Traditional cleaning system validation is a paper-based very inefficient and time consuming process. Paper-based cleaning validation creates a significant amount of challenges while managing the cleaning validation lifecycle. The following challenges are found in traditional paper-based cleaning validation:
- Silo approach where design and development are not integrated with validation
- Inefficient and inadequate cycle times
- Islands of information in paper, databases and file folders
- Lack of visibility to data and cleaning validation status of equipment
- Paper based execution creates delays and errors
Managing the cleaning validation using paper creates the challenge that there is no integration between the different stages of the cleaning validation lifecycle. This creates the challenge where design and development are managed as separate activities during the lifecycle with no integration with the validation stage. The lack of integration between design, development and validation provides no visibility to the different stages of the lifecycle and the associated data and information found in paper-based documents.
EFFICIENT CLEANING VALIDATION LIFECYCLE THROUGH VALGENESIS VLMS
One of the key benefits of managing the cleaning validation lifecycle in ValGenesis VLMS is the ability to integrate the 3 stages of cleaning validation including Design, Development and Validation as lifecycle process. Managing the cleaning validation lifecycle in ValGenesis VLMS provides the ability to have one single repository data and documentation related to cycle development, cleaning validation studies and performance qualification of the cleaning procedures.
ValGenesis VLMS is a web-based system designed to eliminate the inefficiencies found in traditional cleaning validation lifecycle management. ValGenesis VLMS fully automates the entire cleaning validation lifecycle and enables paperless validation lifecycle management.
The following benefits can be achieved with ValGenesis VLMS when managing the cleaning validation lifecycle:
- Design and development is integrated with validation
- Paperless lifecycle management enables efficiency and cost reduction
- Data integration throughout the entire cleaning validation lifecycle
- Global visibility to data and cleaning validation status of equipment across multiple functional groups and sites
- Paperless protocol execution eliminates challenges associated with paper based validation