A studio service
Pharma supply chain apps for SAP S/4HANA where SAP stops, we start.
Your plant runs SAP S/4HANA, and it handles batches, QM release, shelf life, sponsor-supplied stock and planning. We build what sits around it in pharma manufacturing, above all contract manufacturing: a portal for your sponsors, quality notifications, tech transfer, genealogy that runs through MES, LIMS and the courier, cold chain evidence, and screens for the floor and for planners. Each is a separate app beside SAP, connected through released SAP APIs, with an AI layer designed to the draft EU GMP Annex 22.
The facts behind this page
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.”
39 → 111
FDA CDER warning letters on manufacturing or GMP subjects rose from 39 in 2023 to 78 in 2024 and 111 in 2025.
$35 billion
Estimated annual industry-wide losses from failures in temperature-controlled logistics.
FDA, 2016
“Quality agreements should clearly describe the materials or services to be provided, quality specifications, and communication mechanisms between the owner and contract facility.”
26%
In a survey of 100 respondents, 26% named regulatory violations or FDA Form 483 warnings as the main reason a contract manufacturer would lose a bid, ahead of high cost (20%) and timelines (16%).
Draft EU GMP Annex 22
“Generative AI and Large Language Models (LLMs) are not acceptable in critical applications.”
Quoted from the sources linked. We add no estimates of our own.
How it connects
SAP S/4HANA
- Batches, QM, EWM, planning
- Stays the system of record
- Core left standard, nothing changed inside
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
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 does
We don't rebuild SAP. We build what it was never meant to be.
S/4HANA already manages batches, QM inspection lots and usage decisions, shelf life and FEFO in EWM, customer-provided special stock, MRP and IBP planning, and serialisation in ATTP. Joule adds AI assistance inside those workflows.
SAP's own clean-core guidance keeps that core standard and puts portals, third-party services, AI and bespoke analytics in side-by-side extensions. That is all we build: separate apps that read and write SAP through released APIs, upgrade-safe, on SAP BTP or your cloud.
N° 02Built for contract manufacturing
Four things these apps add beside SAP.
01
Visibility for sponsors
Live material, batch and document status per sponsor, without access to anyone else's data.
02
Genealogy beyond SAP
Traces that run through the MES record, LIMS results and courier data, not just SAP goods movements.
03
Cold chain evidence
Logger data matched to SAP deliveries and batches, with excursions assessed and decided on record.
04
A view by sponsor and campaign
Planning and risk shown by sponsor, campaign and date.
N° 03AI, inside the rules
AI that saves time, never a GMP decision.
The draft EU GMP Annex 22 allows only static, deterministic models to support critical decisions, with confidence shown, and keeps generative AI to non-critical work with a person in the loop. Every assist we build sits on the right side of that line: certificate reading and plain-language answers draft for a person to confirm; shortage, lead-time and excursion models are versioned and frozen in use.
N° 04The modules
Nine apps, plus an AI layer.
01
Sponsor portal & client-owned material, from $42,000
A secure portal where each sponsor sees their own material, batches, shipments and released documents, live from SAP, plus a ledger and approvals for sponsor-owned stock.
02
Cross-system batch genealogy, from $36,000
Forward and backward batch genealogy joining SAP batch where-used with MES batch records, LIMS results and shipment data, with timed mock recalls and an inspector view.
03
Cold chain & excursion evidence, from $34,000
Logger data matched to SAP deliveries and batches, excursions assessed against each product's stability budget, and a documented QA decision for every one.
04
Control tower across SAP, MES and LIMS, from $28,000
One live view of inventory, expiry exposure, release cycle time, OTIF and material risk by sponsor, joining SAP with MES, LIMS and logger data, with drill-through to records.
05
GMP warehouse floor app for SAP, from $48,000
A fast, scanner-first warehouse app over SAP EWM or IM: receipt, put-away by storage condition, FEFO picks, cycle counts and status labels, posting to SAP through released APIs.
06
Campaign material planning for SAP, from $38,000
A planner workbench over SAP MRP or IBP for pharma contract manufacturing: material demand by sponsor campaign, expiry-aware netting including quarantine stock, and single-source and long-lead risk.
07
Supplier CoA intake for SAP QM, from $32,000
Certificates of analysis read from PDF, checked against the SAP QM specification and recorded on the inspection lot, plus supplier change notifications with an owner and a decision.
08
Sponsor quality notifications & approvals, from $30,000
For pharma contract manufacturing: deviation and change notifications sent to each sponsor within the quality agreement's deadline, sponsor approvals captured on record, and a clock on every open item.
