CAPA Action Tracker
Every CAPA assigned. Every root cause closed. Every deadline tracked.
PharmaManufacturing
DEPLOY:5–8 WKS
Pharma
Your qualification records are in binders. Your CAPAs have been open for 8 months. Inspectors are scheduled.
I build GMP-aligned quality management and compliance tracking systems for pharmaceutical manufacturers and API producers — replacing the paper binders, Excel trackers, and email chains that fail under regulatory scrutiny.
Where are you right now?
Starting out
Starting a pharmaceutical manufacturing or API facility?
Get GMP-compliant quality management systems in place before your first regulatory inspection — not scrambling to document after it. Start with the compliance infrastructure that serious manufacturers run on.
Build from scratchEstablished & scaling
Already certified but managing QMS on paper, email, and shared folders?
Replace fragmented quality workflows with a single auditable platform. CAPA, batch deviations, equipment qualification, and training records — all connected, all traceable, all inspection-ready.
Expand your operationsVOICES // FROM THE FIELD
If this is you…
We had 45 open CAPAs when the FDA inspector arrived. We couldn't show effectiveness verification for a single one.
Equipment requalification was 4 months overdue when the auditor asked for the certificate. We had no tracking system.
One deviation led to 3 CAPAs. All three are technically open. Nobody knows who the action owner is.
SYSTEMS // BUILT FOR PHARMA
Systems I build for pharma organisations
● Live demos · 1 system
Also available to build
○ Buildable · 2 systems
Equipment Qualification Tracker
Pharma equipment qualification records live in folders and binders — and nobody knows when the next requalification is due.
Pharma
DEPLOY:6–9 WKS
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.
PharmaManufacturing
DEPLOY:12–20 WKS
Relevant compliance frameworks
Schedule M (GMP)
Indian GMP requirements under Drugs and Cosmetics Act — equipment qualification, CAPA, and batch documentation
US FDA 21 CFR
21 CFR Part 211 (cGMP) and Part 11 (electronic records) compliance for US-export manufacturers
WHO-GMP
World Health Organisation Good Manufacturing Practice standards for pharmaceutical exporters
EU GMP (EudraLex)
Annex 11 (computerised systems) and Annex 15 (qualification and validation) compliance
ISO 15378
Primary pharmaceutical packaging material GMP requirements
CDSCO Compliance
Central Drugs Standard Control Organisation registration, licensing, and inspection compliance
My systems are built with these frameworks in mind. I can't provide legal advice, but I build the tools that make compliance trackable.
INVESTMENT // WHAT IT TYPICALLY COSTS
Pricing context for Pharma
TYPICAL SYSTEM FOR PHARMA
₹2L – ₹5L
one-time build · price estimated after scoping
- Equipment qualification tracker with IQ/OQ/PQ status
- CAPA register with root cause and effectiveness verification
- Regulatory deadline compliance calendar
- Electronic audit trail for 21 CFR Part 11 alignment
- Regulatory-ready export for FDA, EMA, and CDSCO inspections
Maintenance from ₹12,000/month after delivery
THE ROI CASE
One FDA Warning Letter costs $5–50M in revenue due to import alerts and remediation. One CDSCO suspension stops production. A quality system that prevents these outcomes is not a cost — it is insurance.
₹1 spent → regulatory confidence worth multiples more
Ready to be inspection-ready without the last-minute scramble?
GMP-aligned quality systems built for pharmaceutical manufacturers — qualification tracking, CAPA management, and electronic audit trails.
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