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elogbook: Harmonized logbooks

Manually-entered logbooks consume significant time and effort, and still remain error-prone, not to mention the risk of GMP non-compliance. Generating, reviewing and approving logs, and then the need to retrieve the information, often stored in different physical locations, during audits and inspections, entail a digital solution necessarily.

BUSINESS NEED

FDA 483

High probability of human errors

Reduced Productivity

No Insights

Our APPROACH

  • Harmonization: Setting up CoE within plants to harmonize logs which can be deployed horizontally
  • Data Standardization: Master data for equipment, activities standardized for digital analytics enablement
  • Deployment of Logs: Configuration and Development of logbooks with controls to enforce compliance
  • Data Analytical models to provide details on golden time and micro breakdowns
  • Data Integration with SAP or other business systems for keeping single point of truth

Our RESULTS

21 CFR Part 11 Compliance

21 CFR Part 11 Compliance

Data integrity – enforce legible & dependable data

Data integrity – enforce legible & dependable data

Digital Compliance

Digital Compliance

Accurate reproduction of data

Accurate reproduction of data

Standardization – GDP Practice

Standardization – GDP Practice

Granular data for OEE improvement

Granular data for OEE improvement

Insights on capacity release

Insights on capacity release

Centralized data repository to enable objective decisions for better productivity and performance of plant

Centralized data repository to enable objective decisions for better productivity and performance of plant

Case STUDY

A Case Study on Digital Logbook

In today's complex industrial landscape, efficient control and management of processes and data are paramount. This case study examines the successful implementation of a digital logbook in a manufacturing facility, showcasing how this technology revolutionized operations and decision-making.

Case STUDY

A Case Study on OEE

Discover how our OEE solution transformed pharmaceutical operations, boosting efficiency and driving measurable business impact.

Elevate your business with technology

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