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.

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?

Regulatory Compliance Experts

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

Tailored Validation Solutions

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

Advanced Technology Integration

Leveraging automation & AI to improve validation efficiency.

End-to-End Support

From initial risk assessments to post-implementation monitoring.

Meet the Validation Experts

Sandra lacruz

CSV Consulting Services Line Director

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

Secure Your SAP S/4HANA Compliance Today!

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

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.

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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

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?

Change Assessment

Risk Assessment

Test plan

What Sets Rephine Apart?

Regulatory Compliance Experts

Tailored Validation Solutions

Advanced Technology Integration

End-to-End Support

Meet the Validation Experts

Sandra lacruz

CSV Consulting Services Line Director

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

Secure Your SAP S/4HANA Compliance Today!

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

Looking for more digital based QA solutions?

Related Resources

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.

Global Audit Library

GMP Audit Services

GxP Consultancy

Digitalisation

Let's get in touch