Compliance with Title 21 CFR Part 11
enLabel Title 21 CFR Part 11 Requirements Checklist
FDA Title 21 CFR Links & Resources
- Part 1, Subpart B — General Labeling Requirements
- Part 11 — Electronic Records; Electronic Signatures
- Part 26 — Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, And Certain Medical Device Product Evaluation Reports: United States and the European Community
- Part 101 — Food Labeling
- Part 201 — Drug Labeling
- Part 203 — Prescription Drug Marketing
- Part 801 — Medical Device Labeling
- Part 803 — Medical Device Reporting; Subpart E — Manufacturer Reporting Requirements
- Part 809 — In Vitro Diagnostic Products for Human Use
- Part 820 — Quality System Regulation
- Part 821 — Medical Device Tracking Requirements
- Part 1271 — Human Cells, Tissues, and Cellular and Tissue-Based Products; Subpart D — Current Good Tissue Practice
- Part 1302 — Labeling and Packaging Requirements for Controlled Substances
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