Often, organizations use separate systems and processes for change control and variation management. Within Vault, an organization may use a Quality QMS Vault to ensure that a change to a product or system is introduced in a controlled and coordinated manner. The same organization may use a separate RIM Registrations Vault to determine the impacted markets for that change and manage the filing updates and approvals for relevant Health Authorities. In such a case, using separate systems can result in duplicate data entry and a lack of synchronization, which prolongs the process and results in changes that occur without a proper understanding of regulatory impact.
This feature enables organizations using both a QMS Vault and a Registrations Vault to share data about change events that have regulatory impact. The Quality to RIM Vault Connection automates document and data sharing between these two applications, supporting change control initiation, regulatory assessment, and close out.
Note: This connection and its various integration capabilities must be configured by an Admin.
About the Quality to RIM Vault Connection
The Quality to RIM Vault Connection helps to solve several industry challenges that exist for change events, including:
- Regulatory Impact Assessments: When a change control Quality Event or Change Control record is created in QMS, the connection creates an associated Event record in Registrations, including an option to map related impacted detail records such as products, active substances, and more. This allows Registrations users to start the impact assessment process. When the regulatory impact assessment is complete in Registrations, the connection pushes country-level details to QMS.
- Filing Updates: When the change control is approved for implementation in QMS, the connection automatically alerts country users in Registrations that they can begin their filings to get the change approved for all countries and relevant Health Authorities.
- Status Visibility: In QMS, users can gain visibility into the status of regulatory filing updates as updates occur in Registrations.
- Registered Product Transfer: When a Product, Product Family, or Product Variant record is created or edited in RIM, the connection creates or updates the record in Quality. This data can then be associated with change controls.
- Document Exchange: A source Quality or RIM Vault document is transferred with its metadata to the target Vault as a CrossLink. The connection maintains the CrossLink and metadata as the source document undergoes updates and re-enters the Steady state, or enters the Superseded and Obsolete states.
How the Quality to RIM Vault Connection Works
Along with integrations described below, the Quality to RIM Vault Connection also includes the RIM-Quality: Product Integration to maintain RIM product data in Quality. These integrations can run independently or together.
Change Management
The connection’s integration for Change Management enables Vault to create and update records in a Registrations Vault after a user initiates a change event in a QMS Vault:
- The connection starts in the QMS Vault. A QMS user creates a change control Quality Event or Change Control record and determines that there may be regulatory impact. The user then creates a Change Control Impact Assessment record associated with the Quality Event or Change Control. The QMS Vault creates a series of Transaction object records with a status of Pending, which sends a Spark message to the Registrations Vault to start a job to query for all pending Transactions.
- The Registrations Vault processes pending Transactions and creates an Event record with details about the change control.
- A Registrations user then determines the impact of the change control. The Registrations user completes a detailed impact assessment report for the new Event record and creates individual Activity records for each regulatory filing action that needs to occur to incorporate the new change. When the Registrations user moves the Event record to the next state, the Registrations Vault creates a series of Transaction object records with a status of Pending, which send a Spark message to the QMS Vault that starts a job to query for all pending Transactions. The job updates the Change Control and creates Impacted Country records. Once the job is complete, the transaction is marked Complete.
- A QMS user then enters all details for the change management plan, including the regulatory filing actions to be implemented from the Registrations Vault’s Activity records. After the change plan is approved, the QMS user moves the change control Quality Event or Change Control record to the Approved state which creates a Transaction object record with a status of Pending. Vault sends a Spark message to the Registrations Vault to start a job to query for all pending Transactions. The job moves applicable Events to a Ready for Implementation state and marks the Transaction as Complete.
- As each Activity record receives status updates from the related Health Authority, the Registrations Vault creates a Transaction record, which sends a Spark message to QMS to start a job to query for all pending Transactions. The job will update the activity status of the Impacted Country record and mark the transaction as Complete. This allows QMS users to track the filing status for each impacted market.
- When a QMS user marks the Quality Event or Change Control as complete, Vault creates a Transaction record that sends a Spark message to the Registrations Vault to move the related Event to a Closed state.
If at any point during the process, the Quality Event or Change Control moves to a Cancelled state in the QMS Vault, Vault creates a Transaction record in the Pending status that sends a Spark message to the Registrations Vault to move the related Event to a Cancelled state. Once this is complete, Vault marks the transaction Complete.
Document Exchange
The connection’s integration for Document Exchange enables Vault to create and maintain document CrossLinks and metadata across your Quality and RIM Vaults. The document types and fields Vault transfers are determined and mapped by an Admin when configuring the integration. As such, a document in either Vault can be considered to be the source (outbound) or target (inbound) document.
When, for example, a source Quality document reaches its Steady state, Vault creates a CrossLink document in the target RIM Vault and populates metadata accordingly. Once created, Vault maintains the target CrossLink when the source document:
- Undergoes a metadata update while in the Steady state.
- Re-enters the Steady state after revision.
- Enters the Superseded or Obsolete state.
See the use case below and the integration’s limitations for more information.
The diagram below provides a basic overview of this process, as well as the various criteria which must be met in order for a CrossLinked document to be created and maintained in a target Vault.
