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CaliberBRM

Electronic batch record software for compliant, paperless pharmaceutical manufacturing, ensuring error-free batch releases and enhanced data integrity.

Solution by Caliber
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Overview

CaliberBRM is an advanced electronic batch record management software designed to transform pharmaceutical manufacturing processes by eliminating paper errors, recalls, and warnings. It ensures compliant, digital batch manufacturing for safe market release.

This software facilitates a seamless transition to digital manufacturing with traceable, easy-to-understand batch records, automated logbooks, and consistent in-process quality checks. Its lightweight architecture is both flexible and scalable, extending beyond traditional manufacturing execution systems (MES) capabilities.

CaliberBRM exemplifies manufacturing excellence by automating logbooks, ensuring error-free batch releases, and enabling 100% paperless operations. It offers configurable templates, flexible workflows, and seamless integrations for a strategic shift to digital processes.

The software accelerates batch releases by providing timely alerts for discrepancies, thereby consistently eliminating errors. It supports scalable, compliant manufacturing operations.

Key Features

  • Automated batch records for enhanced quality management and data integrity.
  • Reliable, traceable, and easily retrievable electronic batch records.
  • Electronic log management to reduce human errors and compliance issues.
  • Automated in-process quality checks to maintain product quality and compliance.
  • Punches and Dies module for inventory management and lifecycle monitoring.

CaliberBRM also includes modules like CaliberIPQC for in-process quality control and CalibereLog for electronic log management, ensuring real-time data capture and audit readiness.

A customer success story highlights how Zydus, a global pharmaceutical manufacturer, overcame challenges in sample analysis and quality checks by digitalizing with CaliberIPQC, leading to reduced task duplication and improved quality standards.

Overall, CaliberBRM offers a comprehensive 360° framework for managing batch manufacturing processes, ensuring that records are retrievable, trackable, and error-free, while enabling paper-free, 21 CFR Part 11-compliant manufacturing.

Meta

Category
Bioprocess Development & Manufacturing
Field(s)
Manufacturing & BioprocessingQuality & Compliance
Target user(s)
QA / Regulatory Affairs
Tag(s)
Bioprocess / ManufacturingQuality & Compliance Management