The Validation Project function available in ValGenesis provides users with the ability to easily manage complex validation projects with the required quality gate checks and task dependencies. The purpose of the quality gate check approach is to force document-to-document dependencies (e.g. URS needs to be approved before authoring the OQ) or system-to-system dependencies (e.g. validating the infrastructure before validating the software). With the quality gate check approach, ValGenesis enhances compliance and improves consistency in the validation process across the organization.
Any project that is created in the system can be assigned to project managers who will be responsible for managing the entire project and so they can easily assign tasks and document deliverables. Through the real-time reporting capabilities embedded in ValGenesis system, project managers can easily track the status of project deliverables and locate bottlenecks in real-time with any project and process. Tracking documents on paper projects and on an SMEs basis, provides project managers with tremendous control over the validation process, allowing them to manage projects efficiently.
- Define projects by including multiple assets and processes with well-defined phases.
- Enforce dependencies between deliverables and systems or processes that are part of a project.
- Establish well defined quality gate checks from project inception to completion.
- Provide project managers with a high degree of control over any project.
- Provide Gantt charts with dynamic status updates.
- Allow project managers to locate bottlenecks in the project