In the pharmaceutical, biotechnology and medical device industry equipment validation traditionally is a manual inefficient paper-based process that is plagued with bottle necks and high cost. The inefficiencies found in traditional equipment validation are related to manual activities such as routing documents for review, approval, printing, scanning, storing and archiving paper-based equipment validation documents. There is a significant amount of challenges and compliance risk associated to paper-based equipment validation. The compliance risk related to paper-based equipment validation include the following:

  • Data integrity
  • Inability to enforce and follow approved procedures
  • Difficult to enforce and execute against the equipment validation master plan
  • Unable to enforce consistency
  • Challenges related to standardizing and harmonizing the validation process across sites
  • Good Documentation Practices issues
  • Lost and misplaced records
  • Regulatory observations

The inefficiencies and high cost associated with paper-based equipment validation is related to the following manual activities:

  • Creating
  • Printing
  • Executing and scanning validation
  • Archiving
  • Document control resources

The inefficiencies that negatively impact paper-based equipment validation processes also create business risk which includes the following:

  • Loss revenue
  • Higher operational cost
  • Higher expenses (document storage, archiving, retrieval, resources)
  • Inability to release manufacturing equipment
  • Delayed production schedules

Paper-based equipment validation is very challenging because it is a very inefficient, time consuming process that requires a significant amount of resource commitment from the validation and document management teams. Paper-based equipment validation creates delays in releasing critical equipment for manufacturing operations. In paper-based equipment validation data and information is not readily available for review and assessments during the lifecycle because it resides in binders that fail to provide data integration and a centralized repository of equipment validation records
Validation Lifecycle Management Systems provide a solution to eliminate all the inefficiencies that plagued paper-based equipment validation processes. Validation Lifecycle Management Systems eliminate paper based equipment validation protocols and enable the ability to perform electronic executions, a centralized repository of data and information during the lifecycle of GMP equipment.

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.
Equipment Validation equipment validation processes Traditional Equipment Validation

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