Validation continues a manual inefficient paper-based process in the life science industry. Paper based validation creates a significant amount of challenges for the industry due to the inefficiencies in the process. These challenges include inefficient cycle times and higher operational cost for the industry.
Another challenge includes compliance risks such as failure to follow or difficulty in enforcing approved procedures, lack of consistency and difficult to standardize the validation process across the sites, documentation issues, and misplaced records.
Resources in the industry are wasted creating, printing, scanning, and archiving paper-based computer validation documents.
Unfortunately document management systems are not adequate to manage the validation lifecycle, due to the need to print, scan, and archiving validation documents. Document management systems are also inadequate because they don’t provide the ability to execute protocol electronically. Document management systems only automate the review and approval of validation documents prior to execution. Unfortunately, after the execution is completed the process is manual, inadequate and inefficient.
Electronic document management systems lack data integration and traceability, which leads into islands of information that don’t integrate computer system validation lifecycle data and information, and they don’t provide the ability to maintain periodic reviews.
Paperless systems eliminate the inefficiencies and compliance risk found in paper-based validation processes. Paperless validation applications enable a web-based system that manages the entire validation lifecycle process, including electronic execution.
Technology eliminates the need to dedicate resources to execute manual activities such as printing, scanning, and archiving validation documents.
Validation systems significantly reduce the cycle time by automating critical computer system validation activities, eliminates manual activities that are labor intensive and time consuming and removing the inefficiencies that plague paper-based validation processes.
Paperless validation systems provide full visibility about the validation lifecycle status of qualified systems. Validation systems will improve efficiency, enhances consistency, reduces cycle time by approximately 50%, and enables cross-functional collaboration across multiple sites.
Provide the following functions that enable efficiency and cost reduction:
- Requirements Management
- Dynamic Trace Matrices
- Risk Manager
- Validation Plan
- Protocol Developer
- Test Executor
- Off-line Execution
- Exception and Deviation Management
- Equipment Inventory
Provide the following efficiencies:
- Efficient cycle times
- Full equipment lifecycle management
- Reduced validation effort
- Increased compliance
- Electronic protocol execution
Paperless validation systems enable a single repository for all computer system validation activities across multiple geographic locations. Approvals are tracked and email alerts are sent to document reviewers and approvers. Metrics are in real-time and users enjoy full visibly across the entire organization.