If your operations involve regulated environments such as pharma, biotech, medical devices, or food safety, you have probably asked: Are data loggers FDA 21 CFR Part 11 compliant? This regulation governs electronic records and electronic signatures, ensuring that digital data has the integrity and traceability expected of regulated processes.
What FDA 21 CFR Part 11 Requires
FDA 21 CFR Part 11 ensures that electronic records including temperature, humidity, or thermocouple logs are reliable, consistent, and secure. You can read the full text of the regulation on the Electronic Code of Federal Regulations.
For how FDA interprets and enforces Part 11, see the FDA guidance Part 11, Electronic Records; Electronic Signatures — Scope and Application.
- User authentication. Each person who accesses, modifies, or downloads data must have a unique user account.
- Audit trails. The system must log who changed what and when including date and time stamps.
- Electronic signatures. Approvals or certifications must be captured in a verifiable way.
- Data integrity. Once a temperature, humidity, or thermocouple reading is recorded, it must be protected against tampering.
- Archival and retrieval. Records must be stored securely for the long term and be searchable in FDA accepted formats.
How Data Loggers Fit Into Part 11
Data loggers capture readings such as environmental humidity, room temperature, or thermocouple measurements in high heat processes. Recording a number is only part of the picture. FDA compliance depends on the end to end system.
- Hardware. The data logger must reliably collect data.
- Software. The application that manages the data must enforce access control, signatures, and audit trails.
- Procedures. Installation, calibration, user training, and record retention must be documented and followed.
Example Use Cases
- Temperature and humidity monitoring. In a GMP cleanroom, a compliant system tracks environmental conditions, with each dataset signed electronically and stored with audit trails.
- Thermocouple monitoring of sterilization. During autoclave or oven cycles, thermocouple loggers capture high temperature data, which is time stamped, traceable, and preserved against post recording edits.
- Cold chain logistics. Portable data loggers capture temperature and humidity during shipments, with complete records retained for inspection.
For updated recommendations in clinical investigations, review the FDA guidance Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations — Questions and Answers.
Finding the Right Data Logger for Compliance
| Feature | Why It Matters |
|---|---|
| Validated software with audit trail | Ensures every action such as downloads, deletions, and edits is logged with identity and timestamp. |
| Role based user access and strong authentication | Prevents unauthorized access or tampering. |
| Electronic signatures and approval workflows | Required for certifying reports or validating process steps. |
| Traceable calibration of sensors | Needed for measurement certainty in regulatory environments, including temperature, humidity, and thermocouple inputs. |
| Secure data export and archival | Records must be stored for required periods, accessible, and in acceptable formats. |
If you want to browse hardware options that can be part of a compliant system, explore IOThrifty data loggers. Models include a range of sensor types, logging intervals, and data export features. Pair the right hardware with validated software and documented procedures to support FDA 21 CFR Part 11 requirements.
Bottom Line
Using a data logger for temperature, or humidity measurements is essential, but not sufficient, for FDA 21 CFR Part 11 compliance. You will need hardware that records data accurately, software that enforces audit trails, electronic signatures, and data integrity, and procedures that document calibration, record keeping, user access, and validation.
For full details, see the official regulation text and the FDA’s Scope and Application guidance.