xLM Validates Sage X3 ERP & Toolbox Apps for SCA Pharma
SCA Pharma, a trusted leader in pharmaceutical manufacturing, needed to validate its Sage X3 ERP system and Toolbox applications across multiple facilities. With strict cGMP compliance requirements and a complex multi-system environment, SCA Pharma turned to xLM to ensure audit-ready validation and seamless system integration.
When Validating Critical Systems, Precision Can't Be Compromised.
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The Challenge
SCA Pharma faced several hurdles:
- Regulatory Pressure: Compliance with stringent cGMP standards required precise, audit-ready documentation.
- Complex System Landscape: Multiple facilities and interconnected systems increased validation complexity.
- Efficiency Demands: Manual processes were slowing down operations and increasing risk.
A structured, risk-based validation strategy was crucial to meet both regulatory and operational requirements.
The Solution
xLM implemented a comprehensive three-phase methodology with end-to-end tracing to deliver seamless validation.
Key actions included:
- Validated Sage X3 ERP and 79 applications with precision and consistency.
- Delivered complete documentation: URS, FRS, automated executed test scripts, traceability matrices, and risk/change controls.
- Fostered collaboration between IT and business teams to align on compliance, risk management, and process improvements.
- Provided scalable validation practices to future-proof SCA Pharma’s systems.
The Result
By partnering with xLM, SCA Pharma achieved:
- Audit-ready validation across ERP and Toolbox applications system.
- Enhanced compliance with cGMP standards.
- Streamlined change control and risk management processes.
- Stronger alignment between business processes and system functionality.
"xLM teams' depth of expertise in IT GxP Compliance and their unique toolsets that automate and accelerate validation have been game-changers for us. Their procedures have made SCA’s GxP compliance more efficient and effective." – Thena Alagappan, Head of IT, SCA Pharmaceuticals.
Services Provided
- Sage X3 ERP Validation
- Custom Toolbox Applications Validation
- Continuous Validation
- Regulatory Compliance