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The Evolution of Electronic Systems in the Pharmaceutical, Biotech & Medical Devices Industry

Blog Home | Published: February 6, 2017

Electronic systems were introduced in the industry over 35 years ago. Early in the lifecycle, electronic systems enabled companies to partially automate document management, change control, data acquisition and deviation processes. Unfortunately, these systems were unable to fully automate the quality systems processes and eliminate the need to use paper documents. The inability of eliminating paper based process created a significant amount of inefficiencies, risk associated to data integrity and compliance with document record retention requirements.

In the last 15-20 years the technology has evolved into full automation of quality system processes including validation and enabled eliminating inefficient paper based processes.

Over the last 20 years the technology has matured and evolved in providing electronic systems to fully automate the following processes

  • Validation Lifecycle Management integrated with change control
  • Change Control
  • Deviations and CAPA
  • Document Management

Early in the lifecycle of electronic systems for deviations, CAPA and change control the industry was very apprehensive and slow from moving away from paper. Over the last 20 years the industry started embracing technology for managing deviations, CAPAs and change control where this technology is found in most major companies.

Unfortunately, the industry has been very slow in accepting and embracing validation lifecycle management systems that enable efficiency and cost reduction. Paperless validation lifecycle management systems have been available to the industry for over 10 years and have come a long way to provide full automation of the entire process.

Paperless validation lifecycle management systems enable efficiency, cost reduction and full integration of deviations and change control. Paperless validation lifecycle management systems eliminate the manual activities and inefficiencies that plagued paper-based processes.

Summary

Electronic systems were introduced in the industry over 35 years ago. Early in the lifecycle, electronic systems enabled companies to partially automate document management, change control, data acquisition and deviation processes.