Compounding-record redaction is the removal of patient and operator identifiers from a batch sheet. It fits FDA 21 CFR Part 11 for electronic records and signatures. anonym.plus runs locally and keeps the formula, lot, and quantity data.
When this applies
A batch sheet names the patient it was made for and the operator who signed it. For an inspection copy or a teaching set, you clear those two names only.
How anonym.plus handles it
- Open the sheet in anonym.plus on your device.
- It finds the patient and operator names plus codes.
- Dates and electronic-signature names get flagged.
- Confirm the flags; the formula and lot are kept as content.
- Black out items for inspection, or swap them for teaching.
- Save the clean copy; the source stays on your machine.
What you need to provide
- The sheet (PDF, DOCX, or system export).
- An operator (Redact for inspection copies).
- Optional operator map for signature lines.
PHI entity types detected
| Category | anonym.plus entity type | Example |
|---|---|---|
| Names | PERSON | made for J. Marek → [PATIENT] |
| Names | PERSON | operator sign-off → [OPERATOR] |
| Dates | DATE_TIME | compounded 02 Mar → [DATE] |
| Record IDs | MEDICAL_RECORD_NUMBER | batch no. OR-5521 → [BATCH_ID] |
| Identifiers | ID | e-sig hash → [SIG_ID] |
| Location | LOCATION | clean room 3 → [SITE] |
Compliance achieved
- Fits FDA 21 CFR Part 11 electronic records and signatures.
- Keeps the formula, lot, and quantity, which are clinical content.
- Offline work keeps the batch sheet inside your pharmacy.
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Limitations & cautions
Part 11 governs the integrity of electronic records and signatures. The tool removes the patient and operator names from a copy; it does not run your validated system or audit trail. The formula and lot are kept as content.
Frequently asked questions
Is the formula removed?
No. The formula, lot, and quantity are product data, not patient identifiers, so they stay. Only the patient and operator names are taken out.
Does this make my system Part 11 compliant?
No. Part 11 covers your validated record system and audit trail. The tool only de-identifies an exported copy of a batch sheet for safe sharing.
Are electronic-signature names removed?
Yes. The signer's name is flagged, while the integrity controls live in your own system.