Standard Operating Procedure for eCTD Dispatch Logs and Audit Trail Maintenance
| Department | Regulatory Affairs |
| SOP No. | RA/2026/700 |
| Supersedes | NA |
| Page No. | 1 of X |
| Issue Date | 12/04/2026 |
| Effective Date | 12/04/2026 |
| Review Date | 12/04/2028 |
Purpose
This SOP describes the standardized process for maintaining eCTD dispatch logs and audit trails to ensure accurate, complete, and secure documentation of electronic Submission activities related to the electronic Common Technical Document (eCTD). It supports the control objective of traceability, accountability, and compliance with regulatory submission requirements and Good Documentation Practices (GDP) within Regulatory Affairs.
Scope
This procedure applies to all activities related to the preparation, verification, issuance, recording, and archival of dispatch logs and audit trails for electronic submissions (eCTD) managed by the Regulatory Affairs department. It encompasses all electronic submission packages intended for regulatory agencies, regardless of product type or geographic region. Activities excluded include paper submissions and non-regulatory electronic document handling.
Responsibilities
- The Regulatory Affairs Executive responsible for eCTD preparation and dispatch shall execute the logging and audit trail documentation as per this SOP.
- The Quality Assurance (QA) department shall review and verify the accuracy of dispatch logs and audit trails periodically.
- The Regulatory Affairs Manager shall supervise compliance with this procedure and approve dispatch logs for each submission batch.
- The Document Control personnel shall ensure retention and archiving of dispatch logs and audit trails as per the applicable records retention policy.
Accountability
The head of Regulatory Affairs is accountable for implementation, ongoing compliance, reviewing effectiveness, escalating non-compliances, and ensuring regular review and update of this SOP aligned with regulatory and internal quality requirements.
Procedure
1. Preparation and Prerequisites:
Ensure all submission package documents are finalized, validated, and approved per submission requirements prior to dispatch.
Confirm access rights to the eCTD repository and dispatch log templates are current and accurate.
2. Dispatch Log Maintenance:
a) For each eCTD submission dispatched to regulatory agencies, complete the Dispatch Log capturing pertinent details including submission identifier, date/time of dispatch, medium used (e.g., secure FTP, email), recipient contact, package version, checksum/hash values, and responsible personnel initials.
b) Record any amendments, resubmissions, or follow-up dispatches with clear referencing to the original submission.
3. Audit Trail Documentation:
a) Maintain a detailed electronic or hardcopy audit trail capturing all changes, access, reviews, or dispatch events associated with each eCTD submission.
b) The audit trail must include timestamped entries, user IDs, description of actions performed, and justifications for changes or deviations.
4. Verification and Review:
a) Perform a monthly or submission cycle audit of dispatch logs and audit trails for completeness and accuracy by QA personnel.
b) Investigate discrepancies or missing information promptly with relevant Regulatory Affairs personnel.
5. Acceptance Criteria:
All logs must be legible, complete, signed or electronically authenticated, and stored securely with restricted access.
Traceability between dispatch events and supporting documentation must be evident and verifiable.
6. Handling Deviations:
Any deviations or non-conformances identified during maintenance of dispatch logs or audit trails must be documented, investigated, and subjected to corrective and preventive action (CAPA) as per the Quality Management System.
7. Approvals and Documentation:
All completed dispatch logs must bear supervisory approval prior to submission dispatch finalization.
Ensure all records are promptly filed in the official Regulatory Affairs document management system following version control protocols.
8. Record Retention and Closure:
Maintain dispatch logs and audit trails for a minimum retention period aligned with regulatory expectations and organizational policy, typically 5 years or longer if required.
At the conclusion of the retention period, records should be disposed of securely in accordance with data privacy and quality management procedures.
Abbreviations
- eCTD: electronic Common Technical Document
- GDP: Good Documentation Practices
- QA: Quality Assurance
- CAPA: Corrective and Preventive Action
Documents
- eCTD Dispatch Log Template (Annexure-1)
- eCTD Audit Trail Record Form (Annexure-2)
- Deviation Report Form (Annexure-3)
References
- ICH M2 eCTD Specifications and Guidance Documents
- FDA 21 CFR Part 11 – Electronic Records; Electronic Signatures
- EMA Guideline on Electronic Submissions
- Good Documentation Practices (GDP) as per GMP Guidelines
- Internal Quality Management System Documentation Control Procedures
Version
1.0
Approval
| Prepared By | |
| Checked By | |
| Approved By |
Annexures
Annexure-1: eCTD Dispatch Log Template
Purpose: To record complete details of each eCTD submission dispatched for regulatory review ensuring traceability and accountability.
| Field | Example Data |
|---|---|
| Submission ID | eCTD-2026-0425-01 |
| Date of Dispatch | 25/04/2026 |
| Time of Dispatch | 14:35 |
| Dispatch Method | Secure FTP |
| Recipient Agency | FDA |
| Recipient Contact | regulatory@fda.gov |
| Package Version | 1.0 |
| Checksum / Hash | 9F2D3C4B1A6E7F8D |
| Dispatched By (Initials) | RAE |
| Supervisor Approval (Initials) | RAM |
| Remarks | Initial submission for NDA |
Annexure-2: eCTD Audit Trail Record Form
Purpose: To maintain a detailed record of all electronic events related to eCTD submissions, including changes, accesses, and dispatch actions.
| Date & Time | User ID | Action Performed | Description / Reason |
|---|---|---|---|
| 24/04/2026 10:15 | RAE | Created Submission Package | Initial assembly of document set |
| 24/04/2026 16:40 | RAM | Reviewed Submission Package | Quality and completeness check |
| 25/04/2026 14:35 | RAE | Dispatched Submission | FTP upload to FDA portal |
| 25/04/2026 15:00 | RAM | Recorded Dispatch Log Entry | Confirmed checksum and receipt |
Annexure-3: Deviation Report Form
Purpose: To document any deviations identified during eCTD dispatch log or audit trail processes and initiate corrective actions.
| Field | Example Data |
|---|---|
| Deviation ID | DEV-RA-2026-051 |
| Date of Deviation | 26/04/2026 |
| Reported By | RAE |
| Description of Deviation | Checksum mismatch detected post dispatch |
| Immediate Action Taken | Resent submission package with corrected checksum |
| Root Cause Analysis | File transfer interruption caused corruption |
| Corrective Action | Verified connectivity and transferred again |
| Preventive Action | Implemented pre-transfer connectivity checks |
| Reviewed By | QA |
| Approval Status | Closed |
Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
| 12/04/2026 | 1.0 | Initial issue | New SOP creation |