YAVEON ProBatch

YAVEON ProBatch for Pharma & Medtech

Easy system validation and compliance in the process industry

We understand the challenges in pharma and medtech

Constant Innovation

In a global economy where new players continuously enter the market, companies face increasing pressure to launch groundbreaking products. Our ERP solution streamlines R&D processes through automated data management, enabling faster innovation and reducing time-to-market.

Cost Pressure

Global demand for medicine is rising while budgets shrink. The pharmaceutical industry faces high research expenditures and production costs. Our ERP solution optimizes financial forecasting, procurement, and resource allocation, helping you stay cost-effective through data-driven decision-making.

Laws and Regulations

Compliance demands are growing more complex, with GxP, FDA, MDR, and UDI requirements shaping daily operations. Our ERP solution ensures compliance through built-in regulatory monitoring, automated reporting, and comprehensive audit trails.

Validation

NORRIQ has successfully delivered ERP projects where logistics and financial processes were separated from validation obligations, ensuring efficient operations without added regulatory burdens. For businesses requiring full ERP system validation, we provide a compliant, validated solution.

Quality Standards

As quality requirements, controls, and safety measures tighten, companies must also manage supplier assessments and regulatory compliance. Our ERP solution for pharma companies includes integrated Quality Management Systems (QMS) and supplier management features for continuous and reliable quality inspections.

Resource Scarcity

Limited access to raw materials and supply chain disruptions challenge continuous production. Our ERP solution for pharma process production supports seamless planning with real-time inventory tracking, demand forecasting, and supplier collaboration, ensuring uninterrupted production.

Get YAVEON ProBatch

Pharma Medtech

Ready for GAMP 5

The YAVEON ProBatch solution is developed according to GAMP 5 specifications, ensuring compliance with the requirements for implementing a validated ERP system.

Meeting computer system validation standards requires adherence to GAMP 5 guidelines. NORRIQ's YAVEON solution for the pharma/medico industry is designed to meet these strict requirements, including specifications for critical GxP processes.

Key Features:

  • Comprehensive product documentation and validation process templates
  • Support for change management and system updates
  • Customization to match specific validation requirements
  • Compliance with GMP standards through relevant documentation
  • Developed according to GAMP 5, ensuring readiness for validated ERP system implementation

Regulatory Compliance

GMP Part 4 Annex 11, FDA 21 CFR 11, 21 CFR 210/211?

Regulatory compliance can be time-consuming and complex. NORRIQ's YAVEON solution streamlines these processes, helping businesses meet MDR and FDA standards efficiently.

YAVEON also supports cloud-based validation. Certified pharma/medico companies using Business Central with ProBatch in the cloud benefit from a validated solution with monthly updates.

Thanks to YAVEON's meticulous preparation, this process requires minimal effort, ensuring seamless compliance with regulatory standards.

ProBatch
May Britt Dyvelkov VP Finance Manager
We got more for the money than we had expected. It’s great to achieve such a good collaboration with an external partner. I would definitely recommend NORRIQ

May Britt DyvelkovVP Finance Manager

ViroGates

See YAVEON ProBatch in action

vimeo
vimeo
vimeo
vimeo