"Who made the determination on this change's regulatory filing pathway, what was the regulatory basis for that determination, and where is the authorization record?"
Your change control record documents what changed.
It does not document who determined how — or whether — to file.
The change control file is complete. The change is described. Impact assessments are attached. Implementation steps are logged. Regulatory classification is noted.
But the filing determination itself — who concluded that this change required a Prior Approval Supplement, a CBE-30, a CBE-0, or no filing at all, and what regulatory analysis governed that conclusion — is not captured as a documented authorization event.
- Change control form documents the change, not the filing determination rationale
- Regulatory classification exists as a selection, not a documented analysis
- The individual accountable for the filing determination is not explicitly identified
- No formal record of the evidence reviewed before the determination was made
Filing pathway decisions are regulatory commitments. An incorrect determination — whether a required supplement was filed, whether notification was timely, whether the change required agency review — is among the most consequential errors an organization can make. The authorization record for that determination must be as defensible as the determination itself.
If an investigator questioned a filing decision from last year, could you defend it?
For a significant change implemented at your site in the past year, could you produce a record identifying who made the regulatory filing determination, what regulatory guidance they applied, what product and manufacturing evidence they reviewed, how they evaluated the impact on approved conditions, and why the chosen filing pathway — or the decision not to file — was the formally justified conclusion under the applicable regulatory standard?
If the determination lives in a regulatory affairs email thread, a verbal decision among team members, or a checkbox on a change control form, it is not an authorization record. It is a decision without documentation. Under inspection, that distinction determines the outcome.
A Decision Defense Record for change control filing captures the regulatory determination as a formal authorization event: the filing decision being made, the regulatory basis governing the determination, the evidence reviewed before the decision was made, the risk and impact evaluation applied, the authorization rationale for the chosen pathway, and the residual regulatory exposure formally accepted.
The record is issued at the moment the filing determination is made, locked with a verification fingerprint, and permanently attributable to the individual who made the regulatory call. It does not replace the change control file. It creates the authorization record that the change control file cannot produce.
Upload your change control evidence and regulatory basis documentation. The system drafts the filing determination authorization record. You review, edit, and authorize.
Get the Change Control Filing Determination Case File
Scenario-specific. Shows exactly what your authorization record is missing and what a defensible record looks like for this decision.