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Types of Validation Processes in the Life Science Industry

Blog Home | Published: October 12, 2016

Validation is a global regulatory requirement for the life science industry. Validation is defined by the FDA as a process that is required to establish documented evidence which provides a high degree of assurance that a specific, system, equipment, computer system or process will consistently meet the requirements and its intended use. In the life science industry all systems, computers, equipment and processes that have GxP impact require validation.

In the life science industry, the following processes and systems are subject to validation requirements

  • Computer Systems
  • Laboratory Instruments
  • Analytical Methods
  • Manufacturing Processes
  • Manufacturing Equipment
  • Shipping
  • Cleaning and Sterilization (CIP/SIP)
  • Packaging
  • Fill and Finish Manufacturing Processes
  • Traditionally validation is managed as a paper-based process.

Paper-based validation is very inefficient and requires a significant amount of resources to print, scan, archive, review and approve validation documents. Paperless validation systems eliminate the inefficiencies that plagued paper-based validation processes.

Summary

Validation is defined by the FDA as a process that is required to establish documented evidence which provides a high degree of assurance that a specific, system, equipment, computer system or process will consistently meet the requirements and its intended use.