SAP: Life Sciences and Pharma

SAP for life sciences and pharma

SAP that an inspector can follow from raw material to released batch. We implement and migrate SAP S/4HANA for pharma, biotech and medical device companies, connect it to LIMS, MES and serialization, and produce the validation evidence a GxP system needs. Senior SAP and integration engineers own the design, AI coding agents carry the volume, and every line is reviewed by a human.

Get a free SAP assessment Our SAP services

Key highlights

We implement, migrate and support SAP S/4HANA for regulated manufacturing: batch management, QM, process orders, EWM and serialization.
Validation is part of the plan from day one: risk based GxP assessment, requirements traceability, test evidence and change control aligned with GAMP 5.
We integrate SAP with LIMS, MES, electronic batch records, and serialization through SAP Advanced Track and Trace for Pharmaceuticals.
Mainstream maintenance for SAP ECC 6.0 ends on 31 December 2027, and a validated migration needs more lead time than most.
We are an independent engineering team, not an SAP partner. Licences stay with SAP or your reseller.

SAP problems we see in life sciences

In a GxP environment every change to SAP carries validation cost, so systems tend to be left alone long after the business has moved on. That makes the eventual change bigger and riskier.

A validated ECC that nobody wants to touch. ECC 6.0 mainstream maintenance ends at the end of 2027, but every change triggers revalidation, so the migration keeps slipping while the deadline does not.

Batch release held up by paper. QA collects test results from LIMS, deviations from the QMS and batch records from the shop floor before releasing a batch, and SAP status is updated by hand at the end.

LIMS and SAP disagree. Inspection lots, sample results and specifications are maintained in both systems, so a result passes in LIMS while the usage decision in SAP waits for someone to key it in.

Shelf life and expiry managed outside SAP. Retest dates, expiry dates and minimum remaining shelf life checks run in spreadsheets, so stock close to expiry ships to the wrong market or expires in the warehouse.

Serialization as a separate island. Serial numbers and aggregation data live in a line level system with fragile links to SAP deliveries, and every regulatory report or market launch needs manual reconciliation.

Validation documents that do not match the system. Years of small changes mean the specifications, test scripts and the configured system have drifted apart, and an inspection finding is one question away.

Capabilities

Our SAP capabilities for life sciences

We cover the regulated manufacturing and quality processes in SAP and the integrations that make SAP the record for batch status.

Batch management and shelf life

Batch classification, batch status and restricted stock, shelf life expiration and retest dates, minimum remaining shelf life checks on goods receipt and delivery, and full batch where used and where from genealogy.

Quality management and LIMS integration

Inspection plans, inspection lots, results recording and usage decisions in SAP QM, integrated with LIMS such as LabWare, STARLIMS or LabVantage so specifications and results are entered once and flow automatically.

Process orders and MES or eBR

Master recipes, process orders and material staging in S/4HANA, integrated with MES and electronic batch record systems so consumption, yields and deviations post back to SAP against the batch.

Batch release

A release process that gathers LIMS results, deviation status and batch record review before the batch status changes in SAP, using SAP Batch Release Hub for Life Sciences or a workflow built on SAP BTP.

Serialization and traceability

Integration of SAP Advanced Track and Trace for Pharmaceuticals with packaging lines, EWM and S/4HANA deliveries, so serial numbers, aggregation and regulatory reporting stay consistent with batches and shipments.

GxP validation documentation

Risk based validation in line with GAMP 5: user requirements, functional specifications, traceability matrix, IQ, OQ and PQ test evidence and change control records, produced as part of delivery rather than after it.

How we deliver

From validated ECC to validated S/4HANA

01
Assess
We review your system, GxP relevant processes, custom code, interfaces to LIMS, MES and serialization, and the current validation package. Output: a migration approach, GxP risk assessment and validation strategy.
02
Design
Fit to standard workshops for batch, quality and production processes, user requirements and functional specifications written in validation ready form, and a decision on every custom object.
03
Build and migrate
Configuration, interfaces and extensions under change control, executed test scripts with evidence, and data migration of batches, specifications and stock with reconciliation reports for QA sign off.
04
Run and improve
Hypercare, then GxP aware support with change control, periodic review and release upgrade testing. Further sites and processes follow the same validated template.

Compliance and validation in life sciences SAP

SAP is usually a GxP computerised system in a pharma or medical device company. Validation, data integrity and serialization obligations shape how we design, build and support it.

FDA 21 CFR Part 11 EU GMP Annex 11 GAMP 5 risk based validation ALCOA+ data integrity DSCSA (US) serialization EU Falsified Medicines Directive SOX and ITGC controls GDPR and UK GDPR

Electronic records are controlled. Where SAP holds GxP records, we configure audit trails, electronic signatures on usage decisions and batch status changes, role based access and change documents, in line with FDA 21 CFR Part 11 and EU GMP Annex 11.

Validation is risk based and traceable. We follow a GAMP 5 style approach: functions are classified by GxP impact, testing effort is proportional to risk, and every requirement traces to configuration and test evidence your QA team can approve.

Serialization rules drive integration design. US DSCSA and the EU Falsified Medicines Directive require serialised packs and reporting. We design the SAP side of SAP ATTP or your serialization platform so batch, expiry and serial data match across systems and markets.

SAP products and tools we work with

Standard SAP life sciences scope first, with integration tooling that keeps regulated interfaces testable and documented.

SAP S/4HANA (PP-PI, QM, MM, SD) SAP batch management SAP EWM SAP Advanced Track and Trace for Pharmaceuticals SAP Batch Release Hub for Life Sciences SAP BTP and Integration Suite LIMS integration (LabWare, STARLIMS, LabVantage) MES and eBR integration OData, BAPI and IDoc ABAP and ABAP RESTful (RAP) SAP Fiori SAP Datasphere and Analytics Cloud

FAQ

Common questions

Can you migrate a GxP validated SAP system to S/4HANA?

Yes. We treat the migration as a validated change: a GxP risk assessment up front, requirements and specifications in validation ready form, executed test evidence, and data migration reconciliation that QA signs off. Your QA team stays the approver of the validation package.

Does SAP S/4HANA support 21 CFR Part 11?

SAP provides the technical controls, but compliance depends on how it is configured and validated. Audit trails, change documents, electronic signatures and access controls have to be set up and tested for your GxP processes, which is part of our scope.

How do you integrate SAP with our LIMS?

Through standard SAP QM interfaces and SAP Integration Suite or your middleware. Inspection lots and specifications go to the LIMS, results and usage decisions come back, and every message is logged so the interface itself can be validated.

Do we need SAP Advanced Track and Trace for Pharmaceuticals?

Not necessarily. ATTP is SAP's serialization repository and integrates natively with S/4HANA and EWM, but many companies use another serialization platform. We design the SAP side either way so batches, expiry and serial numbers stay consistent.

Are you an SAP partner?

No. RG INSYS is an independent engineering company and does not claim SAP partner status or SAP certifications. You license SAP directly from SAP or your reseller, and we work on your validated system under NDA with full IP assignment.

Can you provide GxP aware SAP support after go live?

Yes. Our application management support works inside your change control process, with impact assessment, test evidence for each change and support for periodic review and upgrade validation.

Keep exploring

Related services and industries

Free consultation, no commitment

Planning a validated S/4HANA move?

Tell us about your sites, GxP scope and SAP landscape. Written scope, timeline and estimate within 48 hours.

Book a free consultation All industries