We unify IoT telemetry, ERP, and eQMS data into one validated decision layer. Deterministic rules make the call. AI drafts the paperwork. Your QA team signs.
The Problem & Solution
Why the gap exists
Telemetry vendors have no ERP. Quality vendors have no telemetry. SAP has neither.
KOOLD is the decision layer between them. Device-agnostic. Scalable, since the data already lives in your systems. Built to support a validated integration against Annex 11 and 21 CFR Part 11.
How KOOLD thinks
One excursion, end to end. The machine reads, decides, and drafts. The qualified person signs, and keeps the liability.
Telemetry from any logger or carrier, harmonized into one validated time-temperature record.
Applies the batch's stability rule. Deterministic, auditable code, not a model.
Blocks the lot in SAP S/4HANA before the goods move on.
AI drafts the deviation and CAPA from validated data. Every claim traceable to source.
The qualified person approves. Decision and liability stay with your team.
Regulatory Excellence
We fulfill pharma-specific regulatory requirements. Every solution is built with compliance at its core.
Good Distribution Practice
Electronic Records
European Standards
Validation Protocols
Every release decision runs on auditable, validated code, not a model. AI is used to draft documentation and surface patterns, never to approve or reject a batch.
Go deeper
Free 30-minute consultation
Schedule a consultation with our cold chain integration experts and discover how we can transform your pharmaceutical operations.