Computer Systems Validation
Traditional computer system validation is an inefficient and time consuming paper based process that is plagued with a significant amount of inefficiencies. Paper-based computer system validation requires that highly skilled technical resources dedicate approximately 50% of their time on non-value added activities which include the following inefficiencies:
- Creating paper-based traceability matrixes
- Printing and executing protocols with pen and paper
- Managing execution deviations through paper-based process
- Scanning documents into file folders
- Routing executed documents for review and approval
Traditional computer system validation requires resources to dedicate a significant amount of effort to create and maintain traceability matrixes during the lifecycle. This creates a compliance risk over time because companies fail to maintain the traceability matrix current during the lifecycle.
Consistency during the CSV lifecycle is another challenge of paper based validation systems. In paper based CSV processes, consistency is highly dependent on the ability to have adequate procedures that can be reliably followed and executed for all CSV lifecycle activities. This is a big challenge, as oftentimes CSV procedures are not well written, making it difficult to enforce consistency. The lack of consistency in the process creates the risk of not being capable of complying with the requirements of approved procedures.
EFFICIENT RISK BASED CSV LIFE CYCLE PROCESS THROUGH VALGENESIS VLMS
ValGenesis Validation Lifecycle Management System (VLMS) enables 100% paperless and fully automates the CSV process from initial validation to retirement and decommissioning. ValGenesis VLMS is capable of managing requirements, conducting risk assessments, generating dynamic trace matrices, electronic execution, and enforcing validation requirements through frameworks. ValGenesis VLMS eliminates non-value added manual activities that are labor intensive and time consuming while expediting the CSV process and removing inefficiencies that plague validation processes completed on paper or through an EDMS. ValGenesis VLMS improves the efficiency of the entire validation process, enhances consistency and reduces the validation cycle time and cost by approximately 50%.
ValGenesis VLMS provides a significant amount of advantages such as:
- Risk based lean validation process
- Reduces validation cycle time and cost by approximately 50%
- Improves consistency
- Integrates full CSV lifecycle management
- Eliminates non-value added activities while increasing compliance
- Approvals are tracked and alerts are sent through e-mail
- Requirements are managed individually as objects
- Dynamic trace matrix generation
- Electronic, manual and automated protocol execution
- Eliminates Data integrity issues