A studio service
Tech transfer workspace for pharma manufacturing from the sponsor's package to a ready-to-run campaign.
A tech transfer brings a new sponsor's process into the plant. The package arrives as many documents, materials need sourcing and specifications, and nothing can run until SAP has the materials, bills of materials and recipes. We build a workspace where both sides see one plan: what has been received, what is open, which materials and methods are ready, and what is still blocking the first batch.
The facts behind this module
> $5 million
“A single tech transfer typically costs more than $5 million.”
18–30 months
A tech transfer “can take 18 to 30 months to complete.”
FDA, 2016
Written agreements should “describe how changes to processes, equipment, methods, and specifications will be managed.”
Quoted from the sources linked. We add no estimates of our own.
What it looks like
Package items
146
Accepted
118
Open queries
17
Days to first batch
84
| Item | Area | Owner | Due | Status |
|---|---|---|---|---|
| Process description v3 | Process | Sponsor | 8 Oct | Accepted |
| Analytical method: potency | QC | Plant | 15 Oct | Query |
| Resin specification | Materials | Plant | 20 Oct | Open |
| Bill of materials for SAP | Master data | Plant | 1 Nov | Draft |
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
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 covers
We start from SAP, not against it.
SAP holds the result of a transfer: material masters, bills of materials, recipes and inspection plans. The transfer itself, the package, the gaps, the readiness tracking and the joint sign-off, runs in documents and spreadsheets outside it. 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
The package is a folder of PDFs
Each item in the transfer package tracked as received, reviewed, queried or accepted.
02
Gaps found late
Gaps and risks logged with an owner on each side and a date.
03
Materials not ready when the suite is
Every material's sourcing, specification and qualification status in one list.
04
Master data typed in at the end
Materials, bills of materials and recipe steps prepared in the workspace and handed to your SAP team in the format they load.
N° 03What the module covers
Scope, in plain terms.
01
Package intake
Checklist of the transfer package with status per item and document links.
02
Gaps & risks
Joint gap assessment and risk register with owners and dates.
03
Readiness board
Materials, methods, equipment and documents by readiness, against the first batch date.
04
Sign-off
Stage gates with sign-off from both the sponsor and the plant.
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
Package reading
Parameters, materials and specifications pulled out of the sponsor's documents into the checklist for a person to confirm. Generative, non-critical, nothing is accepted unconfirmed.
02
Material match
A static model suggests which of the sponsor's materials match materials you already hold qualified in SAP, with confidence, for a person to confirm.
N° 08Investment
Pilot, production, or GxP-ready.
Pilot
From $34,000
One site, read from SAP through released APIs, live in 8–10 weeks.
- Package intake, gap log and readiness board for one transfer
- Existing materials and suppliers read from SAP to show what is already qualified
- 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
Production
From $56,000
Two-way with SAP and one more plant system, across sites.
- Everything in Pilot
- Sponsor access through the portal with stage-gate sign-off
- Master data export in your SAP team's load format for materials, BOMs and recipes
- 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
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
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.
- Does it create SAP master data itself?
- No. It prepares the data and exports it for your SAP team to review and load, so master data governance stays where it is.
- Do sponsors use it too?
- Yes. Sponsors get scoped access to their own transfer: the package status, open questions and sign-offs.
- Is it GxP?
- The workspace supports a GMP process and is built as a project tool by default. The GxP-ready package exists if you use its records as evidence.
- 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
- Pharma supply chain apps for SAP S/4HANA
- Security, validation & your SAP partner
- 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
- AI assist layer
- Enterprise app development
Start your book
Planning the Tech transfer workspace 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.