TAP for Pharmaceutical
Compliance you can prove.
Continuous temperature mapping, cleanroom monitoring, and excursion management — with a 21 CFR Part 11 audit trail built in.
The Problem
What it costs you today.
The gaps a modern operation can no longer afford to leave open.
Excursions caught too late
A cold-chain deviation discovered at the next manual round can mean a rejected batch — and a written explanation you can't fully reconstruct.
Logs are on paper
Manual round sheets are labour-heavy, easy to miss, and painful to produce when an auditor asks for the last twelve months.
Audit exposure
Without a tamper-evident trail of who saw what and when, every inspection is a scramble for evidence.
The Solution
Continuous monitoring, audit-ready by design.
TAP watches every mapped point continuously, alerts on the first sign of an excursion, and records an immutable, signed history for inspection.
- Temperature & humidity mapping across chambers and stores
- Cleanroom monitoring — particle count, RH, differential pressure
- Excursion detection with escalation and acknowledgement
- 21 CFR Part 11 audit trail and electronic signatures
- Tamper-evident history with full change tracking
- Scheduled compliance reports for QA and inspection
Capabilities
What TAP delivers.
The full toolkit, tuned to the metrics that matter in your operation.
Temperature mapping
Continuous monitoring of every mapped point in chambers, cold rooms, and stability stores.
Cleanroom monitoring
Particle count, relative humidity, and room-to-room differential pressure, watched in real time.
Excursion management
Instant alerts on the first breach, with escalation, acknowledgement, and root-cause capture.
21 CFR Part 11
Immutable audit trail, access controls, and electronic records aligned to Part 11 expectations.
E-signatures
Signed acknowledgements and approvals bound to the record they act on.
Compliance reports
Scheduled, inspection-ready summaries for QA — generated, not assembled by hand.
Continuous monitoring
Sensor-to-screen latency
Digital, signed records
Paper round sheets
Typical Deployment
Built for the audit.
Cold rooms, stability chambers, and cleanrooms on continuous watch — with a signed, tamper-evident history ready to hand an inspector on request.
See a pharmaceutical demo.
We'll show TAP running with data like yours — and answer whether it fits your specific setup.