spread across Excel, shared folders, and physical binders — and the organisation has received observations about documentation control or CAPA effectiveness in the last regulatory audit
An FDA or WHO inspector asks to see the CAPA for a deviation raised 8 months ago — the QA manager searches through 3 folders and 2 Excel files for 20 minutes before finding it, and the inspector notes the lack of a traceable, time-stamped system
- —An FDA or WHO inspector asks to see the CAPA for a deviation raised 8 months ago — the QA manager searches through 3 folders and 2 Excel files for 20 minutes before finding it, and the inspector notes the lack of a traceable, time-stamped system
- —SOPs are in a shared Google Drive folder — nobody knows which version is current, multiple versions are in circulation on the production floor, and there is no record of who has read and acknowledged the current SOP
- —Equipment calibration is tracked in a physical register — a piece of equipment ran out of calibration for 45 days before anyone noticed, and the affected batches now need retrospective investigation
BEFORE
CAPAs are in an Excel maintained by the QA executive. SOPs are in Google Drive with no version control. Calibration records are in a binder on the QA manager's desk. Training records are in a register signed by employees. Audits result in a Word document observation list tracked in another Excel. Every regulatory inspection surfaces the same documentation observations.
WITH THIS SYSTEM
Every CAPA has a root cause, an action owner, a deadline, and an effectiveness check date — all in the system with a complete time-stamped audit trail. The effective SOP is the only version visible to production — superseded versions are archived automatically. Calibration alerts trigger 7 days before due date. Training compliance is a live percentage per department. Inspectors see a system, not a filing cabinet.
KEY OUTCOME
Open CAPA rate at regulatory inspection: ~60% → under 5%. Documentation-related inspection observations: the leading category → eliminated as a repeat finding. Calibration overdue incidents: 3–4 per year → near zero.
BUILD // WHAT I DELIVER
What gets built for you
PROCESS // HOW IT WORKS
Every build starts with a scoping call. I understand your workflow, adapt the system to your team, and deliver a detailed price estimate before any work begins.
Ready to scope Pharmaceutical Quality Management System?
Book a free scoping call. I'll map your workflow, align the build to your team, and provide a detailed price estimate based on your requirements.
WORKS WELL WITH
These systems are commonly scoped together or phased into a connected build. Let me know during the scoping call if you're considering a multi-system setup — I'll structure the engagement accordingly.