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Validation sevices

Ensuring compliance with a cloud based Lite MES and EBR solution requires well-defined controls and processes, shared between MS Azure, BatchLine, and our customers.

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Qualified infrastructure

Our Azure infrastructure is qualified to demonstrate proper configuration, maintaining a state of control and compliance.

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GAMP 5 Classification

Batchline adopts a risk-based qualification and validation approach in line with GAMP 5 2nd Edition and CSA guidance, classifying our EBR application as Category 4 (configurable software).

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Validation lifecycle

Robust security models and quality practices are maintained throughout the lifecycle phases, with options for customers to perform functional tests or operational qualification (OQ) based on predefined acceptance criteria.

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Navigate the assurance journey with our Validation Services, where each phase is tailored to ensure compliance and system reliability.

Planning, Risk Assessment, and Specification

In the initial phase, we collaboratively plan and conduct a thorough risk assessment to identify potential challenges. This stage lays the foundation for precise specifications, outlining the criteria for successful validation.

Verification & Report

Moving forward, our validation experts execute rigorous verification processes, validating that Batchline Application aligns with the specified requirements. The comprehensive report generated at this stage provides a transparent overview of the validation outcomes, ensuring clarity and accountability.

SOP, Batchline Application Qualification Report

As we progress to the final phase, we supply Standard Operating Procedures (SOPs) and craft a detailed Batchline Application Qualification Report. This report serves as a comprehensive guide, offering insights into the validation journey, system performance, and adherence to industry standards.

At every step, our Validation Services prioritize precision and transparency, ensuring your system meets regulatory expectations, providing you with confidence in the reliability and compliance of your Batchline Application.

Ready to get started?

Discuss your business requirement with one of our consultants and arrange a demo

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