EBR

Vimachem's Electronic Batch Records (EBR) software is a cloud-based, pre-validated solution designed for pharmaceutical and biopharmaceutical manufacturers. It digitizes batch record management to enhance quality, production efficiency, and regulatory compliance — replacing paper-based processes with automated, real-time data capture and streamlined workflows. The platform is purpose-built for manufacturing, quality, and compliance teams facing pressure to ensure batch integrity, reduce manual effort, and accelerate product release.

Vimachem's EBR addresses core industry challenges through automation, standardization, and real-time visibility. By eliminating manual data entry and surfacing only critical deviations for review, it enables quality teams to focus their expertise where it matters most — cutting review time, reducing errors, and supporting right-first-time batch execution across single and multi-site operations.

Key Benefits

• Faster, smarter batch reviews: A review-by-exception approach flags only deviations and critical issues, allowing QA teams to accelerate approvals while maintaining compliance and product integrity — with one VP of Quality Operations reporting a 50% reduction in review time.
• Pre-validated for rapid deployment: The solution ships with a comprehensive, out-of-the-box IQ/OQ validation package, reducing deployment timelines by at least two months and ensuring full compliance from initial rollout.
• Seamless system integration: Built to integrate effortlessly with existing ERP, MES, QMS, LIMS, and lab systems, minimizing setup time and enabling a smooth transition without additional infrastructure investment.

Core Software Capabilities

• Automated data capture and real-time visibility: Eliminates manual data entry through automated, real-time tracking of production activities, enhancing accuracy and enabling data-driven decisions across operations.
• Faster, right-first-time batch reviews: Automated checks and exception handling minimize rework, improve compliance, and speed up batch release.
• Configurable workflows and role-based access: Workflows, approvals, and user permissions can be tailored to specific processes, ensuring regulatory compliance while improving operational agility.
• Advanced reporting and operational dashboards: Built-in dashboards visualize production trends and support continuous improvement, faster audits, and informed decision-making.
• Scalable recipe and process management: A flexible, low-maintenance recipe framework adapts easily to new products, regulatory updates, or process changes.
• Mobile-friendly and device agnostic: Production data can be accessed and managed securely from any device, enabling real-time collaboration across teams and manufacturing sites.
• IoT and smart sensor integration: Seamless connectivity with IoT devices and smart sensors improves data accuracy and enables real-time monitoring.

GxP Compliance and Data Integrity Features

• User-level permissions and security: Role-based permissions with Active Directory integration enable secure login, password policies, and simplified user administration with reduced IT overhead.
• Verified data integrity: Built-in input validations, audit trails, and role-based access restrictions support data integrity at every stage of production.
• Electronic records and signatures: Fully compliant with FDA 21 CFR Part 11 and EU GMP Annex 11, ensuring secure, traceable, and auditable records with verified electronic signatures.
• Complete digital records: Captures a full digital history of all shop floor activities, including device usage, material handling, and equipment logs.
• Configurable electronic signatures: Electronic signatures are embedded in workflow steps to ensure compliance and consistency across all production stages.
• Flexible data exports: Data can be exported in XLSX and XML formats, manually or automatically, simplifying reporting, analysis, and system integrations.

Modular Add-Ons for Extended Capability

• Weigh and Dispense Module: Integrates material handling capabilities to automate weighing processes, reduce human error, and maintain full traceability from raw material to final batch.
• Manufacturing Analytics and OEE: Provides real-time performance insights to optimize efficiency and resource utilization across manufacturing operations.

Vimachem's EBR is part of the broader Vimachem Pharma MES Platform and is designed to scale across multi-site, global manufacturing environments. The solution complies with FDA 21 CFR Part 11, EU GMP Annex 11, and GMP standards, and its pre-validated status with a complete IQ/OQ package ensures regulatory readiness from day one. Computerized System Validation (CSV) services are also available to support ongoing compliance throughout the system lifecycle.