For Pharma
Batch records assembled as the batch runs. Audit evidence retrieved, not rebuilt.
Every audit triggers a multi-week scramble: batch records, deviation logs, calibration evidence, operator sign-offs, mostly from PDFs, spreadsheets, emails. Revalidation overhead. Risk of gaps. wiseDo builds GMP-aligned evidence from floor data as the work happens, sealed so an inspector can verify it without taking our word for anything.
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The Problem
Every audit is a crisis. Every batch is a manual record.
A customer complaint, a regulatory audit, an internal review: any one of them kicks off the same scramble. Someone digs batch records out of logbooks, deviation logs out of old email threads, calibration evidence out of maintenance files, and operator sign-offs out of people's memory.
Then comes revalidation. New systems, parallel runs, extended qualification. Six months of planning and execution before you can cut over.
Meanwhile, packaging lines run without continuous digital supervision. Gowning compliance relies on spot checks. Deviations get logged days after they happen. Evidence is reconstructed, not captured.
The wiseDo Solution
Continuous digital evidence capture, inside the workflows you already validated.
Batch records, deviation logs, calibration data and the operator audit trail are built from floor data on the validated equipment you already run. wiseDo runs alongside your validated systems rather than replacing them, which keeps the qualification scope to the new layer instead of the whole line — the scope itself is agreed with your QA in the assessment, not assumed here.
When an audit lands, the evidence pack is generated rather than assembled: a sealed record, a deterministic document and a content hash, so the same facts verify twice. Deviations are timestamped and tagged the moment they're caught, not pieced together from memory weeks later. Gowning compliance runs on a detector trained to your gowning standard and admitted through the same sealed release gates as every other model — that training is part of the deployment, not a switch we flip. Full unit-level GMP genealogy is in development.
Deviation logged
Recorded at the moment of detection, with the evidence attached.
Batch record
Assembled from floor data through the batch, not after it.
Audit pack
Retrieved by batch, line or date instead of reconstructed.
How wiseDo is deployed here
Six weeks, step by step.
A packaging or secondary line under GMP, where the record matters as much as the product. Deployment is validated and, where required, air-gapped.
- 1
Process and compliance walk
We walk the line with QA, map each step of the batch traveler, gowning points and deviation triggers, and agree the numbers: audit-prep time, deviations closed on time, batch record completeness.
- 2
Cameras, on-premise, fully offline if required
Cameras cover gowning entry and critical steps. The edge box runs inside your network with no external connectivity when your policy demands it. Video never leaves the site; only events are stored.
- 3
Validation and calibration
Installation and operational qualification are documented. Sight is calibrated on your own footage for gowning compliance and step completion, then confirmed with QA before it counts.
- 4
Batch records build themselves
Each step's completion, operator, timestamp and material lot are captured as the batch runs. The traveler is a live record, not a form filled in afterwards.
- 5
Deviations logged as they happen
A missed step or gowning breach raises a deviation at the moment, with the evidence attached. Investigation starts the same hour, not at batch review.
- 6
Review and scale
At week six: audit-prep hours and deviation closure time against baseline. Additional lines follow under the same validated configuration.
What wiseDo brings
The platform components doing the work.
One platform, one data model. Each component below reads and writes the same event spine, so nothing is re-typed and nothing is reconciled at month-end.
Sight
Gowning compliance and step-completion evidence from cameras, with faces blurred and video kept on site.
PlantOps
GMP-aligned batch travelers, lot genealogy, deviation logs and audit-ready evidence generated in the flow of work.
Air-gapped deployment
Fully on-premise, no external connectivity, complete data control for regulated sites.
Connectivity
ERP and LIMS kept in sync so the batch record and the business record agree.
What changes on your floor
Audit prep stops being a scramble through paper. A deviation is caught in the hour it happens, with evidence, instead of at batch review. And the batch record is complete when the batch is complete.