Pharma
A failure on qualified equipment is also a deviation.
In a GMP plant the questions arrive after the fact: what happened, what was observed, the root cause, what was done, who verified it and whether it had happened before. Norlan captures those answers at the machine, in the thread and at closure, so the investigation starts from a record rather than from a blank page — and quality decides with it in hand.
Deviation · tablet press TP-30 · unit 1
Maintenance evidence for the investigation
What happened, and when
The thread · opened 02:14 by M. Solans
What was observed
Photo of the tablet press die table · 02:19
Root cause
Closure · dosing cam wear, not the feeder
What was done
Closure · cam replaced like-for-like, P/N on record
Who verified it, and when
T. Walker · on the machine · 03:05
Has it happened before
Model TP-30 · twice, on unit 2 · both closed
Impact on the batch
Quality decides. Not in Norlan.
Written when it happened, by the people who did it.Export
The effectiveness check
Whether the CAPA held is read from the machines, not asserted in a form
A corrective action is closed when it is signed; it is effective when the failure stops coming back. Norlan reads that from the record of every unit of the model: how many times the failure has returned since the fix, on which units, and whether a later closure names a different cause. When one unit comes back with a different root cause, the review sees it before it signs the CAPA off as effective.
- Occurrences since the fix, per unit of the model, from the closures
- A later closure that names another cause is shown as such, not folded into the CAPA
- The fix that held is the one the assistant cites; the one that did not stays visible
Effectiveness check · dosing cam wear
Tablet press TP-30 · fix closed 14 Apr · 92 days
Occurrences since the fix, by unit
Unit 1 · Lyon
none
Unit 2 · Lyon
none
Unit 3 · Basel
none
Unit 4 · Basel
1 · 3 Jul · closure superseded
Unit 4 came back once. Its closure names a different cause — feeder alignment — so the CAPA is not what failed. Worth a look before the effectiveness review signs it off.
Parts and changes
What changed on a qualified machine, on the record the day it changed
A like-for-like replacement is routine; a new part number on qualified equipment is a change-control question. Closing in Norlan records the part, the number and the person as part of the closure, so the difference is visible the day it happened — not discovered at the next audit. Norlan does not decide whether the change needs requalification; it makes sure quality decides with the record, and that the record was not written afterwards.
- Part and part number recorded at closure, by the technician who fitted it
- Like-for-like or not, visible per intervention, per unit
- Exported to the change-control file; the decision stays with quality
Tablet press TP-30 · unit 4
Parts replaced at closure · this year
| When | Part | Like-for-like | By | File |
|---|---|---|---|---|
| 14 Apr | Dosing cam · P/N 4471-C | yes | T. Walker | exported |
| 02 Jun | Punch set · station 7 | yes | N. Bermúdez | exported |
| 03 Jul | Feeder drive · P/N 5120-B → 5120-D | no · new P/N | M. Solans | pending |
Norlan records the change. Whether it needs requalification is quality's call, made with the record in hand.
Attribution
Who saw it, who worked it, who was let in from outside
An auditor asks who had access to the record and who wrote what. In Norlan every message is attributed and timestamped, quality can be given read access to the thread of a qualified machine, and the manufacturer's service engineer is admitted to one thread — that one — and revoked at closure. There are no private messages: what was said about the machine is on the machine.
- Groups and roles per asset: read, take part, or everything
- The manufacturer's engineer sees the thread they were admitted to, and nothing else
- Every message with its author and time; no side channel
Who was in the thread
Tablet press TP-30 · unit 1 · 14 Apr
Take partMaintenance · Lyon
opened, worked and closed the thread
ReadQuality · Lyon
read the closure · 08:10
This thread onlyManufacturer · service engineer
admitted 02:31 · answered 02:44 · revoked at closure
Every message attributed and timestamped. No private messages: what was said is on the record.
Where the line is today
Norlan is not a validated system.
It does not generate GMP records, it does not carry electronic signatures under Part 11, and it does not track calibration or qualification status. The QMS and the CMMS keep doing that. Norlan is the maintenance memory next to them: what was done on the machine, by whom, when, and whether it worked, exportable when quality asks. What validating Norlan itself would take in a GxP plant is a conversation for the call, not a claim on a page.
Questions from pharma plants
Is Norlan a GMP or 21 CFR Part 11 system?
Can quality use a closure in a deviation investigation?
Does Norlan track calibration and qualification status?
What happens with a part that is not like-for-like?
How is our operational data handled?
Book a demo
Bring the last deviation that started from a blank page. We will show what the machine would already have said.
We start with the operation — which failures repeat, who gets called when something breaks, what the CMMS does not hold — and then show how Norlan would work on it.
What we usually cover
- How an incident flows today, from detection to fix
- Where the conversation actually happens: the systems, or calls and WhatsApp
- What takes longer — the diagnosis, or getting the right people and information together
- How much of what a technician knows is written down, and what happens when they are away
- Which tools are really in play: CMMS, ERP, mobile, paper
- What a pilot would measure, and how
Pick a time that suits the plant. Bring one failure that keeps coming back.
The call is with the people who build the product, with no qualification call first. Norlan is pre-general-availability and shaped with maintenance teams in pharma and food processing.