Compliant SAP S/4HANA Upgrade with Rephine

Upgrade to SAP S/4HANA with confidence. Rephine offers tailored validation solutions for pharma, biotech, and medical devices, ensuring compliance and data integrity.

SAP’s 2027 deadline for S/4HANA migration is approaching fast.

Are you ready to ensure compliance, data integrity, and business continuity?

Embrace the Future of SAP with Confidence

SAP is one of the most widely implemented ERP systems in the Life Sciences industry, enabling businesses to manage critical processes such as materials management, procurement, production, quality, sales, and distribution.

To stay ahead, SAP recommends periodic upgrades to benefit from system improvements and ensure continued support. SAP has announced that companies must transition to its latest version, SAP S/4HANA®, which runs on its proprietary HANA® database, before the end of 2027.

sap upgrade hero image

At Rephine, we specialise in end-to-end validation services for life sciences ERP upgrades, ensuring that your transition to SAP S/4HANA is fully validated, risk-free, and regulatory compliant.

With our deep expertise in global regulatory standards (FDA, EMA, MHRA), we offer tailored validation strategies designed specifically for pharmaceutical, biotech, and medical device companies.

Why Rephine?

With over 150 successful ERP validation projects, including numerous SAP HANA upgrades, Rephine brings extensive expertise to ensure a smooth, compliant, and risk-mitigated transition.

We understand the complexities and regulatory requirements surrounding ERP upgrades — especially in GxP-regulated environments. Our proven approach ensures that your SAP S/4HANA upgrade is validated effectively, safeguarding data integrity and business continuity.

 

Change Assessment

This exercise consists of a documented assessment where the impact of the change is analyzed from the perspective of computer system elements such as: infrastructure, software, data, governance, …

Risk Assessment

Based on the Change Assessment exercise, the potential risks of non-compliance should be identified to determine the aspects where the validation activities should focus.

Test plan

Testing activities should include:

  • Installation Qualification (IQ) where testing activities will be carried out to characterize and to verify the correct installation and configuration of the hardware/software components of the SAP S/4 HANA infrastructure.
  • Operational Qualification (OQ) where the functional verification of changes in the system functionality will be conducted, as well as verifications to demonstrate that the new system version operates as the replaced version and without including risks of GMP non-compliance.
  • Data Migration Verification which will ensure that the source data is properly migrated to the new database, this activity being especially relevant since the migration is related with critical GMP data.
  • Performance Qualification (PQ), which will allow demonstrating that the new system version is capable of performing the processes as required by the company and under the final operating environment.

What Sets Rephine Apart?

REPHINE PURPLE ACCENT STAFF CUSTOMERS ICON

Regulatory Compliance Experts

 

Deep expertise in GMP, GxP, FDA, EMA, and MHRA requirements.

REPHINE PURPLE ACCENT QMS DEVELOPMENT ICON

Tailored Validation Solutions

 

Customised approaches for pharmaceutical, biotech, and medical devices sectors.

REPHINE PURPLE ACCENT SYS PROCESSES ICON

Advanced Technology Integration

 

Leveraging automation & AI to improve validation efficiency.

REPHINE PURPLE ACCENT POST SUBM LIFECYCLE ICON

End-to-End Support

 

From initial risk assessments to post-implementation monitoring.

Meet the Validation Experts

Sandra Lacruz CSV Consulting Line Director Headshot

Sandra lacruz

CSV Consulting Services Line Director

REPHINE SPEECH MARKS OPEN DIGITALISATION

A compliant SAP S/4HANA upgrade is key to data integrity and operational continuity.

REPHINE SPEECH MARKS CLOSE DIGITALISATION

Secure Your SAP S/4HANA Compliance Today!

Ensure a risk-free, GMP-compliant SAP upgrade with expert validation from Rephine.

Using touchpad

Looking for more digital based QA solutions?

Our Digitalisation experts can provide ongoing assistance with customisable CSV systems, regulatory consultancy, and more, to help with your QA journey.

