In the life science industry computer validation is typically a manual paper-based process that is plagued with inefficiencies and high cost. The inefficiencies are related to manual activities such as printing and scanning computer validation documents. There is a significant amount of challenges and risk related to paper-based computer validation such as the compliance risk associated to paper. The compliance risk related to paper-based validation include the following:

  • Failure to follow approved procedures
  • Difficult to enforce the approved validation procedures and validation master plan
  • Lack of consistency
  • Difficult to standardize and harmonize the validation process across sites
  • Documentation issues
  • Lost and misplaced records
  • Regulatory observations

The inefficiencies that plagued paper based computer 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

The inefficiencies and high cost associated with paper-based computer system validation is mostly based on the need to perform the following activities:

  • Creating
  • Printing
  • Executing and scanning validation
  • Inefficient cycle times
  • Archiving
  • Document control resources

Paper-based computer validation is very challenging because it is a very tedious, time consuming process that requires a significant amount of resource commitment from the validation and document management teams. Paper-based validation creates delays in releasing critical manufacturing equipment for manufacturing operations. Record retention can be very costly and unsustainable during the lifecycle.

Validation Lifecycle Management Systems provide a solution to eliminate all the inefficiencies that plagued paper-based computer validation processes. Validation Lifecycle Management Systems eliminate paper based computer validation protocols and enable the ability to perform electronic executions.

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.
computer system validation computer validation Paperless Validation

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