Manufacturing & industry · Pharmaceuticals
GMP discipline, extended to every camera.
Extend GMP discipline to every camera: gowning verification, cleanroom zone control, line clearance, and cold-chain monitoring, with sealed, audit-grade evidence your quality and regulatory teams can stand behind.
In pharmaceuticals
What goes wrong today.
Gowning deviations surface in batch review, too late
A missed glove or mask discovered weeks later can put an entire batch in question. Detection needs to happen at the door.
GMP evidence is assembled by hand
Deviation reports, line-clearance records, and inspection responses are stitched together from logs and interviews.
Line clearance depends on human sign-off
Changeover verification is a checklist and a signature. Visual proof that the line was actually clear rarely exists.
Detect · Step 1 of 4
What the cameras watch for.
Deploys outside the validated envelope: reads camera streams without touching GMP-qualified systems.
Sealed evidence
Ostmere Foods Packing Plant
Demo footage, annotated the way FloFrame does. Each card appears as its alert is raised.
Gowning & hygiene compliance
Verify gowning, gloves, and masks at cleanroom entries: every entry, every shift.
Cleanroom zone control
Enforce personnel limits and movement rules across grade-classified areas.
Line clearance verification
Visual confirmation that lines are cleared between batches, with sealed evidence.
Cold-chain & storage watch
Monitor storage areas, door states, and handling practices around sensitive product.
Material flow integrity
Track material movement against defined routes to prevent mix-ups.
GMP audit evidence
Every deviation logged, explained, and exportable for inspections.
Rules
Rules you would run.
Written in plain words, run on site, checked by a vision model before anyone is alerted.
Gowning compliance
“Full gowning (suit, gloves, mask) before entering Grade B”
Then: ENTRY FLAGGED · QA NOTIFIED
Open in the Rule PlaygroundLine clearance
“Confirm the line is clear of components before batch changeover”
Then: CLEARANCE LOGGED · EVIDENCE SEALED ✓
Open in the Rule PlaygroundZone occupancy
“No more than 4 people in the filling suite at any time”
Then: QA ALERTED · DEVIATION LOGGED
Open in the Rule Playground
Measure · Step 2 of 4
Every alert becomes a number you manage.
What FloFusion measures for Pharmaceuticals, per zone, per site and over time.
Line staffing
People at each station and bay, against the crew the line was planned for.
Time at station
How long operators stay at each station, and where stations sit empty.
Guard-zone near misses
Reaches into guarded zones while the line runs, per hour watched.
What a pilot sets out to move
- deviation detection
- Real-time
- at the door, not in batch review
- of cleanroom entries verified
- 100%
- every entry, every shift, evidenced
- to answer an inspector
- Hours
- sealed deviation records on demand
Pilot targets agreed with you up front, not past results.
Comply · Step 3 of 4
Proof that holds up with auditors.
The rules that apply to Pharmaceuticals, scored continuously from camera evidence, with a signed record anyone can verify.
EU AI Act
AI used for workplace monitoring and safety is high-risk: you must run risk management, keep event logs, maintain technical documentation, and guarantee human oversight and accuracy monitoring.
GDPR
Video of people is personal data: you need a lawful basis, data minimization, retention limits, and a DPIA for systematic monitoring of workspaces.
UK GDPR and Data Protection Act 2018
Video of identifiable people is personal data: you need a lawful basis, transparency, data minimisation and retention limits, and a DPIA before systematic monitoring of staff.
ICO guidance on monitoring workers
Monitoring must be necessary, proportionate and open: tell workers what you monitor and why, consult them, choose the least intrusive means, and avoid covert monitoring.
Improve · Step 4 of 4
What to change next.
The process map shows where the line is short of hands and where people reach into moving parts.
Rebalance bays across shifts
Move an operator to the bays the map shows unattended at peak.
Guard the capper infeed
Add a fixed guard where reaches into the bottle stream repeat.
Examples of what a pilot’s process map points to.
Getting started
A pilot on the cameras you own.
Prove gowning verification, cleanroom zone control, and line-clearance evidence in one facility: GMP-aligned, on your existing cameras, with sealed records your quality unit can stand behind.
Scope
- Cleanroom entries and gowning areas (gowning and hygiene verification)
- Grade-classified zones (personnel limits and movement rules)
- Packaging and filling lines (line clearance between batches)
- Warehouses and cold storage (door states, handling practices)
We configure
- Plain-English rules mapped to your SOPs: gowning, zone limits, and clearance checks
- FloFrame on-prem inference, so video never leaves your validated environment
- AI event narratives written in your own quality-policy language
- FloFusion deviation logs and GMP-aligned evidence exports for inspections
You walk away with
- Documented gowning-compliance rate at every cleanroom entry
- Sealed line-clearance evidence for every batch changeover in scope
- Deviation records with visual evidence, ready for QA review and inspections
Questions
Pharmaceuticals: common questions.
Can this run inside a GMP-validated environment?
Yes. FloFrame sits beside your infrastructure without touching validated equipment. Rules are explicit and versioned, so your quality team can document exactly what fires and why.
Link to this questionHow does gowning verification work without slowing down entry?
Cameras at gowning areas check gowns, gloves, masks and goggles as people pass. Nothing blocks the door: an exception creates an alert with its clip.
Link to this questionCan we use the recordings as GMP deviation evidence?
Yes. Each alert is sealed on the device, verified on arrival, and carries its clip, rule and review. You can export it for CAPA, QA review and inspections.
Link to this questionDoes patient or operator privacy become an issue?
No identification is involved: rules ask whether a person is gowned or a zone is over its limit, not who it is. Video is processed on site and stays inside your network.
Link to this questionWhat do pharma teams typically start with?
Gowning at cleanroom entries and line clearance on one or two packaging lines. Then measure the trend, score it in a pack such as ISO 13485, and add zone occupancy and material flow on the same cameras.
Link to this questionHow long does a pilot take in a regulated facility?
The install takes days; change control takes most of the calendar. We provide the architecture, data flows and rule definitions your IT, QA and compliance teams need.
Link to this questionHow do we show a record was not edited later?
Evidence is sealed on the device and checked when it arrives. Compliance scores are signed, hash-chained snapshots, so anyone can verify that a record is unchanged.
Link to this questionSee it on your own cameras.
A demo on footage from an operation like yours, then a pilot on the cameras you own.