Analytical Method Validation
Analytical method validation is a global regulatory requirement in the life sciences industry. During the lifecycle, analytical methods are revised and optimized to improve the performance of critical attributes such as precision, accuracy or linearity. During the lifecycle, any changes to analytical methods require revalidation to ensure that they perform as intended and meet the acceptance criteria for all critical attributes. The challenge for the industry is efficiently managing all these changes and information during the lifecycle of analytical methods.
Traditional analytical method validation is a paper-based process where technical data resides in protocols, notebooks, forms, unprotected spreadsheets and technical reports. This creates a significant amount of challenges for scientist managing the analytical method lifecycle. Some of the challenges found in traditional paper-based cleaning validation are the following:
- Silo approach
- Lack of data integration between analytical method development and validation
- Islands of information in paper, databases and file folders
- Inefficient and inadequate cycle times
- Lack of real-time visibility to validation status of analytical methods
- Paper based execution creates delays and errors
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 analytical method lifecycle and enables paperless lifecycle management.
One of the key benefits of managing the analytical method lifecycle in ValGenesis is the ability to integrate analytical development and validation in one integrated system. Managing the analytical method lifecycle in ValGenesis provides the ability to have in one single repository of data and documentation related to method development, and validation studies.
The following benefits can be achieved with ValGenesis VLMS when managing the analytical method validation lifecycle:
- Analytical method development data, information and records are integrated with validation
- Paperless analytical method lifecycle management enables efficiency and cost reduction
- Paperless execution eliminates challenges created with paper based validation
- Real-time validation status of analytical methods during the lifecycle
- Enforce the method validation requirements as per the approved validation procedure and processes