Paperless Validation

Paperless validation systems were introduced to the industry 10 years ago. Early in the lifecycle of these technology paperless validation system provided standard document management and electronic execution capabilities. This basic functions enabled companies to review, approve and execute electronically validation lifecycle documentation including protocols. Absent from the earlier versions of paperless validation systems was full automation, workflows, and integration with change management.

Over the last 10 years the technology has matured and emerged in providing functionality above and beyond just document management and electronic execution this includes the following:

  • Templates for the different document deliverables
  • Workflows for review and approval for the different process and documents
  • Risk Models to perform system level and requirement level risk assessment
  • Projects to manage validation projects and enforce dependencies
  • Forms to capture and manage data
  • Decision Trees to enforce consistencies in Risk Assessment, Framework Definition and Protocol Development
  • Schedules to manage periodic re-validation and re-verification
  • Change workflow to manage system level and requirement level changes

Although this technology has been available for over 10 years the industry has been very slow in embracing and taking advantage of this technology. In recent years the industry is coming around and looking at paperless validation system as a solution to the inefficient and ineffective paper based validation process. In the next 10 years this technology will evolve into full integration with MES, process control, LIMS and other electronic system that will enable full automation of the entire validation lifecycle process.

About the Author

cloud-sun Ivan Soto is the Director Client Engagement and Product Strategy, he is responsible for managing the product lifecycle, strategy and overall client experience. Ivan Soto has been in the industry for over 20 years, and held several technical and management positions at different Pharmaceuticals companies in the areas of Validation, IT Compliance, Quality Control and Quality Assurance. In his previous role under his leadership, his team successfully implemented a lean validation program. He is an active speaker at conferences related to validation cost reduction and efficiency improvements. He is also a contributing editor for the Journal of GxP Compliance and Validation Technology. He has a (B.S) in Chemistry from the Catholic University of Puerto Rico.
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