ERP for Life Sciences & Biotech. Built for Compliance & Growth

Cegeka ERP solutions for Biotechnology & Life Sciences embed compliance directly into operations through:

• Electronic signatures (21 CFR Part 11 compliant)
• Audit trails for all transactions
• Controlled documentation and versioning
• Automated quality and approval workflows

This helps companies maintain continuous compliance and stay audit-ready at all times.

Batch traceability allows companies to track every material, ingredient, and process step throughout production.
In biotech and pharma, this is essential to:

• Ensure patient safety
• Manage product recalls
• Pass regulatory audits
• Maintain full genealogy from raw material to finished product

A modern ERP provides end-to-end visibility across the entire supply chain.

ERP systems designed for life sciences follow structured validation methodologies (e.g., GAMP 5), ensuring that systems are validated and documented from day one.
This enables:

• Faster validation processes
• Reduced compliance risk
• Always up-to-date audit documentation
• Continuous inspection readiness

As biotech companies grow, they must transition from flexible R&D environments to highly controlled manufacturing processes.
ERP supports this shift by:

• Standardizing processes
• Automating quality management
• Enabling production planning and control
• Ensuring compliance at scale

This allows companies to grow without increasing operational complexity and reduce costs.

Microsoft Dynamics 365 provides a flexible, cloud-based ERP platform that can be tailored for life sciences requirements.
Together with Cegeka’s industry solution, it enables:

• Real-time data across all operations
• Scalable cloud infrastructure
• Integration with data and AI platforms
• Secure, compliant environments

Cegeka combines Microsoft Dynamics 365 with a validated life sciences framework, offering:

• Pre-configured GxP-compliant processes
• Faster implementation with lower risk
• Industry-specific data models
• Proven methodology (validated by partners like Epista)

This ensures faster time-to-value while maintaining full regulatory compliance.

Yes. ERP systems enhance quality and manufacturing by:

• Integrating quality management into production
• Automating batch control and deviations
• Ensuring adherence to GMP standards
• Providing real-time insights into production performance

This leads to consistent product quality and reduced compliance risk.

Modern cloud ERP solutions meet strict security and regulatory standards, offering:

• Data encryption and access control
• Validated environments
• Continuous updates and compliance support
• High availability and disaster recovery

This makes cloud ERP a strong foundation for compliant and scalable biotech operations.