Which loggers do you support?

Any provider with an API or export; common ones such as Sensitech, ELPRO and Controlant are built once and reused.

Does the AI release product?

No. It scores risk and drafts the assessment. QA makes and signs the decision, as Annex 22 expects.

Storage as well as transport?

Yes; warehouse and fridge monitoring feed the same stability budget.

Are you an SAP partner?

No. We are an independent studio. We build beside SAP using its released APIs and work with your SAP partner, who stays responsible for SAP itself. If you need the integration certified by SAP, we scope that into the project.

A studio service

Cold chain & temperature excursion management for SAP from the freezer to the receiving dock.

Temperature data lives in the logger provider's portal and the batch lives in SAP. We join them: every shipment tied to its loggers and its SAP delivery and batches, data pulled on arrival, each excursion compared with the product's allowable time out of range, and each one routed to a recorded QA decision.

See the packages →All supply chain modules

Cold chain & temperature excursion management for SAP

The facts behind this module

$35 billion

Estimated annual industry-wide losses from failures in temperature-controlled logistics.

Source: IQVIA Institute for Human Data Science (2019), as reported by Veratrak.

21 CFR 211.150(b)

Distribution procedures shall include “a system by which the distribution of each lot of drug product can be readily determined to facilitate its recall if necessary.”

Source: US FDA, 21 CFR 211.150(b).

62%

“Of 163 drugs that went into shortage between 2013 and 2017, 62 percent went into shortage after supply disruptions occurred that were associated with manufacturing or product quality problems.”

Source: US FDA, Drug Shortages: Root Causes and Potential Solutions (2019, updated 2020).

Quoted from the sources linked. We add no estimates of our own.

What it looks like

Shipments — temperature status

In transit

Excursions open

Awaiting QA decision

Budget used, worst lot

62%

Shipment	Batch	Lane	Range	Time out of range	Status
SH-7781	B-24062	Plant A → Boston	2–8 °C	0 h	In range
SH-7779	B-24055	Plant A → Singapore	2–8 °C	3 h 10 m	Excursion
SH-7774	B-24049	Plant B → Dublin	−70 °C	0 h	In range
SH-7770	B-24041	Plant A → Tokyo	2–8 °C	0 h 40 m	Review

Interface concept with invented sample data, shown to illustrate the design. It is not a screenshot of a live system.

How it connects

SAP S/4HANA

Batches, QM, EWM, planning
Stays the system of record
Core left standard, nothing changed inside

⇄released APIs only

The app, in your tenancy

SAP BTP, Azure or AWS, your region
Audit trail, roles, single sign-on
Read-only in a Pilot; write-back by agreement

⇄scoped access

People and plant systems

Your teams, by role
Sponsors, each to their own data
MES, LIMS, QMS and logger platforms

SAP's clean-core rule, quoted: “Extensions must be developed using only released local or remote public SAP APIs, BAdIs, or ABAP RESTful application programming model business object (BO) extension points.” SAP PRESS, SAP S/4HANA Clean Core: Principles, Benefits, and Best Practices.

N° 01What SAP already covers

We start from SAP, not against it.

SAP knows the delivery, the batch and its status. This module adds logger data, cumulative time out of range and the excursion assessment. This module is a side-by-side extension: it reads and writes SAP only through released APIs and leaves the core standard.

N° 02Where it helps

Four situations this module is built for.

Logger data nobody pulls

Pulled automatically and matched to the SAP delivery and batches.

Excursions judged by email

Compared with stability data, routed to QA, decided and recorded.

Stability budget in a binder

Cumulative time out of range per batch, from warehouse to receipt.

The same lane failing again

Excursion rates by lane, carrier and packaging.

N° 03What the module covers

Scope, in plain terms.

Shipments & loggers

Loggers linked to SAP deliveries and batches.

Excursion workflow

Detection, assessment, QA decision, record; SAP batch status updated through the API on decision.

Stability budget

Cumulative time out of range per batch.

Lane performance

By lane, carrier and packaging configuration.

N° 04For each person in the decision

One page, six readers.

Supply chain lead

The scope above, three fixed-scope packages with prices, and a read-only Pilot you can run on one site before committing.

QA and validation

GAMP 5 Category 5 development documents, executed developer IQ/OQ evidence, Annex 11 and Part 11 controls in the GxP-ready package. You run and sign validation.

IT and your SAP team

Released SAP APIs only, no changes inside SAP, one least-privilege technical user, deployed in your own tenancy and region.

Sponsor-facing teams

Each sponsor sees only their own data, enforced in the data layer, with every access logged.