Discover our other Digitalisation services and how are experts can help you.

Related Resources

Ensuring Compliance and Data Integrity in Pharmacovigilan CAPA

Strengthening CAPA & Exceptions Management

Learn how Rephine’s tailored GxP training helped a pharmaceutical manufacturer strengthen CAPA effectiveness, improve compliance, and boost team confidence.
Read More
GMP Raising the bar Blog series Header image May 25 Blog

EU GMP Annex 1 vs FDA Aseptic Guide: Bridging Compliance

EU and U.S. regulators share the same sterility assurance goals, but their approaches differ. Learn how to align Annex 1 and FDA guidance to streamline ...
Read More
GMP Raising the bar Blog series Header image May 25 Blog

GMP & GDP: Ensuring Quality in Drug Storage and Transport

Storage and transport aren’t just logistics — they’re critical GMP processes. Discover how USP helps pharma companies manage risk and maintain quality across global ...
Read More
GMP Raising the bar Blog series Header image May 25 Blog

Blockchain for GMP Documentation: Hype or Future Reality?

Blockchain promises immutability, traceability, and transparency for GMP documentation. But is it a compliance game-changer — or just hype?
Read More
CSV Blog

Data Governance & AI in Pharma | Ensuring Trust & Compliance

In an age where AI promises transformation across pharma, success hinges on one factor: data you can trust. Explore how rigorous governance, quality control, and ...
Read More
Ensuring Compliance and Data Integrity in Pharmacovigilan Case Study

Global Audit Management for Pharma Company

Discover how Rephine helped a global pharmaceutical company streamline supplier audits, reduce internal workload, and strengthen compliance assurance.
Read More
Ensuring Compliance and Data Integrity in Pharmacovigilan Case Study

GMP Compliance for Global Cosmetics Manufacturer

This case study shows how Rephine helped a global cosmetics manufacturer achieve GMP compliance, FDA readiness, and OTC production capability.
Read More
GMP Raising the bar Blog series Header image May 25 Blog

AI in CAPA & Deviation Management: Balancing Compliance

AI is reshaping CAPA and deviation management. This blog explains how to harness efficiency gains while ensuring compliance with Annex 22, Annex 11, and QRM.
Read More
GMP Raising the bar Blog series Header image May 25 Blog

NLP in Pharma Audits: Unlocking Compliance Insights

Audit data is vast but underused. This blog explores how NLP can mine audit reports, reveal compliance trends, and strengthen regulatory intelligence.
Read More

Where do you Need our Help?

For GMP Auditing, Quality Assurance & Digitalisation, we’re the partner of choice for all the stakeholders we deal with.

We provide extensive GMP consulting services to help keep our clients ahead of the needs and expectations of regulators.

REPHINE AUDIT GREEN GAP ANALYSIS ICON

Global Audit Library

Explore our extensive GMP audit library to see the range and scope of live reports we have in stock, join a live audit, or commission a bespoke audit

REPHINE AUDIT GREEN AUDIT REPORT LIBRARY ICON

GMP Audit Services

Maintain high standards of life sciences manufacturing supplier qualifications and GMP auditing within the supply chain through our expertise

REPHINE AUDIT BLUE INOVATION CONVOS ICON

GxP Consultancy

Discover how we can help your product reach to market, fully and demonstrably complying with the latest GxP standards

REPHINE DIGITALISATION PURP POST SUBM LIFECYCLE ICON

Digitalisation

From data integrity to implementing new systems, our experienced team with a digital mindset, can lead you to transformative achievements

Let's get in touch

Please get in touch. Our expert GMP audit team is only a click away, on standby to answer all your questions.
Social: Linkedin

REPHINE HQ

REPHINE BARCELONA S.L.U

  • Barcelona, Spain                               
  • +34 934 178065

REPHINE CHINA

  • Shanghai, China 

REPHINE INDIA

  • Hyderabad, India                               

Contact Us

Strengthen Your Assurance Journey

GMP Chapter 22 Adapting to Hybrid Documentation Standards