For biotech and pharma
Audit evidence a pharma auditor will accept.
A global pharmaceutical manufacturer counts a whole warehouse, dry, ambient and frozen, in under four hours with one employee, and the reports come out of the same reconciliation the floor works from. All data and all processing run on the site's own premises.
Why pharma stock is a different kind of problem
The pallet is not the asset. The batch is.
Pharmaceutical inventory carries two pressures a normal distribution pallet does not: a regulator expects a verifiable count with an audit trail, and the stock itself is high value and often temperature sensitive, so the cost of a discrepancy is never just the pallet. It is the batch, the compliance exposure and the time spent proving what happened afterwards.
Batch and lot codes are read at the same resolution the system uses to identify the pallet itself, which is why the mapping to your own label layout is validated on day two of deployment rather than assumed. Bring an example label to the demo and we will show you the read against your own format instead of describing it.
The temperature regimes are part of the same problem. Stock sits dry, ambient and frozen down to minus 23 degrees in one building, with staff moving between the zones repeatedly during a shift, and one count method covers all three without changing how the count is done. The mechanics of counting a frozen zone are on cold chain and frozen storage, including what the recording unit tolerates and where it has to be parked between runs.
Audit evidence, GxP adjacent
A count your quality team can defend, not just trust.
What the count produces sits alongside the wider GxP adjacent controls your quality function already runs. It does not replace them, and it does not claim a qualification it has not been through.
The limits of the claim. Sentispec Inventory produces audit evidence from the stocktaking process itself. There is no claim of formal GxP validation, 21 CFR Part 11 certification, or any regulatory qualification of the recording unit or the software. Cyber security is implemented to the ISO 27001 standard and externally audited according to ISAE 3000.
Where the data lives
All data and all processing stay on your own premises.
Sentispec is a Danish company. The recording unit and the recognition processing both run at your site, with no third party sharing, so the data residency answer is the standard configuration rather than a special one.
Retention is your decision, because the data sits on the unit at your own site. Sentispec can reach it only temporarily, for support or maintenance. What the camera captures, who can open a recording and how a data processing agreement is handled are set out on security and data, and the wider finance and audit case is on finance, audit and risk.
Measured in regulated cold storage
Pharma and food, both temperature governed, both live.
| Location | Pallet locations | Accuracy after go live | Sector | Value realised | Break even |
|---|---|---|---|---|---|
| Geel, Belgium | 7,000 | 99.99%+ | Pharma | 85% lower stocktaking cost, alignment with safety regulation | 6+ months |
| Kolding, Denmark | 25,000 | 99%+ | Food | 80% lower stocktaking cost, 80% fewer loading errors | 6 months |
For the mechanics of counting a frozen or chilled zone specifically, see stocktaking for cold chain and frozen storage. All ten published deployments, with the method behind the numbers, are on the benchmark page.
Questions we get asked
Before this goes to quality or compliance.
Where exactly is our data stored?
On your own premises. All data and all processing run at your site, with no third party sharing. Retention, access and what the camera captures are set out on the security and data page.
Can we hand a discrepancy report straight to an auditor?
Yes. Auditor approved reports are generated automatically from the same reconciliation the floor works from, and every discrepancy line opens the recording that produced it.
Does it capture batch or lot numbers as well as the pallet?
Yes. Batch and lot codes can both be captured, and so can the pallet identifier. All three are read from the label as the unit passes the position. The mapping to your own label layout is validated on day two of the five day deployment, so bring a sample label to the demo and we will read it against your format rather than describe it.
Is this validated for GxP environments?
The audit evidence it produces, a reconciliation against your WMS with a recording behind every discrepancy, supports a GxP adjacent quality process. It is not a formal GxP or Part 11 certification. Cyber security is implemented to the ISO 27001 standard and externally audited according to ISAE 3000.
Next step
Bring your quality lead to see what an auditor would see.
A 30 minute demo covering a live discrepancy report, the recording behind it, and where your data is stored.