In 2011, FDA published a new guidance for the industry on Process Validation: General Principles and Practices. This guidance aligns process-validation activities with the product life-cycle concept which moves from the current 3 batch process to a 3-stage process requires significant changes with traditional validation process and approach. Traditional process validation is a paper-based inefficient and time-consuming process. Paper-based process validation lifecycle creates a significant amount of challenges while managing the process validation lifecycle as per the new process validation guidance. The new process validation guidance recommends, the collection, evaluation of data from the process design stage through commercial production, which establishes evidence that a process is capable of consistently delivering quality product. It is nearly impossible to adopt and manage the new process validation process without the use of adequate software systems and analytics tools.

The following challenges are found with manual process validation:

  • Difficult to find critical process and product lifecycle data related to design and development
  • Process design/development stage is not integrated with validation stage
  • Product lifecycle data found in disparate systems
  • Inefficient and inadequate knowledge management from Design to Qualification and to Continuous process verification.
  • Paper based Process Performance Qualification (PPQ) creates data integrity issues, delays and errors
  • Lack of visibility to product lifecycle data across the organization

Manual paper-based process validation lifecycle management creates the challenge that there is no integration between the different stages of the product lifecycle. In manual process validation, activities of design stage are managed as separate activities during the lifecycle with no integration with the validation stage. The lack of integration provides no visibility to the different stages of the product lifecycle and the associated data found in paper-based documents. The lack of visibility during the product lifecycle creates the challenges related to understanding the process validation data, and technical details.

ValGenesis Validation Lifecycle Management System enables the ability to manage paperless and integrate the 3-stage process validation lifecycle approach. ValGenesis provides the ability to have a central repository for all data and documentation related to product design, development and validation. This provides a significant amount of advantages because all the lifecycle data resides in one location instead of binders and paper documents that are not integrated in one single repository.

The following benefits can be achieved when managing the process validation lifecycle in ValGenesis VLMS:

  • Continuous Process Verification stage is integrated with Design and Qualification stages
  • Paperless lifecycle management enables efficiency and cost reduction
  • Data integration throughout the entire process validation lifecycle
  • Global visibility to data and process validation status of product across the manufacturing network
  • Integrated knowledge management across the Lifecycle stages
  • Statistical analysis at any stage of the process validation lifecycle stages
  • Paperless execution eliminates challenges created with paper based validation

ValGenesis provides a solution that eliminate all the inefficiencies that plagued paper-based process validation. ValGenesis eliminates paper based process validation activities and enable the provides an integrated centralized repository of data and information during the process validation lifecycle.

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.
Continuous Process Verification paperless process validation Process Validation

Leave a Comment

Your email address will not be published. Required fields are marked *

Archive
x