Commissioning and Qualification is a critical regulatory requirement for the life sciences industry. The purpose of commissioning and qualification is to ensure and provide documented evidence that facilities and equipment are qualified based on their intended use. Commissioning and qualification typically.

includes the following activities and deliverables:

  • Commissioning Plan
  • Basis of Design
  • System Specifications – URS, FRS, DS
  • Factory Acceptance Testing (FAT)
  • Site Acceptance Testing
  • Mechanical Checkouts
  • Automation Checkouts
  • Installation Qualification
  • Operational Qualification
  • Performance Qualification

Commissioning and Qualification is performed early in the lifecycle of facilities and manufacturing equipment prior to process validation and GMP manufacturing operations. During commissioning and qualification a significant amount of data and information is generated in paper-based documents. Commissioning and qualification documentation is normally located in paper-based records, and binders that are stored in onsite document archives or offsite storage provided by a third-party vendor.

Unfortunately, data and information generated during commissioning and qualification is not readily available and integrated for easy retrieval and analysis. This create the challenge and risk of not executing and closing out all the required commissioning and qualification activities according to the application procedure requirements.

Changes during commissioning and qualification are normally managed on paper-based records such as a punch-list or engineering change management forms. This creates a significant amount of challenges including the inability to track and close changes according to procedure requirements.

Commissioning and qualification traditionally is a manual inefficient paper-based process that is plagued with inadequate cycle times and high cost. There is a significant amount of challenges and compliance risk associated with traditional commissioning and qualification.

The inefficiencies and high cost associated with traditional commissioning and qualification are related to the following manual activities:

  • Manual execution
  • Printing
  • Executing and scanning documents
  • Archiving

Managing the commissioning and qualification with paper-based documents create a significant amount of compliance risk. The compliance risk associated with paper-based commissioning and qualification includes the following:

  • Unable to enforce procedure requirements
  • Significant amount of Good Documentation Practices issues
  • Lost and misplaced records
  • Inability to track and close out activities and changes
  • Lack of Data integrity
  • Inability to follow approved procedures
  • Releasing unqualified equipment to support GMP operations

Traditional commissioning and qualification can be very challenging due to the inefficiencies, compliance risk, lack of data integration, inability to adequately track and close out activities.

ValGenesis validation lifecycle management systems provide the industry top solution that eliminate all the inefficiencies that plagued commissioning and qualification. ValGenesis eliminates paper based commissioning and qualification documentation and enable the ability to manage and control changes, perform electronic executions, provides a centralized repository of data and information.

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.
Commissioning Plan equipment process validation manufacturing equipment regulatory requirement Validation Lifecycle Management System

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