Document Exchange Use Case
VeePharm classifies master batch records in Quality under the Operations > Master Batch Record document subtype, and in RIM under the Quality > Regional Information > Batch Records (Master/Executed) classification.
These documents’ respective lifecycles map state types to states as follows:
| State Type | Quality State | RIM State |
|---|---|---|
| Steady State | Effective | Approved |
| Superseded State | Superseded | Superseded |
| Obsolete State | Obsolete | Obsolete |
The table below illustrates Vault actions and outcomes for a single Master Batch Record document as it undergoes various document events throughout its lifecycle.
| Quality Master Batch Record document event | RIM Batch Record (Master/Executed) CrossLink result |
|---|---|
| Quality draft document v0.1 routed for approval, entering the Approved state v1.0. | None. Quality’s Approved state is not the Steady state, therefore a CrossLink is not created. |
| Quality document v1.0 moved to the Effective (Steady) state. | RIM CrossLink v1.0 created in the Approved (Steady) state. |
| Quality document v1.1 created and routed for approval. It enters the Approved state (v2.0), then the Effective (Steady) state. Document v1.0 set to the Superseded state. | RIM CrossLink updated to v2.0, remaining in the Approved (Steady) state. CrossLink v1.0 set to the Superseded state. |
| Quality document v2.0 Country document field updated from “United States” only to “United States” and “Puerto Rico”. | RIM CrossLink v2.0 Country document field updated from “United States” only to “United States” and “Puerto Rico”. |
| Quality document v2.0 moved to the Obsolete state. | RIM CrossLink v2.0 moved to the Obsolete state. |
The examples above mostly follow a positive flow, in that document events are encountered and processed as expected. Below are some possible scenarios in which a new or updated Quality Master Batch Record produces different results in RIM.
| Quality Master Batch Record document event | Scenario | RIM Batch Record (Master/Executed) CrossLink result |
|---|---|---|
| A VeePharm Admin is migrating finalized batch records from a local drive, creating a Quality document v3.0 in the Effective (Steady) state. | The document exists only in the Steady state. It does not enter the Steady state from another state during the migration. | None. The integration does not create target CrossLinks for source documents created in the Steady state. |
| Quality document v1.0 up-versioned in quick succession to v2.0, then v3.0. Both versions enter the Effective (Steady) state. | Rapid transition to v3.0 occurs before the connection job processes the transition to v2.0. | RIM CrossLink v1.0 up-versioned to v3.0 in the Approved (Steady) state. Version history reflects versions 1.0, 2.0, and 3.0. |
| Quality document v1.0 up-versioned in quick succession to v2.0, then v3.0. Only v3.0 enters the Effective (Steady) state. | The user deletes Quality document v2.0 before the connection job processes it in RIM. | RIM CrossLink v1.0 up-versioned to 3.0 in the Approved (Steady) state. Version history reflects versions 1.0 and 3.0. |
| Quality document v4.0 moved to the Obsolete state. | RIM CrossLink v4.0 exists, however the RIM Obsolete state type does not have a mapped state. | RIM CrossLink v4.0 remains in its current Approved (Steady) state. Vault generates a User Exception Message. |
| Quality document v3.1 Country field updated from “United States” only to “United States” and “Puerto Rico”. | Quality document v3.1 is in a draft state. | RIM CrossLink v3.0 Country field remains as “United States” only, until the Quality document enters a future Steady state (v4.0) and Vault updates the RIM CrossLink document and metadata. |
| Quality document v1.0’s Country field is empty (null) when the document enters the Effective (Steady) state. | The connection attempts to create RIM CrossLink v1.0 with an empty Country value. | Vault generates a User Exception Message. The Country field is required for this RIM document type. |
How to Sync Updated Change Data
Syncing Changes from Quality to RIM
If the scope of the change control is modified in your QMS Vault, you can sync changes to your Registrations Vault manually:
- Navigate to the Change Control Impact Assessment record in your QMS Vault.
- From the Actions menu, select Update RIM Change Details. This action may only be available in certain lifecycle states, depending on your Vault’s configuration.
- The QMS Vault creates Transaction records with a status of Pending. These transactions send a Spark message to the Registrations Vault to start a job to update the related Event record with new details about the change control. This may include updating fields on the Event record, as well as creating or inactivating related Event join records to align with related records that were added or deleted in the QMS Vault.
When you sync data between Vaults, Vault compares the Quality Event or Change Control record’s ID and the Impact Assessment record’s ID to existing Event records in the Registrations Vault. If an existing Event record references these record IDs, Vault updates the existing record rather than creating a new one.
Syncing Changes from RIM to Quality
Your process may include a reassessment of an event’s regulatory impact during the lifecycle of the change control. When there are changes to the regulatory impact assessment, you can sync updates to your QMS Vault manually:
- Navigate to the Event or Activity record in your Registrations Vault.
- From the Actions menu, select Update QMS Impact Details or Update Impacted Country Details. This action may only be available in certain lifecycle states, depending on your Vault’s configuration.
- The Registrations Vault creates Transaction records with a status of Pending. These transactions send a Spark message to the QMS Vault to create, update, or inactivate Impacted Country records related to the change control. Vault may also update the related Change Control Impact Assessment record in the QMS Vault with details from the Event record in the Registrations Vault.