Commissioning and Qualification in the Life Sciences


In the life sciences industry, commissioning and qualification (C & Q) are critical processes associated with the manufacturing of pharmaceutical and biotechnology products. 

Commissioning is essential for the successful start-up and transfer of facilities, utilities, systems, and equipment. Its main purpose is to guarantee that all design and user requirements are effectively met.

Qualification aims to demonstrate the suitability and proper functioning of facilities, utilities, systems, and equipment for their intended use. 

Commissioning and Qualification Typically Include 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 are performed early in the facilities and manufacturing equipment lifecycle before 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 usually in paper-based records and binders stored in on-site document archives or off-site storage facilities provided by a third-party vendor.

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

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

Traditionally, commissioning and qualification is a manual, inefficient, paper-based process plagued with inadequate cycle times and high costs. A significant compliance risk is associated with traditional 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 process manually poses substantial compliance risks such as:

  • The inability to enforce procedure requirements.
  • Good documentation practices (GDP) issues.
  • Lost or misplaced records.
  • The inability to track and closeout activities and changes.
  • A lack of data integrity.
  • The inability to follow approved procedures.
  • The possibility of releasing unqualified equipment to support GMP operations.

Manual commissioning and qualification can be very challenging due to the inefficiencies, lack of data integration, and inability to adequately track and closeout activities.

ValGenesis validation lifecycle management system (VLMS) provides the industry's top solution for eliminating all the inefficiencies that plague commissioning and qualification. ValGenesis eliminates paper-based commissioning and qualification documentation and enables the ability to manage and control changes, perform electronic executions, and provide a centralized repository of information.

The opinions, information and conclusions contained within this blog should not be construed as conclusive fact, ValGenesis offering advice, nor as an indication of future results.