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CaliberIPQC

Automated in-process quality control for pharmaceutical manufacturing, with test protocols, sample scheduling, equipment calibration, and batch reporting.

Solution by Caliber
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Overview

CaliberIPQC is a digital in-process quality control software solution designed specifically for pharmaceutical manufacturers. It replaces traditional, manual quality control methods with a seamlessly integrated, automated ecosystem that ensures precision, compliance, and efficiency at every stage of the production process. By providing concise test reports for each batch, CaliberIPQC empowers drug manufacturers to reduce effort, time, cost, and administrative clutter while delivering high-quality products to market faster.

Pharmaceutical companies of all sizes can leverage CaliberIPQC to revolutionize their quality assurance operations — from automating testing workflows and scheduling sample withdrawals to managing equipment calibration and generating comprehensive batch reports. The platform is built to meet the rigorous demands of pharma manufacturing while offering the flexibility to adapt to individual client requirements.

Test Protocol and Pattern Management

  • Includes a comprehensive test protocol with predefined test patterns, acceptance criteria, limits, and groups.
  • Supports both quantitative tests such as weight and hardness, and qualitative tests such as visibility checks.
  • Automatically defines sample patterns based on initial instructions, eliminating duplication of tasks and ensuring consistency across testing procedures.

Sample Withdrawal Scheduling

  • Schedules sample withdrawals automatically based on predefined configurations, including frequency, department, and applicable test protocols.
  • Offers a flexible scheduling system that can be customized to meet specific client requirements.
  • Ensures timely and accurate sample testing throughout the production lifecycle.

Equipment Calibration Management

  • Automatically generates and triggers calibration schedules based on set frequencies to maintain equipment accuracy and regulatory compliance.
  • Sends alerts for unscheduled calibrations in the event of equipment failure or maintenance needs, facilitating prompt action and issue resolution.

Problem and Service Reporting

  • Alerts users to technical issues and service requirements as they arise during operational transactions.
  • Notifies relevant parties in real time and updates equipment status to support effective and timely problem resolution.
  • Minimizes production downtime by ensuring issues are flagged and addressed promptly.

Reporting and Yield Reconciliation

  • Offers a wide range of configurable reports including yield reports, batch protocol reports, and stage closure reports.
  • Allows users to customize report layouts and field placements to enhance usability and operational efficiency.
  • Provides configurable yield ranges and limits tailored to the specific requirements of drug manufacturers.
  • Delivers comprehensive yield reports with insights into batch performance at every stage of production.

CaliberIPQC is purpose-built for the pharmaceutical manufacturing environment, combining automation, flexible configuration, and real-time alerting to streamline quality assurance processes, improve operational efficiency, and support ongoing regulatory compliance across all production stages.

Meta

Domain
Manufacturing & Bioprocessing
Subdomain
Batch Records & In-Process Quality Control
Software type(s)
Workflow Automation
Deployment type(s)
Cloud / SaaS
Industry vertical(s)
PharmaBiotech
Development stage(s)
Manufacturing
Target user(s)
Bench Scientist / Lab TechnicianLab Manager / Core Facility ManagerQA / Regulatory Affairs
Compliance standard(s)
21 CFR Part 11GxP