EU GDP · MHRA GDP · WHO TRS 961/992 · Cold chain
GDP cold chain software with qualified lanes, MKT and RP oversight as one system.
EU 2013/C 343/01 and MHRA GDP put the Responsible Person on the hook for lane qualification, continuous temperature monitoring, MKT calculation, deviation handling and returned-goods disposition — for products moving between 2–8°C, 15–25°C and controlled ambient. V5 replaces the four spreadsheets and the data-logger emails with one cockpit the RP can defend on inspection day.
Qualified lane library (OQ/PQ)
Continuous Monitoring + MKT
Excursion-to-Disposition Workflow
Returned Goods & Falsified Medicines
Full product detailCommon problems, what's included, why teams choose it, and where commercial meets regulated.
You're shopping because the last excursion took a week to disposition and the RP had to defend a spreadsheet.
Temperature loggers dump CSVs the QA team stitches together by hand
Lane qualification (OQ/PQ) lives in a binder the freight forwarder can't reproduce
Excursion-to-disposition takes days because product, logger and CoC data live in three systems
Returned goods sit in quarantine with no linked risk assessment
The RP has no single dashboard for lanes, deviations and CAPAs
GDP, run as one Responsible Person cockpit.
Qualified lane library (OQ/PQ)
Each lane (origin, destination, mode, packaging, season) is a qualified object with OQ/PQ evidence, revalidation triggers on route/carrier/packaging change, and a per-shipment link to the lane version in effect.
Continuous Monitoring + MKT
Logger ingest (Berlinger, ELPRO, Sensitech, Controlant, etc.), continuous excursion detection against product-specific limits, MKT calculation on the correct Ea (default 83.144 kJ/mol) with per-product override and audit trail.
Excursion-to-Disposition Workflow
Quality decision (release, quarantine, reject) with electronic signature and CoC — hours, not days.
Returned Goods & Falsified Medicines
Structured returned-goods intake with tamper-evidence check, FMD (EU 2016/161) verify/decommission API for saleable returns, and disposition trail per GDP Chapter 6.3.
Responsible Person Cockpit
RP dashboard: active lanes and status, open excursions by aging, CAPA burn-down, RP delegate log, temperature mapping refresh dates, and self-inspection schedule per Chapter 6.
Self-Inspection + Supplier/Customer Qualification
Chapter 6 self-inspection programme with findings tied to CAPA. Supplier (wholesale authorisation, GMP/GDP status) and customer (bona-fide check) qualification refreshed on cadence.
What changes the day this goes live.
- Lane qualification is a live library, not a binder
- MKT calculation is defensible and re-runnable to the second
- Excursion-to-disposition happens in hours, not days
- Saleable returns clear FMD before touching sellable stock
- The RP owns one cockpit, not four spreadsheets
The frameworks a wholesale distribution authorisation holder owns.
EU GDP (2013/C 343/01)
Chapters 1–9: quality system, personnel and RP, premises and equipment, documentation, operations, complaints/returns/falsified/recalls, outsourced activities, self-inspection, transportation.
MHRA GDP + WHO TRS 961/992
Post-Brexit MHRA GDP guidance and WHO good distribution/storage practices — including annex on temperature-controlled products and TRS 961 Annex 9 on time and temperature.
EU FMD (2016/161)
Unique identifier verify/decommission at dispensing and for saleable returns, integrated with the national medicines verification system (NMVS/EMVS).
GDP cold chain software, answered.
How does V5 calculate MKT?
MKT is calculated with the Haynes equation using the product-specific activation energy (default 83.144 kJ/mol per USP <1079> guidance) over the interval defined by the product's stability profile. Each MKT value is signed, timestamped, and re-runnable against the raw logger data — no black-box result.
Which logger vendors are supported?
V5 ingests Berlinger, ELPRO, Sensitech, Controlant, DeltaTrak, Emerson and any logger that produces CSV/PDF/JSON exports through the ingest connector. New vendors are typically added in days by mapping fields, no code change.
Does V5 handle FMD for saleable returns?
Yes. Returned packs are checked against the national verification system, the disposition is recorded, and only packs verified as active and within the FMD reactivation window are returned to sellable stock. All others go to disposition per GDP Chapter 6.3.
What does the Responsible Person actually see?
One dashboard: active lanes and their qualification status, open excursions by aging bucket, CAPA burn-down, self-inspection schedule, supplier/customer qualification currency, and a signed delegate log for any action taken on the RP's behalf.
Capabilities vary by plan and setup. Confirm specifics with our team before relying on them.
Run GDP on one qualified-lane cockpit.
Free trial. Real loggers, real MKT, real RP dashboard.