Run DSCSA Product Tracing and T3 Documentation Inspection — Free

Inspection Scope and Record Set

Inspection period and product scope documented

Sample set includes inbound and outbound transactions for covered prescription drugs

Note (optional)

Inspection records available for the full retention period critical (required)

Yes No N/A

Responsible person or department identified for DSCSA record control

Transaction Information and T3 Completeness

Transaction information includes product identifier, lot number, and transaction date critical (required)

Yes No N/A

Transaction statement present for each reviewed transaction critical (required)

Yes No N/A

Transaction history traceable through prior ownership or distribution events critical (required)

Yes No N/A

Product identifier matches the item received or shipped critical (required)

Yes No N/A

Serialized data and lot data are legible and consistent across source documents

Yes No N/A

Any missing or discrepant T3 elements are logged and escalated critical (required)

Yes No N/A

Receipt, Storage, and Access Control

Transaction records are stored in a controlled system or secured file location critical (required)

Yes No N/A

Access to DSCSA records is restricted to authorized personnel critical (required)

Yes No N/A

Records are backed up or otherwise protected from loss

Yes No N/A

Record indexing allows retrieval by product identifier, lot number, or transaction date

Yes No N/A

Retention controls prevent premature deletion or overwriting critical (required)

Yes No N/A

Verification, Exceptions, and Suspect Product Handling

Discrepancies between product and transaction records are investigated critical (required)

Yes No N/A

Suspect product is placed on hold or quarantined pending verification critical (required)

Yes No N/A

Exception log includes date, product identifier, issue description, and resolution status

Yes No N/A

Notification to trading partners or internal stakeholders is documented when required

Yes No N/A

Corrective actions are assigned with owner and due date

Yes No N/A

Traceability Review and Sign-Off

Reviewed transactions can be traced end-to-end without unexplained gaps critical (required)

Yes No N/A

Inspection findings documented with supporting evidence references

Yes No N/A

Inspector signature captured critical (required)

Management review or owner acknowledgment captured

Reference standard cited in review notes

Get your results

Enter your email — we'll send you a PDF of your filled-out template, plus the occasional MangoScoop newsletter (templates, workflow tips, product updates). Unsubscribe anytime — link is in every email.

Email (required)

Your name (optional)

Run: DSCSA Product Tracing and T3 Documentation Inspection

Inspection Scope and Record Set

Transaction Information and T3 Completeness

Receipt, Storage, and Access Control

Verification, Exceptions, and Suspect Product Handling

Traceability Review and Sign-Off

Get your results