Procurement

Fixed scope and price per package, a written not-included list, and our vendor questionnaire answered in full on request.

Finance

The price shown is ours. SAP licences, including any SAP Digital Access for documents created in SAP, hosting and validation effort are yours and are listed as not included.

N° 05The Pilot, week by week

Eight to ten weeks, read-only from SAP.

Weeks 1–2: scope and access

Requirements workshop, the list of SAP APIs to be read, a technical user from your SAP team, and sample data agreed.

Weeks 3–5: build

The module built in your tenancy against your SAP test system, with a working demo every week.

Weeks 6–7: your data

Connected to the agreed SAP data, tested by your users, findings fixed.

Weeks 8–10: live on one site

Go-live for up to 25 users, a handover session, and a written decision paper for the Production package.

N° 06Your three options

Inside SAP, packaged, or beside SAP.

Customise inside SAP

Done by your SAP partner. SAP's clean-core rule limits extensions to released APIs and extension points, and each change follows your SAP change and validation process.

Buy a packaged product

A vendor's standard product and roadmap, with its own licence, validation package and integration to your SAP.

Build beside SAP (this page)

An app scoped to your process, in your tenancy, connected through released SAP APIs, with the source code and documentation handed to you.

N° 07AI assists

Where AI helps, and where a person decides.

Designed to the draft EU GMP Annex 22: predictive models are static, versioned and show their confidence; generative tools only draft for a person to confirm. No assist releases, rejects or ships a lot.

Lane risk score

A static, versioned model scores each planned shipment for excursion risk by lane, season and packaging, with confidence, so planners can change packaging before it ships.

Excursion pre-assessment

A draft assessment comparing the excursion with stability data, for QA to confirm or overrule. QA decides and signs.

N° 08Investment

Pilot, production, or GxP-ready.

Pilot

From $34,000

One site, read from SAP through released APIs, live in 8–10 weeks.

Logger data from one provider matched to SAP deliveries
Excursion detection and stability-budget tracking
Read-only connection to SAP S/4HANA (OData APIs and CDS views), no core changes
Audit trail on every record, role-based access, SSO with your identity provider
One site, up to 25 named users
Not included: write-back to SAP, electronic signatures, validation documentation, SAP BTP licences

Start the project

Recommended

Production

From $56,000

Two-way with SAP and one more plant system, across sites.

Everything in Pilot
QA decision workflow writing batch status back to SAP
Second logger provider or 3PL feed
Two-way integration through SAP APIs or SAP Integration Suite, clean-core compliant
Digital Access check with your SAP licence team before any write-back is switched on
Up to three sites and 250 users
60 days of hypercare after go-live
Not included: validation documentation, SAP or BTP licences (including any SAP Digital Access your contract requires for documents created in SAP), SAP-side configuration by your SAP partner

Start the project

GxP-ready

From $88,000

Built and documented for GMP use.

Everything in Production
21 CFR Part 11 / EU Annex 11 electronic signatures and record controls
GAMP 5 Category 5 SDLC pack: URS trace matrix, FS/DS, code review records
IQ/OQ scripts with executed developer evidence; change control for later releases
Not included: validation execution and QA sign-off (your CSV team), hosting qualification, SAP licences

Start the project

Before you buy

What you get

An independent build that connects to SAP only through SAP's released APIs
A read-only Pilot that creates nothing in SAP, so it carries no SAP licence exposure
Delivery alongside your SAP partner and IT, who keep control of SAP itself

What we don’t do

SAP licences, or SAP Digital Access for documents a two-way build creates in SAP
Changes to your SAP configuration or custom code inside SAP
SAP certification of the integration, unless you ask us to scope it in

DesignKompanie is an independent studio and is not affiliated with, endorsed by or a partner of SAP SE. SAP and SAP S/4HANA are trademarks of SAP SE.

N° 09Questions

The answers we give most often.

Which loggers do you support?: Any provider with an API or export; common ones such as Sensitech, ELPRO and Controlant are built once and reused.
Does the AI release product?: No. It scores risk and drafts the assessment. QA makes and signs the decision, as Annex 22 expects.
Storage as well as transport?: Yes; warehouse and fridge monitoring feed the same stability budget.
Are you an SAP partner?: No. We are an independent studio. We build beside SAP using its released APIs and work with your SAP partner, who stays responsible for SAP itself. If you need the integration certified by SAP, we scope that into the project.

N° 10Related

Start your book

Planning the Cold chain & excursion evidence build?

Tell us your sites, the systems you run and what has to change. You'll get a scoped plan and a fixed price within two business days.

Start the project See the process