Data Integrity Consulting
Reliable data is the foundation for compliant digital transformation in pharma. Körber helps organizations strengthen data integrity across systems, processes, governance, and decision-making.
Identify weaknesses, reduce risks, and safeguard your data.
In numbers
+10
Körber works with the Top 10 global pharma companies and smaller businesses, so you benefit from experience across different types of operations.
50%
Around 50% of FDA warning letters are about data integrity issues, highlighting the need for better compliance frameworks.
Benefits
Reduced regulatory risks
Be prepared for inspections with a maturity assessment that helps identify gaps, map risks, and define clear mitigation actions.
Fully compliant with global requirements
Align data governance with key global regulators including FDA, EMA, MHRA WHO, and PIC/S to meet global data integrity requirements.
Expert guidance
We prepare organizations for upcoming inspections with actionable plans aligned with GAMP® 5 and ALCOA+ methodologies.
Improve across all data layers
Strengthen data integrity across systems, processes, people, and governance with a unified, risk-based approach that supports reliable digital operations.
A structured approach to compliant and reliable data
Körber’s Data Integrity services provide a structured framework to assess, improve, and sustain data quality across pharmaceutical operations. By using our Data Integrity Maturity Assessment, organizations gain a clear understanding of gaps, risks, and current performance levels.
Our approach aligns with ALCOA+ principles and global regulatory expectations, while also addressing the realities of increasingly digital and connected pharma environments. It integrates systems such as MES, LIMS, QMS, and digital documentation platforms to create reliable, traceable, and audit-ready data flows.
By combining regulatory expertise with practical implementation, Körber helps organizations standardize data handling, reduce manual errors, and strengthen governance. This results in improved audit outcomes, reduced compliance risks, and long-term reliability of critical data used for decision-making.
End-to-end ecosystem
A partner you can trust throughout the entire lifecycle
Körber operates across the full GMP digital ecosystem. Instead of thinking in isolated systems, our approach connects data flows across technologies, processes, and organizational structures to create a unified, risk-based framework for governance and compliance.
Our ecosystem spans across:
- Core systems such as MES, LIMS, QMS, DMS, and ERP
- Equipment and automation systems that generate raw data
- Validation lifecycle frameworks from user requirements specification (URS) to performance qualification (PQ)
- Digital transformation and Pharma 4.0 initiatives
- Quality management, risk assessment, and governance processes
By integrating these elements, we help your organization reduce fragmentation and silos, improve transparency, and ensure that the data used for decision-making, regulatory submissions, and audits meets all global compliance demands.
Explore more about Data Integrity & Compliance in Pharma
Case studies
Learn how our solutions work in the real world.
Our solutions
From assessment to implementation, Körber helps pharma companies strengthen data integrity across systems, processes, governance, and operations, creating the reliable foundation needed for compliant digital transformation.
Software implementation
Fast, expert SAP EWM and WMS rollout with Körber’s software implementation services: process-first guidance, low complexity and seamless integration.
Validation
We provide expert consulting services to support the validation and qualification of your equipment, software, and processes according to regulatory standards.
Machine qualification
Keep patients safe and production on track with reliable, compliant machine qualification across the full lifecycle.
