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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 system processes and eliminate the need to use paper documents. The inability to eliminate paper-based processes created a significant amount of inefficiencies, data integrity risks, and compliance issues with document record retention requirements.

In the last 15 to 20 years, the technology has matured and can fully automate the following processes:

  • Validation lifecycle management 
  • 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 to move away from paper. Over the last 20 years, the industry started embracing technology for managing deviations, CAPAs, and change control, and the technology is found in most major companies.

Unfortunately, the life sciences industry has been very slow to accept and embrace validation lifecycle management systems that enable efficiency and cost reduction. Paperless validation lifecycle management systems have been available 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 and cost reduction and eliminate the manual activities that plague paper-based processes.

Summary

Electronic systems were introduced in the industry over 35 years ago. In the last 15 to 20 years, the technology has evolved into full automation of quality system processes including validation.