In the life science industry, all computer systems with GMP impact must be validated. Computer System Validation is intended to provide documented evidence that a computer system meets documented user requirements. User requirements need to be traceable to individual validation test using a traceability matrix. Unfortunately creating a traceability matrix manually is a very inefficient time consuming process that requires a lot of effort to maintain during the computer system validation lifecycle. Managing traceability manually creates the following challenges:

  • Lack of Data integrity
  • Inadequate cycle times
  • Compliance risk due to inability to maintain during the entire computer system validation lifecycle
  • Inability to integrate with change management
  • Good Documentation Practices issues

Changes to computer systems and its impact to requirements is another challenge during the computer validation lifecycle. The challenges are related to the lack of integration between requirements and changes to computer systems during the lifecycle. The lack of integration provides no visibility of the impact and relationship between changes to computer systems and user requirements.
The inefficiencies and challenges related to managing requirements and traceability matrixes manually during the computer system validation lifecycle negatively impact the process and creates the following business risk:

  • Loss revenue
  • Higher operational cost
  • Inefficient cycle times
  • Resource constraints

Managing requirements and traceability matrixes manually is very challenging because it is a very inefficient, time consuming process that requires a significant amount of resource commitment from the computer validation team. Managing the traceability matrix manually creates delays in releasing critical GMP computer system for production use. In paper-based computer validation requirements, data and information is not readily available for review and change impact assessments during the lifecycle. Requirements data and information resides in binders that fail to provide data integration and a centralized repository of computer validation records including requirements and traceability matrixes.
ValGenesis is a Validation Lifecycle Management solution that provides the ability to manage requirements electronically as objects in the database. Managing requirements as objects in the database provides the ability integrate and develop the traceability matrix electronically and dynamically during the computer validation lifecycle. ValGenesis dynamic traceability matrix eliminates the inefficiencies and compliance risk found in manual paper based traceability matrixes. ValGenesis provides a change management module that enables the ability of managing changes at the requirement and system level. ValGenesis eliminate all the inefficiencies found in paper based computer validation and enable the ability to perform electronic executions, requirements management, dynamic traceability matrixes and integrated change management.

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 electronic executions requirements management traceability matrixes Validation Lifecycle Management

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