09
Tech transfer workspace, from $34,000
A shared workspace for bringing a new sponsor process into the plant: transfer package intake, gap and risk tracking, material and specification readiness, and joint sign-off, prepared for SAP master data.
10
AI assist layer, from $24,000
AI assists for SAP-run GMP supply chains, designed to the draft EU GMP Annex 22: static, versioned predictive models with confidence for critical support, generative assists only with a human confirming.
N° 05Investment
Three ways to start.
SAP gap assessment
$9,500
Three weeks to find where SAP stops and what to build first.
- Workshops with supply chain, warehouse, QA, IT and your SAP team
- Map of what SAP already covers and where the gaps are
- User requirements for the first one or two extensions
- Integration and clean-core plan using released SAP APIs
- Fixed price per module; fee credited against the first build
- Not included: any build, changes to your SAP configuration
Sponsor visibility bundle
From $165,000
Sponsor portal, cross-system genealogy and control tower, in production.
- Sponsor portal, cross-system genealogy and control tower at the Production package level
- One shared core: identity, roles, audit trail, SAP connection
- SAP plus one MES or LIMS integration, built once and shared
- Up to three sites and 250 users
- 60 days of hypercare after go-live
- Not included: GxP-ready documentation (quoted per module), AI assists, validation execution, SAP licences
Full extension suite
From $420,000
All nine modules plus the AI assist suite, rolled out in phases.
- All nine modules at the Production package level
- AI assist suite: three assists across the modules
- Phased roadmap, one module live at a time
- Quarterly roadmap and model review for the first year
- Not included: GxP-ready documentation (quoted per module), validation execution, SAP licences, hosting costs
Before you buy
What you get
- Independent apps that connect to SAP only through SAP's released APIs
- Read-only Pilots that create nothing in SAP, so they carry 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
- Patient-level chain of identity for cell and gene therapy, which SAP's own orchestration product covers
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° 06Questions
The answers we give most often.
- We run SAP. Why would we need this?
- You shouldn't replace any of it. SAP handles batches, QM release, shelf life, customer-provided stock and planning. These apps add what sits around it in contract manufacturing: a portal for your sponsors, genealogy that crosses into MES, LIMS and courier data, cold chain evidence, a sponsor-level control tower, and scanner and planner screens.
- Does this go against clean core?
- No, it follows it. SAP's clean-core guidance keeps the S/4HANA core standard and puts portals, third-party services, AI and bespoke analytics in side-by-side extensions that use released APIs. That is how every module here is built.
- Where do the extensions run?
- On SAP BTP using SAP's Cloud Application Programming Model, or in your Azure or AWS tenancy if that is your standard. EU and Swiss data residency are available either way.
- How do you use AI in a GMP plant?
- To the draft EU GMP Annex 22. Predictive models that support critical decisions are static, versioned and show their confidence. Generative AI is used only in non-critical work, drafting for a person to confirm. No AI output releases, rejects or ships a lot.
- How does this sit with SAP Joule?
- Side by side. Joule assists inside SAP workflows. Our assists work on data held outside SAP, such as supplier PDFs, MES, LIMS and logger data, and on the sponsor and campaign view.
- 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.
- Will this add SAP licence costs?
- Reading data from SAP does not. When an outside app creates documents in SAP, such as goods movements, SAP's Digital Access licence can apply. Pilots are read-only for that reason, and before any two-way build we check the position with your SAP licence team.
- Do you cover cell and gene therapy chain of identity?
- No. SAP sells its own orchestration product for patient-level chain of identity and chain of custody, and that is the right tool for it. Our apps cover the sponsor, quality, genealogy and cold chain work around it.
- Are the modules validated?
- We build to GAMP 5 Category 5 and, in the GxP-ready package, deliver the development documentation and executed developer test evidence. Validation execution and sign-off stay with your QA and CSV team.
- Can we start small?
- Yes. Start with a Pilot of one module on one site, read-only from SAP, live in eight to ten weeks.
N° 07Related
- Sponsor portal & client-owned material
- Cross-system batch genealogy
- Cold chain & excursion evidence
- Control tower across SAP, MES and LIMS
- GMP warehouse floor app for SAP
- Campaign material planning for SAP
- Supplier CoA intake for SAP QM
- Sponsor quality notifications & approvals
- Tech transfer workspace
- AI assist layer
- Security, validation & your SAP partner
Start your book
Running SAP S/4HANA in a pharma plant?
Tell us your SAP landscape, your sites and what you need beside it. We'll reply with an assessment plan and fixed prices within two business days.