Can Pharmaceutical Testing Instruments Meet FDA 21 CFR Part 11? Yes—Here’s How

Introduction: Testing instruments—such as dissolution, disintegration, hardness, and friability testers—form a core part of regulatory submissions. Increasingly, authorities require traceable electronic records and access control. FDA 21 CFR Part 11 has become a key benchmark for judging an instrument’s compliance capability.

Where traditional instruments fall short

• Paper-only printouts with no electronic archiving or traceability
• No user login, making it impossible to identify the operator
• Insufficient data protection—records can be manually altered
• Data authenticity questioned during registration or customer audits

What Part 11 requires for testing instruments

• Role-based access control: record the operator and timestamp for each action
• Automatic saving: store test results, run logs, and calibration records
• Electronic signatures: bind records to user identity and lock original data
• Audit trail: who, when, and what—tamper-evident and reviewable
• Standard data export: provide formats (e.g., PDF/CSV) for audit and archiving

HUANGHAI’s compliance upgrades

HUANGHAI provides a full range of testing instruments with Part 11-ready options. See the portfolio here: Pharmaceutical Testing Instruments.

• SY-6DN Intelligent Multi-Purpose Tablet Tester with Part 11 module support — product page: SY-6DN Intelligent Tablet Multi-Purpose Tester
• Interface localization: English/Chinese UI; configurable multi-user roles
• Data security: automatic encryption and scheduled backups for all operations/results
• Validation support: IQ/OQ documentation, operator training, and log/report templates

Conclusion

In today’s pharmaceutical environment, compliance is a baseline feature for both production equipment and laboratory instruments. HUANGHAI delivers a one-stop bundle—equipment plus compliance enablement—to help teams accelerate registration with auditable, traceable, and secure data flows.