Complaint-record redaction is the removal of complainant and patient IDs from a quality complaint file. It fits FDA 21 CFR Part 11 for electronic records. anonym.plus runs locally and keeps the product, lot, and defect detail.
When this applies
A complaint file names the person who reported a defect and any patient harmed. For a quality review, you clear those IDs but keep the product and lot.
How anonym.plus handles it
- Open the file in anonym.plus on your device.
- It finds complainant and patient names plus IDs.
- Dates, contacts, and addresses get flagged.
- Confirm the flags; the product and lot stay as non-IDs.
- Black out items for the review, or swap them for trending.
- Save the clean copy; the source stays on your machine.
What you need to provide
- The file (PDF, DOCX, or system export).
- An operator (Redact for a quality review).
- Optional map for repeat complainants.
PHI entity types detected
| Category | anonym.plus entity type | Example |
|---|---|---|
| Names | PERSON | complainant → [COMPLAINANT] |
| Names | PERSON | patient harmed → [PATIENT] |
| Dates | DATE_TIME | logged 02 Mar → [DATE] |
| Record IDs | MEDICAL_RECORD_NUMBER | complaint no. 9F-22 → [COMPLAINT_ID] |
| Contact | PHONE_NUMBER | 040 555 0190 → [PHONE] |
| Location | LOCATION | home address → [ADDRESS] |
Compliance achieved
- Fits FDA 21 CFR Part 11 electronic records for complaint files.
- Keeps the product, lot, and defect detail, which are not patient IDs.
- Offline work keeps the file inside your quality team.
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Limitations & cautions
Part 11 governs your validated record system, not the swap. The tool de-identifies a copy for safe sharing. The product and lot stay as non-IDs. A rare defect plus a place could still hint at the complainant, so review odd cases.
Frequently asked questions
Is the product or lot removed?
No. The product, lot, and defect detail are quality data, not patient IDs, so they stay. Only the complainant and patient IDs go.
Does this make the file Part 11 compliant?
No. Part 11 covers your validated record system and audit trail. The tool only de-identifies an exported copy for safe handling.
Can repeat complainants stay linked?
Yes. A label map lets one complainant map to one alias across the files you review.