Clicarity Medical Devices
🏥 Industry · Medical Device Manufacturing

Made in a day. Released in two weeks. Where did the time go?

How long a device really waits on its record. Whether your CAPAs are closing inside their window. How fast you could scope a questioned sterilisation load.

One manufacturer measured fourteen days from device made to device released. Manufacturing was one of them.
Medical device manufacturers — full DHR traceability live
As featured in PrintWeek India, April 2026 ↗

Three manufacturers. Each one was fast at making and slow at proving it.

01 The DHR that took a week to close

A device history record must be complete before release. It is completed by several people across several days.

Product sits waiting not for testing but for a signature, a correction, a missing entry — and nobody is watching how long any of it has been waiting.

Device made to device released
Manufacturing1.2 days
Record completion4.5 days
Review and correction7.8 days
Release0.8 days

Every entry is captured at the step by the person performing it, so review begins complete.

14.3 days → 4.6 daysmade to released
Find out howFifteen minutes. Bring one batch.
02 Complaint to CAPA, and the clock

A complaint arrives. It must be investigated, a root cause found, a corrective action raised and closed, within a defined time.

The steps happen. The clock on each is watched by one person, and when several complaints run at once, one of them quietly exceeds its window.

Complaint handling, one quarter
Closed within target23 cases
Closed late19 cases
Still open past target9 cases

Each stage carries its own due date and surfaces before it is breached, not after.

19 late → 4same quarter next year
Show me howFifteen minutes. Bring one open case.
03 Sterilisation lots and what they contained

A sterilisation load contains product from several batches. If a load is questioned, you need everything in it and everywhere it went.

That connection lives across a load record and a dispatch book, so scoping the exposure takes a day you do not have.

Time to scope one questioned sterilisation load
From load records and books1.5 days
From spreadsheets5 hrs
Tracked at loadingMinutes

Batch attaches to load, load attaches to dispatch. Forward and backward trace is one query.

A day → minutesto scope any load
Show me howFifteen minutes. We trace one live.

Quality was never the delay. Quality recorded afterwards, on paper, was.

Every batch. Every stage. Every DHR entry tracked.

This is how a print job moves through your business. Clicarity gives you live visibility at every phase — and flags delays before they become client calls.

01
Component Receipt & Incoming QC
4 stages
Purchase Order & Component Receipt
All components received per approved BOM with certs and COAs.
✓ Clicarity: Lot number and supplier cert recorded — full traceability chain begins
Incoming QC
All components tested against approved specifications.
⚠ ⚠ Common delay: incoming failure — production hold while supplier resolves
Quarantine Release
Components released from quarantine after QC approval.
✓ Clicarity: Release logged with QC sign-off — components cannot enter production without
Component Issuance
Approved components issued to production per batch BOM.
✓ Clicarity: Issued quantities logged — batch BOM accountability begins
02
Assembly & Sub-Assembly
4 stages
Sub-Assembly
Sub-components assembled per approved work instructions.
✓ Clicarity: Operator ID and work instruction version logged per sub-assembly
Final Assembly
Device fully assembled per device master record.
✓ Clicarity: Assembly checklist confirmed — no step skipped without sign-off
In-Process Inspection
Critical assembly checkpoints verified per control plan.
⚠ ⚠ Common delay: non-conformance at in-process check — batch held for disposition
Functional Testing
Device tested for specified performance parameters.
✓ Clicarity: Test result logged per unit or batch — non-conforming units tracked
03
Sterilisation & Validation
3 stages
Pre-Sterilisation QC
Final visual and dimensional inspection before sterilisation.
✓ Clicarity: Pre-sterilisation acceptance confirmation — batch cannot proceed without
Sterilisation
Batch sterilised per validated process — EO, gamma, or autoclave.
✓ Clicarity: Sterilisation cycle parameters, date, and PCD result logged per batch
Sterilisation Release
Batch released after sterility assurance confirmed.
⚠ ⚠ Common delay: parametric release delayed — batch in quarantine, customer order waiting
04
Labelling, QA Release & Dispatch
3 stages
Labelling & Coding
Approved labels applied — device name, lot number, expiry, UDI.
⚠ ⚠ Common delay: label version not approved — batch held for correction
QA Final Release
Complete DHR reviewed and batch released by QA.
✓ Clicarity: DHR completeness automatically verified — dispatch blocked without sign-off
Dispatch
Batch dispatched with full documentation — COA, sterilisation cert, DHR reference.
✓ Clicarity: Full lot traceability from component receipt to dispatch preserved
""FDA audit readiness used to mean a week of manual record compilation before every audit. Now the DHR is built automatically as production progresses. Audit preparation time: 4 hours.""
QA
QA Manager
Medical Device Manufacturer — Bengaluru
As featured in PrintWeek India, April 2026 — Vol 18, Issue 12 ↗ Also in Print Bulletin, May 2026 — Pages 20–21 ↗

What improves in medical device businesses using Clicarity

↓ 85%
Audit preparation time
100%
DHR completeness at dispatch
↓ 50%
CAPA resolution time
5 days
To go live — full setup included

Questions from medical devices businesses

How does Clicarity work for a printing business specifically?
Clicarity is configured around your specific print workflow — pre-press, printing, finishing, dispatch — in your terminology. Every job gets a unique ID and moves through your defined stages. You see live status, timestamps, and alerts when a job sits too long at every stage. The Clicarity team builds everything for you. You go live in 5 days.
Does it work for both offset and digital printing?
Yes. Clicarity works for any print process — offset, digital, wide format, screen printing, or a combination. The stages are configured around your actual workflow. If offset jobs go through plate making and digital jobs skip that stage, both can be tracked correctly under the same system.
Can it track material wastage at each stage?
Yes — with the Multi Licence. At every stage, your team logs quantity in and quantity out. Clicarity calculates the loss automatically. You see wastage by stage, by job, live — not at month-end when nothing can be done about it.
Will my press operators actually use it?
Yes. The update screen has two fields — Job ID and status. Under a minute. No training needed. GP Offset's entire team was using it from day one, including floor workers who had never used a software system before.

Full DHR. Every batch. Audit-ready at any time.

Book a free demo. We'll map your medical device workflow live on the call.

No commitment Live in 5 days Annual licence Full setup included