With the ValGenesis system, change management and validation are integrated in order to achieve a completely closed loop change management process. The change management module within ValGenesis follows industry standards and guidelines. ValGenesis manages the change requests and relates the impact of the changes to lifecycle deliverables that are generated in the system. Through the ValGenesis system, users are not only able to manage the change management process but they are also able to see the validation impact and deliverables required as result of the change. Required validation deliverables are authored and executed within ValGenesis. At the time of final closure of the change request, all impacted approved validation documents will be available for change request approvers to view before final closure approval.
- The Change Control module in ValGenesis was designed in alignment with industry standards
- The system offers a high degree of flexibility in terms of allowing users to define one-to-many change request processes, which more closely matches their existing change control procedures. Through the ability to create multiple change request processes, ValGenesis can manage any type of change request efficiently.
- Configurable process maps available within the system determine how a change request should be handled once it has been reviewed by the change review board. Any type of change request can be managed within the system with a customization requirement.
- ValGenesis’ change management is the only system that links impacted validation documents to changes.
- ValGenesis provides an integrated change control process allowing users to track changes and impacted document deliverables associated with the change.
- By linking the impacted document deliverables to change requests, the system provides users with a simplified mechanism to see how changes impact validation/controlled documents and how it tracks 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 for the change control process.