Salesforce validation is the process of establishing and maintaining documented confidence that a specific Salesforce organization and the applications running on it are fit for their defined regulated use.
A Salesforce implementation may fall within GxP scope when its intended use supports regulated processes, records, decisions, or controls. The organization should document the intended use, system boundary, GxP scope, and required assurance activities through its approved risk-based methodology.
Salesforce provides platform controls, documentation, release information, and other supplier evidence that customers may leverage. This evidence does not by itself establish that a customer’s Salesforce configuration, integrations, installed packages, permissions, data model, automation, and workflows are fit for that customer’s intended GxP use.
Salesforce delivers three seasonal releases each year: Spring, Summer, and Winter. These automatic upgrades make release assessment an important element of validated-state maintenance for GxP uses of the platform. Installed packages and connected applications may follow separate release schedules and should be managed through the applicable change process.
Automation can support Salesforce assurance by comparing metadata or configuration, identifying changes, maintaining traceability, and generating or updating validation records. Human review remains important for confirming regulatory relevance, risk, and the appropriate assurance response.
Frequently Asked Questions
Does Salesforce come pre-validated?
No. Salesforce supplies platform controls and documentation that may be leveraged as supplier evidence. The regulated company must still establish that its specific organization, configuration, integrations, installed applications, and workflows are fit for intended GxP use.
How often does a Salesforce org need to be validated?
The implementation should be assured before regulated use and maintained through change management. Applicable Salesforce releases, package updates, integrations, and internal configuration changes should be assessed for GxP impact. Additional testing or validation should be performed where the assessment determines it is necessary.
What parts of a Salesforce org fall under validation?
The scope should include the functions, configurations, data, interfaces, controls, permissions, automation, and installed components relied upon for the defined GxP intended use. The documented system boundary and risk assessment should determine the precise scope.
Can Salesforce validation be automated?
Automation can support metadata comparison, change identification, impact assessment, traceability, and generation or maintenance of validation records. Expert review and approval remain necessary for regulatory scope, risk, and assurance decisions.