DesignKompanie

A studio service

Sponsor portal for pharma contract manufacturing your clients see their own material and batches, live.

A sponsor portal answers the question every client asks: where are my material and my batches? We build sponsor portals that read live from SAP, MES and your document system, show each sponsor only their own data, and handle the sponsor-owned material that sits in your warehouse, including approvals to scrap, return or transfer it.

Sponsor portal for pharma contract manufacturing

The facts behind this module

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.”
Source: US FDA, Contract Manufacturing Arrangements for Drugs: Quality Agreements (November 2016).

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%).
Source: ISR, Bioprocessing Market Outlook 2025–2030 (Q3 2025, n=100), as reported by PharmaSource.

39 → 111

FDA CDER warning letters on manufacturing or GMP subjects rose from 39 in 2023 to 78 in 2024 and 111 in 2025.
Source: US FDA CDER data, as reported by PharmaSource.

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

What it looks like

Sponsor portal — Northfield Bio (sample sponsor)

Lots on site

42

Batches in progress

3

Awaiting QA release

2

Open approvals

1

BatchProductStageStatusDocuments
B-24071NB-101 drug substancePurificationOn time—
B-24068NB-101 drug substanceQC testingIn QCCoA pending
B-24062NB-101 drug substanceReleasedReleasedCoA, batch record
B-24055NB-204 drug productShippedReleasedCoA, shipping record

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 tracks sponsor-supplied material as special stock and knows each batch's status. This module adds the sponsor-facing portal on top. 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.

01

Status updates by email and spreadsheet

Status reports assembled by hand for each sponsor are replaced by a live view.

02

Sponsor-owned stock in a general ERP view

Ownership and segregation rules on every lot, with a ledger per sponsor reconciled to SAP special stock.

03

Disposal approvals lost in inboxes

Scrap, return and transfer requests routed to the sponsor's named approver, decided and recorded against the lot.

04

Documents sent one by one

Released CoAs and batch documents available to the sponsor as soon as QA releases them.

N° 03What the module covers

Scope, in plain terms.

01

Sponsor portal

Each sponsor sees their own stock, batch status, shipments and released documents. Nothing else, enforced at the data layer.

02

Ownership ledger

Sponsor-owned and consigned material by lot, reconciled to SAP customer-provided special stock.

03

Approvals

Disposal, return and transfer requests with the sponsor's decision recorded.

04

Monthly statements

Stock statements per sponsor generated from the ledger, ready to send.

N° 04For each person in the decision

One page, six readers.

01

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.

02

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.

03

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.

04

Sponsor-facing teams

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

05

Procurement

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

06

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.

01

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.

02

Weeks 3–5: build

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

03

Weeks 6–7: your data

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

04

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.

01

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.

02

Buy a packaged product

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

03

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.

01

Plain-language status answers

Sponsors ask "where is campaign 3?" and get an answer drawn only from their own records, with links to the records. Generative, non-critical, every answer sourced.

02

Status summaries for account managers

A weekly draft of what changed for each sponsor, reviewed by the account manager before it goes out.

N° 08Investment

Pilot, production, or GxP-ready.

Pilot

From $42,000

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

  • Portal with stock and batch status for up to three sponsors
  • Ownership ledger reconciled to SAP special stock
  • 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 $68,000

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

  • Everything in Pilot
  • Approvals workflow and monthly statements
  • Document links from your QMS or DMS for released certificates
  • 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 $104,000

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.

Why not use an SAP portal product?
You can, and some plants do. A side-by-side portal on BTP or your cloud reads live through SAP APIs, is designed for sponsors rather than buyers, and changes on its own release cycle without touching the SAP core.
How is one sponsor kept from seeing another's data?
Every record carries the sponsor and the portal enforces it in the data layer, not only in screens. Access is reviewed and logged.
Does the AI see other sponsors' data?
No. The assistant can only read records the signed-in sponsor is already allowed to see, and every answer links to its source.
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.

Start your book

Planning the Sponsor portal & client-owned material 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.

Sponsor Portal for Pharma Contract Manufacturing