Back To Case StudiesData Quality and Compliance Automation for a Global Pharmaceutical Enterprise
Introduction
Pharmaceutical organizations operate in a highly regulated environment where data integrity, compliance, and accuracy are vital to ensuring product safety and regulatory approval. Fragmented data systems, manual validation, and outdated reporting processes often create compliance risks and operational inefficiencies.
A global pharmaceutical enterprise partnered with Axia Kairos to establish a unified data governance, testing, and compliance automation framework. The engagement was centered on SAP Datasphere and SAP BTP, aimed at improving data transparency, accelerating quality checks, and ensuring adherence to global regulatory standards such as FDA, EMA, and ISO.
Business Challenge
The enterprise faced difficulties maintaining consistent data quality across R&D, manufacturing, and distribution systems. Manual validation and compliance reporting slowed operations and increased the risk of regulatory deviations.
Key challenges included:
Inconsistent data across ERP, LIMS, and quality control systems.
Manual compliance checks delaying batch release and audit readiness.
Disconnected reporting processes impacting regulatory submissions.
Absence of automated testing frameworks for validation of critical systems.
Need for data lineage and traceability for audit and certification compliance.
Solution Implemented
Axia Kairos designed and deployed a Data Quality and Compliance Automation Framework leveraging SAP Datasphere, SAP BTP, and automated testing solutions. The initiative focused on enabling a unified view of product, process, and compliance data across the enterprise.
SAP Datasphere Implementation
Consolidated R&D, production, and quality data for real-time traceability and compliance monitoring.
Compliance Automation
Automated validation workflows for product release, deviation tracking, and document management.
Testing Automation
Established automated regression and validation scripts to verify system performance, reducing QA time by over 40%.
SAP BTP Integration
Connected enterprise data sources under a secure and scalable governance model for audit transparency.
Reporting & Dashboards
Built compliance dashboards to monitor KPIs for quality assurance, regulatory status, and batch certification.
Audit Readiness
Enabled automated evidence generation for internal and external audits.
Technologies & Services Used
SAP Datasphere
SAP BTP (Business Technology Platform)
Testing Automation
Compliance Automation
Data Governance Frameworks
Results & Impact
The pharmaceutical organization achieved a unified, compliant, and automated operational environment, significantly reducing manual intervention and audit risks.
Faster Validation & Compliance Cycles
Achieved a 45% acceleration in validation cycles through automated testing workflows, digital approvals, and streamlined compliance processes across quality functions.
High-Accuracy Data Across Systems
Delivered 99% data accuracy across production, quality, and regulatory systems by implementing integrated data flows, automated checks, and standardized reporting.
Improved Audit Readiness
Strengthened audit preparedness with complete digital traceability across product lifecycles, enabling faster evidence retrieval and higher compliance confidence.
Reduced Non-Compliance Incidents
Lowered non-compliance risks by implementing standardized governance frameworks, automated validations, and proactive quality checks.
Faster Regulatory Submissions
Improved regulatory submission and approval timelines through structured documentation, automated data consolidation, and unified compliance workflows.
Enhanced Enterprise Quality Management
Created an intelligent, compliant quality ecosystem that improves efficiency, transparency, and long-term regulatory resilience for the enterprise.