ACE EBR™

Seamless, Compliant, and Fully Digital Batch Records

End-to-end batch management while improving efficiency

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Enhanced Batch Oversight

Track and manage batch records with real-time data, improving decision-making and ensuring timely delivery.

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Accelerate Review

Streamline batch record review processes to meet production timelines and bring products to market faster.

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Increase Compliance

Ensure regulatory readiness with automated documentation and audit trails.

Here’s How ACE EBR™ can
transform your batch record management

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Centralized Batch Management

One Platform for All Your Manufacturing Needs

ACE EBR™ provides a unified system to plan, track, review, and manage batches from start to finish. centralizes batch data, providing real-time visibility and traceability, monitor batch execution progress, and manages corresponding documentation on a single, secure platform. Improve efficiency, reduce errors, and gain real-time insights into batch performance.

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Traceability

Streamline Production with Confidence

ACE EBR™ provides a modern solution to batch record management by automating data entry, enforcing process consistency, and offering real-time visibility into manufacturing operations. Whether you produce pharmaceuticals, biologics, or medical devices, ACE EBR™ helps ensure every batch meets quality and compliance standards. From single-site facilities to global operations, ACE scales with your team and your quality needs.

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Process Enforcement

Ensure operators follow SOPs through system-driven workflows. Add custom conditions to fields in your batch plan ensuring that data entered by operators is within acceptable tolerance ranges. Set flags to stop the batch execution, batch step, or warn reviewers and operators if conditions are not met.

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Audit-Ready Batch Records

Automatically generate compliant records that meet FDA and EU GMP standards.

Built-in 21 CFR Part 11 compliant e-signatures for full traceability.

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Deviation & Exception Handling

Log, track, and resolve exceptions within the batch workflow.

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Seamless Integration

Fully connects with all of ACE. Seamless integration with ACE’s quality and equipment management.

Why It Matters

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Reduce human error and manual entry

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Accelerate batch release and review by exception

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Simplify audits with centralized access to records

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Improve visibility and control across operations

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Drive continuous improvement and process optimization

Talk to an expert

Get answers to your questions and discover how ACE can help you transform your business with modern validation management.