ACE EBR

ACE EBR is an electronic batch record management solution developed by PSC Software, designed for manufacturing and life sciences teams working with pharmaceuticals, biologics, and medical devices. It replaces manual, paper-based batch records with a fully digital system that centralizes batch planning, execution, review, and documentation on a single platform.

The system is built to support regulatory compliance with FDA and EU GMP standards, including 21 CFR Part 11 requirements, and scales from single-site facilities to global manufacturing operations.

Core Batch Management Capabilities

• Provides a unified platform to plan, track, review, and manage batches from start to finish.
• Centralizes batch data with real-time visibility and traceability across manufacturing operations.
• Monitors batch execution progress and manages corresponding documentation in one secure location.
• Automates data entry to reduce manual input and associated errors.
• Enforces process consistency through system-driven workflows that ensure operators follow standard operating procedures.

Process Enforcement and Quality Controls

• Supports custom conditions on fields within batch plans to verify that operator-entered data falls within acceptable tolerance ranges.
• Allows flags to be set that stop batch execution or a specific batch step, or that warn operators and reviewers when conditions are not met.
• Logs, tracks, and resolves deviations and exceptions directly within the batch workflow.
• Automatically generates compliant batch records meeting FDA and EU GMP standards.
• Includes built-in 21 CFR Part 11 compliant electronic signatures for full traceability.

Review and Audit Readiness

• Streamlines batch record review processes to support production timelines and faster product release.
• Supports review by exception, allowing teams to focus attention on flagged or out-of-tolerance entries.
• Provides centralized access to records to simplify audit preparation and execution.
• Maintains automated audit trails throughout the batch lifecycle.

Operational Benefits

• Reduces human error through automation of data entry and process enforcement.
• Improves visibility and control across manufacturing operations with real-time batch performance insights.
• Supports continuous improvement and process optimization through data captured during batch execution.
• Scales with team size and quality requirements, from individual facilities to multi-site global operations.

ACE EBR integrates with other modules within the ACE platform, including quality management and equipment management, allowing batch record data to connect with broader operational workflows within the same software ecosystem.