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CaliberBRM

100% paperless batch record manufacturing and production control for regulated pharma and life sciences manufacturing.

Solution by Caliber
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Overview

CaliberBRM (Batch Record Manufacturing) is a digital manufacturing solution developed by Caliber, designed specifically for pharmaceutical and other regulated industries seeking to eliminate paper-based processes on the shopfloor. By digitalizing batch production records and providing end-to-end control over man, machinery, methods, and materials, CaliberBRM enables organizations to standardize operations, accelerate review processes, and achieve compliant, fault-free manufacturing at scale.

Caliber's broader manufacturing suite goes far beyond simple electronic batch records, offering a comprehensive platform that drives quality processes, enhances precision, and ensures uncompromised regulatory compliance. With review-by-exception and right-first-time approaches built into the solution, businesses gain a competitive edge while remaining consistently audit-ready and confident in the safety of their products.

Core Modules and Capabilities

  • CaliberBRM – Batch Record Manufacturing: Digitalizes batch production records and delivers complete control over all manufacturing inputs. Standardizes operations and accelerates review cycles to support compliant, fault-free production.
  • CalibereLog – Electronic Logbooks: Enhances the routine process of maintaining equipment logs, ensuring thorough compliance with stringent statutory regulations and keeping facilities perpetually audit-ready.
  • CaliberIPQC – In-Process Quality Checks: Assesses product quality while batch manufacturing is still in progress. Functioning as an independent module of CaliberBRM, it streamlines quality assessment and ensures adherence to specifications in real time.
  • Punches and Dies Management: Provides exclusive identification, management, and tracking of punches and dies at a facility, ensuring adequate inventory levels, proper maintenance, and enhanced production efficiency.

Key Benefits and Approach

  • Enables 100% paperless manufacturing by completely eliminating manual efforts across the production process.
  • Promotes faster time-to-market through streamlined, digitalized workflows and reduced administrative overhead.
  • Supports regulatory compliance and audit readiness through review-by-exception and right-first-time methodologies.
  • Delivers a scalable, reliable, and highly focused digital platform designed to grow with manufacturing operations.
  • Enhances shopfloor efficiency and productivity while maintaining uncompromised product quality and safety.

Platform and Scalability

  • Caliber's manufacturing suite is built to be robust, extensive, and competitive, supporting the full spectrum of digital manufacturing maturity.
  • Solutions are designed to be easily leveraged across facilities, with a focus on scalability and reliability for regulated environments.
  • The platform is continuously innovated to address the evolving needs of pharmaceutical and regulated industry manufacturers.

CaliberBRM and the wider Caliber manufacturing suite are purpose-built for regulated industries where compliance, quality, and operational efficiency are non-negotiable. The solution's end-to-end digital approach makes it well suited for organizations looking to assess and advance their shopfloor digital maturity while confidently meeting audit and regulatory requirements.

Meta

Software type(s)
Workflow Automation
Deployment type(s)
Cloud / SaaS
Industry vertical(s)
PharmaBiotech
Development stage(s)
Manufacturing
Target user(s)
Lab Manager / Core Facility ManagerQA / Regulatory AffairsAutomation Engineer
Compliance standard(s)
21 CFR Part 11GxP