Based on our 22+ year experience at multiple life sciences clients implementing quality solutions, TSG has developed a common set of requirements for implementing a Quality Management System (QMS). For our clients, we often use this as a starting point when discussing goals of the new system. We have updated these requirements for those clients looking to implement the Veeva Vault QMS module and are happy to provide this as a free starting point to other Veeva customers. As this requirements document will continue to grow over time as Veeva Vault QMS is enhanced, please check back for updates!
Sample requirements Include:
- Document Creation and Editing
- Change Package
- Search
- Lifecycle
- Review Workflow
- Approval Workflow
- Inbox
- Audit Trail
- Rendering
- Promote to Effective
- Promote to Superseded
- Obsolete Document
- Periodic Review
- Security
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