Sector · Healthcare and biotech

Reporting for healthcare and biotech

Your data serves two audiences: your teams, who steer, and your auditors, who verify. A model that holds both is built from the start with traceability as a requirement, rather than added afterwards.

Expert consultants: 11
Projects delivered since 2019: 100+
Of scoping workshop, free: 2 h
Saint-Priest, and the whole region: Lyon

Where the figures come from

The systems we connect in this sector

The ERP and production

Batches, serial numbers, production orders, expiry dates and any recalls.

Quality and compliance

Release testing, non-conformities, corrective actions and batch records, often kept in a dedicated tool.

Distribution

Shipments, cold chain, wholesalers and field returns, with the device or batch identifier kept end to end.

Research and trials

Project tracking, budget consumption, regulatory deadlines and study milestones.

What you follow

The indicators these companies really watch

These are the ones we find from one project to the next. Your list will differ at the edges, and refining it is the work of the scoping workshop.

Traceability both ways

From a delivered batch back to its components, and from a component forward to everything it went into. That double reading is prepared in the model, and it becomes immediate the day it is needed.

Right-first-time release

Batches released without rework, by line and by product. This indicator summarises process control better than an overall conformity rate.

Release lead time

Time between the end of production and availability, broken down into waiting for testing, testing, and documentary review.

Non-conformities and their follow-up

Open, in progress, closed, with their age and their cause. The curve of actions whose deadline is approaching is the one auditors look at first.

Cover and expiry

Available stock set against requirements, with the nearest expiry date. A comfortable cover that expires in two months calls for a decision.

Progress of projects and studies

Milestones met, budgets consumed and regulatory deadlines ahead, on one view shared by the project teams and the board.

What calls for care

The points where these projects are decided

They come back almost every time in this sector. Knowing them in advance changes how the project is run, and the order in which things are done.

Frequently asked

What people ask us about this

Does your work fall within a validated scope?

We work regularly with companies subject to traceability and documentation requirements, and we document our transformations accordingly. Qualifying a system belongs to your own quality processes: we provide the material and the traceability they need, and we move forward with your quality teams on that point.

Can a delivered batch be found in seconds?

Yes, once the chain is modelled from raw material to shipment. It is one of the cases where the semantic model shows best: the search becomes immediate where it previously meant several extracts brought together by hand.

Our trial data lives in spreadsheets, is that usable?

Yes, and it is common. We take them in as they are, keeping the original file as the reference. A stable place to drop them makes the flow reliable, and that is often the only thing we ask you to fix.

Other sectors

We also work here

Let us talk about your case.

Eleven expert consultantsSaint-Priest, near Lyon, France

Two hours with a consultant to look at your sources, measure the volumes and spot the rules to settle. Free and without commitment.

Request a scoping workshop

No commitment · in Saint-Priest, at your offices or over video