Regulated cold chains are governed by a handful of overlapping frameworks. Each one asks the same underlying question — can you prove that temperature-sensitive products stayed within range, and can you produce the records on demand?
This compliance hub explains what each regulation requires in plain English, exactly how Seemoto's wireless monitoring supports it, and — importantly — which capabilities are included in a standard monitoring subscription versus which are separate professional services. Seemoto supports the requirements these frameworks enforce; it does not replace your own quality system, and it is not a substitute for formal validation.
Good Distribution Practice
Good Distribution Practice (GDP) is the set of standards that governs how medicinal products are stored, transported and handled across the distribution chain so their quality and integrity are maintained from manufacturer to patient.
How Seemoto supports GDP →Good Manufacturing Practice
Good Manufacturing Practice (GMP) is the quality framework ensuring that medicinal and other regulated products are consistently produced and controlled to the standards appropriate to their intended use, including environmental monitoring of production and storage areas.
How Seemoto supports GMP →Hazard Analysis and Critical Control Points
HACCP (Hazard Analysis and Critical Control Points) is a systematic, preventive food-safety management system that identifies hazards and controls them at the critical control points where temperature monitoring is essential.
How Seemoto supports HACCP →EN 12830 — Temperature Recorders
EN 12830 is the European standard that specifies the performance, testing and suitability requirements for temperature recorders used in the transport, storage and distribution of temperature-sensitive goods such as food and pharmaceuticals.
How Seemoto supports EN 12830 →FDA 21 CFR Part 11 — Electronic Records & Signatures
FDA 21 CFR Part 11 is the US Food and Drug Administration regulation that defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable and equivalent to paper records.
How Seemoto supports FDA 21 CFR Part 11 →A note on how we talk about compliance
Seemoto is designed and built to support regulated environments. The platform supports the requirements of GDP, GMP, EN 12830, HACCP and FDA 21 CFR Part 11 through continuous automated monitoring, tamper-evident audit trails and compliance-ready reporting.
We are deliberately precise: supporting a framework is not the same as being "certified" or "validated" against it. Formal validation (IQ/OQ/PQ) and signed report packages are separate professional services, and the exact documentation scope is always confirmed during project scoping.
Map your requirements to a solution
Talk to our team about your compliance goals and we'll recommend the right monitoring setup and documentation scope.
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