Maintaining Sample Data Integrity

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Maintaining data integrity is crucial for ensuring that data is readily available for audits, recordkeeping practices meet legal requirements, and organizations’ liability is reduced. This is especially important in Sample Management because sampling is highly regulated and controlled. The following functionality helps maintain data integrity for samples and sample data in Veeva CRM:

To maintain a secure audit trail for sample data, any edits or deletions to Sample Transaction and Sample Order Transaction records are captured via audit records on the Sample_Transaction_Audit_vod and Sample_Order_Transaction_Audit_vod objects, respectively.

For example, Sarah Jones only has access to the data she needs for sample disbursements. She also cannot make edits to submitted records, which would be a compliance issue in her country. Only her manager and the sample admin for her organization can create sampling records on her behalf, and all changes to her submitted records are tracked through audit records.

Ensure initial configuration is complete to use this functionality.

Data Sharing Rules

Data sharing rules help admins grant targeted access to records, so that users do not have an inappropriate level of access to records—for example, viewing records that are restricted, or editing other users’ records. Using data sharing rules, admins grant record access for specific users and roles and can define a limited level of access for each user or role. By default, managers have access to their direct reports’ records through Role Hierarchy. Additional users may also need access to users’ records–for example, users in sample operations or compliance.

To selectively grant access to other roles or groups of users who may need to access sample data, create Sharing Rules. Define the appropriate level of access for each sharing rule.

Users Transferring Products, Creating Product Adjustments, Returning Products, or Capturing Inventories for other users must have Read/Write access to the other users’ sample lot records.

Sample Transaction Audit Records

Sample Management creates a secure audit trail for Sample Transaction and Sample Order Transaction records. Sample Transaction records are created for all sample transactions:

  • Sample transfers
  • Sample receipt confirmations
  • Sample adjustments
  • Sample disbursements
  • Sample returns

Sample Order Transaction records are only created for sample requests/BRC transactions.

When a record on the Sample Transaction or Sample Order Transaction objects is edited, deleted, or archived, the Sample_Transaction_To_Audit_vod Apex trigger generates a mirror copy of the original transaction record and inserts that record to the appropriate audit object. This audit record also captures the name of the user who modified the original record, and the date and time of the edits or deletion. This ensures that the original records and historical data on all changes are available for sample audits.

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