Introduction
In life sciences, maintaining data integrity, auditability, and compliance is essential. Veeva Vault, a cloud-based content management platform, helps companies in regulated sectors like pharmaceuticals and biotechnology efficiently manage their content while meeting stringent regulatory requirements. One of Vault's standout features is Soft Deletion, which offers flexibility in handling content without sacrificing traceability or compliance.
In some Vault suites, Soft Deletion is available by default and can be activated with minimal configuration adjustments. However, in most other suites where standard Soft Deletion isn't available, a custom Soft Deletion solution can be developed and implemented.
What is Soft Deletion?
Soft Deletion in Veeva Vault is a method by which a document or object is marked as "deleted" but is not permanently removed from the system. Instead of being completely erased, the document remains in the system in a non-visible or restricted state, allowing users to restore it if needed. This feature provides a safety net for users, ensuring that accidentally deleted items can be recovered and that records of deletion are maintained for audit purposes.
How Soft Deletion Works
When an item is soft deleted in Veeva Vault, it goes through the following stages:
Mark as Deleted: The document or object is flagged as deleted. It is no longer visible in the default views for most users.
Retention in the System: Even though the item is flagged as deleted, it is still retained in the Vault database, allowing administrators to view or recover it if necessary.
Recovery Option: Administrators and authorized users can restore the item back to its original state, making it visible and usable again without any data loss.
Audit Trail: Every action related to the soft deletion, including who deleted the item and when, is recorded in the Vault’s audit logs. This ensures full traceability and meets regulatory requirements for data integrity.
Why Use Soft Deletion?
The soft deletion feature brings multiple benefits to organizations working within Veeva Vault:
Accidental Deletion Recovery: In a fast-paced environment, documents may sometimes be mistakenly deleted. Soft deletion allows for quick and easy recovery, saving time and effort in recreating lost content.
Audit and Compliance: Regulatory bodies such as the FDA require full traceability of all actions performed on regulated content. Soft deletion retains audit information, ensuring compliance with these standards.
Data Integrity: Vault maintains the integrity of the data by ensuring that deleted content can still be accounted for. There’s no risk of accidental permanent loss without going through an approval process.
Reduced Risk: Since soft-deleted items are not completely removed, there is a lower risk of losing valuable information that may still be relevant for audits, research, or other purposes.
Differences Between Soft Deletion and Permanent Deletion
While soft deletion retains the document in the system, permanent deletion completely removes the document and its associated metadata from the Vault. Once an item is permanently deleted, it cannot be restored. However, for regulatory reasons, permanent deletion is restricted to specific users with the appropriate permissions. This ensures that content is not inadvertently removed without proper oversight.
Key Differences:
Soft Deletion: Item is flagged as deleted but remains in the system. It is recoverable.
Permanent Deletion: Item is completely removed and cannot be recovered.
How to Implement Soft Deletion in Veeva Vault
Soft deletion is typically configured by system administrators. Here's a general overview of how it is implemented:
Configuration: Administrators can set up soft deletion workflow within Vault to define what happens when documents are deleted and design the process flow of Soft Deletion. This may include setting timeframes for retention and deciding which user roles have access to recover deleted items.
Permissions: Only users with specific permissions can soft-delete or recover documents. This adds an extra layer of control, ensuring that only authorized personnel can make significant changes. This includes, Permission restriction in Lifecycle states, DAC Configurations, SDK Implementations, etc.
Restoration: If a document needs to be restored, administrators can quickly restore it and make it visible for end users.
Conclusion
Soft Deletion in Veeva Vault is a robust feature that enhances the platform’s compliance, flexibility, and data protection capabilities. It offers organizations the ability to manage documents more safely, ensuring that no valuable data is lost through accidental deletions. Simultaneously, it maintains the strict audit and regulatory standards required in highly regulated industries, such as life sciences.
By utilizing soft deletion, companies can manage their data with greater confidence, knowing that their content is both secure and recoverable when needed.
Want to learn more about how Soft Deletion in Veeva Vault can benefit your organization? Contact us for more information or assistance!
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