Vault RIM Playbook: Labeling, Content Plans, Quality Change and the Active Dossier
Vault RIM playbook
Labeling, Global Content Plans, change control between Vault Quality and Vault RIM, and the Active Dossier. How the process runs, what Vault gives you, and what to check in your own vault.
Four areas where the data and the process drift apart
CCDS and local labeling in Vault RIM: document types, lifecycles, labeling events, and moving existing documents across without losing the market or the history.
Planning a change once against an Event, then dispatching it so each affected market gets its own plan to complete.
The delivered link between a Vault Quality change control and a Vault RIM Event, and how to check it works in both directions.
What is approved where today: how the rows get there, why they go stale, and how to correct them from the approval letters.
One thing worth knowing about each
Labeling
Reclassifying a document applies the new lifecycle’s sharing settings to every version. Check that the people who rely on old versions can still open them.
Global Content Plans
If the Global Application picker is empty when you create a plan, you are missing a Global Application record. Most people first take it for a permissions problem.
Quality–RIM change
There are seven delivered integration points, four from Quality to RIM and three back. If the Quality-to-RIM messages fail, change controls close while the regulatory side still shows in progress.
Active Dossier
If rows come from content plans and nobody runs the objective calculation, the rows marked current reflect the plan and may not match what was approved.
Vault functionality covered
Read-only queries to baseline your data before anyone proposes a fix
Bulk creates and updates of records and document fields, tested on a small batch first
Moving documents to a new type and lifecycle with their versions intact, and setting status directly during a migration
Rules that stop an Event or Activity moving on before the records under it are ready
Template structure, item document types and matching rules, which every plan copies
The product and substance joins, and the calculation that turns approvals into Active Dossier rows
The Vault-to-Vault messages between Quality and RIM, and where the failed ones end up
Moving configuration from sandbox to validation to production, compared before deployment
Adding a manufacturing site in five markets
The playbook follows one invented change through all four areas. A company adds a drug product manufacturing site for a tablet approved in five markets. Quality raises the change control and the integration creates the RIM Event. RA assesses every registration that names the current site, which releases the quality change plan. One Global Content Plan covers the shared 3.2.P content and is dispatched to the five market submissions. As each approval letter arrives, the Regulatory Objective is approved and the Active Dossier is updated for that market. The PDF goes through all eight steps and where each one tends to go wrong.
What you get, and how we work
What you get
With a Vault Advisory subscription:
- A named advisor who gets to know your vault and your SOPs
- Regular hours for questions, fixes, configuration and data work
- A review of each Vault release against your configuration
- A read-only Vault Health Check across these four areas
- Our Vault Knowledge System for your team
How we operate
On every engagement:
- We start read-only and baseline your data first
- Sandbox, then validation, then production, through your change control
- A dry run you approve before any data changes
- Work to your SOPs, with the validation evidence
- We tell you when a change isn’t worth making
The Vault RIM playbook
For regulatory affairs, regulatory operations, RIM data stewards and Vault business admins.
- How the four areas connect, and the Vault functionality behind them
- Labeling in Vault RIM: decisions and reclassification
- Global Content Plans: why the first attempt stalls
- Change control between Vault Quality and Vault RIM: the seven integration points
- The Active Dossier: why it goes stale and how to correct it
- Worked example: adding a manufacturing site
- Working with DnXT
Frequently asked
Do I need admin access to run the self-checks?
No. Every check can be answered by reading records, reports and audit trails.
What is a Vault Advisory subscription?
A named DnXT advisor who knows your vault, regular hours for questions and fixes, a review of each Vault release against your configuration, a read-only Vault Health Check, and access to our Vault Knowledge System. Contact us for details.
Do you change our production vault?
Only through your change control, after the change has been built and tested in a sandbox and validated. Data changes run in batches you approve from a dry run.
Is DnXT affiliated with Veeva?
No. DnXT is independent. Veeva and Vault are trademarks of Veeva Systems Inc.
Want this done in your vault?
A Vault Advisory subscription puts a named advisor on your team, with regular hours, a review of each Vault release against your configuration, and access to our Vault Knowledge System.
