Integrated Change Management – Application Lifecycle Management
In today’s demanding business climate, change is unavoidable for enterprise systems like SAP, Oracle ERP, LIMS, MES, etc. Currently, any change to a single user requirement or system requirement will impact all related validation documents including design specification, test cases, etc. As per the regulatory requirements and as a good practice, each change requires impact assessment and a plan to mitigate the impact. Each change also requires significant effort to update/revise all validation documents and processes associated with the change. When there are many change requests for the same system at the same time, the process will be complicated thus requiring a large number of cross functional users to be involved in managing the change control process and validation documents. With advancement of technology, there is a better way to handle these changes efficiently with minimal effort.
ValGenesis ALM’s integrated change management approach helps to track changes more closely with much tighter focus on 4Ws.
- What is the risk associated with this change request?
- What is the process flow to be adopted based on the risk level, priority and severity?
- What impact do these changes have on other related validation documents/contents?
- Who are the stake holders and responsible users that manage the change control process including initiating, impact assessment, implementing the change, validating the change and approving the closure?
ValGenesis Validation centric ALM provides full control over the change management, which helps ensure its quality, validated status, efficiency and timeliness with minimal effort:
- ValGenesis provides an integrated change control process allowing users to track changes and impacted validation and other related document deliverables associated with that change.
- By linking the impacted document deliverables to the change request, the system provides users a simplified mechanism to see how changes impact validation/controlled documents in addition to tracking the status of those documents in real time.
- ValGenesis provides a high degree of control over the change management process. The system maintains a comprehensive audit trail for each change in the system allowing users involved with the change to see the complete genealogy of the change control process.
- Maintains transparency throughout the lifecycle of the change control process.
- Helps to stay in compliance, enforces consistency and improves productivity.
- Enables the ability to truly assess the cumulative impact of changes to validated applications.