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Is OFS-Flow ISO Compliant and does it have version control?

OFS-Flow is ISO compliant and ensures robust data integrity with auditing capabilities. These features allow users to track the lifecycle of a form, specifically identifying any changes made after a record has been finalised (dismissed).

Tracking Post-Dismissal Amendments

In highly regulated environments, transparency regarding data modification is critical. OFS-Flow tracks these through specific metadata and reporting columns:

  • 'Changed After Dismissal' Column: Within OFS Analytics (Flow Manager), users can add a specific column to their reports to identify forms that were edited after their initial completion.

This provides auditors with a high-level view to quickly filter for and investigate amended records.


 

The Audit Log

For every Flow form raised, the system maintains a detailed Audit Log. This log is essential for ISO audits as it captures the "who, what, and when" of every change.

The audit log records:

  1. User Identity: The specific OFS user who made the change.

  2. Action Performed: Whether the form was created, transitioned to a new workstate, or if data fields were modified.

  3. Value History: The log captures the "from" value and the "to" value, allowing auditors to see exactly what the data was before and after an amendment.

  4. Timestamp: Every entry is tagged with a precise Unix millisecond timestamp, providing an irrefutable timeline of events.

Version Tracking

While OFS-Flow provides the technical infrastructure to record data, Version Control management is a customer-led process. To maintain ISO compliance, customers should implement the following control measures:

  • Manual Version Assignment: When a form template is updated (e.g., a change in a temperature threshold or a new compliance question), the customer should manually update the version number within the Alert Message or an info text field.

  • Change Log Maintenance: Customers are responsible for maintaining an external "Form Register." This register should document the reason for the change, the authoriser, and the date the new version was deployed to the OFS Console.

  • Archive Management: When a new version of a form is uploaded to the Alert Configuration, the previous JSON schema should be archived by the customer to ensure a historical record of what the form looked like at any given point in time.

Auditing Version History in OFS

Even though the customer manages the versioning policy, the OFS system provides the irrefutable evidence required by auditors to verify that the policy is being followed:

  • Configuration Snapshots: Auditors can verify which specific configuration was active at the time of an entry.

  • Consistency Checks: By comparing the customer’s internal "Form Register" against the createTime and configUID in the OFS Audit Log, auditors can confirm that only approved, current versions of forms were in use on the factory floor.