Equipment Qualification Tracker
Pharma equipment qualification records live in folders and binders — and nobody knows when the next requalification is due.
CAPABILITIES // WHAT GETS BUILT
What this system delivers for your team
Equipment registry with IQ/OQ/PQ qualification status per item
Protocol upload and version control per qualification event
Requalification scheduling with automated alerts 60/30 days in advance
CAPA linkage — direct connection from deviation to corrective action
21 CFR Part 11-aligned electronic audit trail with user, timestamp, and reason for change
QA approval workflow for qualification reports before marking complete
Dashboard view for regulatory inspections — status, history, and upcoming schedule at a glance
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 Manager / Validation Head
Pharmaceutical manufacturer, API producer, or regulated medical device company with GMP compliance obligations
Qualification documents are in paper binders — finding a specific record during an FDA or CDSCO inspection takes hours
- —Qualification documents are in paper binders — finding a specific record during an FDA or CDSCO inspection takes hours
- —Requalification dates are tracked in an Excel sheet that someone updates irregularly
- —There is no audit trail when qualification records are corrected or updated
BEFORE
IQ/OQ/PQ records are stored in paper binders organised by equipment. Requalification due dates are tracked in an Excel sheet updated irregularly. When an FDA or CDSCO inspector asks for a specific qualification history, locating and presenting it takes hours.
WITH THIS SYSTEM
Every equipment item has a digital qualification record with IQ/OQ/PQ status, protocol version history, and a requalification schedule. Automated alerts fire 60 and 30 days before any requalification is due. During inspections, the complete qualification history for any equipment is accessible in under 30 seconds.
KEY OUTCOME
Equipment with requalification overdue discovered during inspections: recurring → 0
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 Equipment Qualification Tracker?
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.