How ODF Coating Lines Meet FDA 21 CFR Part 11 Compliance Requirements

Introduction: As ODF (Oral Dissolvable Film) dosage forms continue expanding in global markets, the compliance adaptability of production equipment has become a major focus for pharmaceutical audits. Traditional food-grade or semi-automatic coating machines often lack compliance modules, making them unsuitable for regulatory submissions. As one of China’s earliest manufacturers of pharma-grade ODF coating systems, HUANGHAI has addressed Part 11 compliance challenges directly from the system design level.

Compliance Risks in ODF Coating Systems

• Manual recordkeeping of parameter changes without audit trails
• No user login or access control management
• Inability to generate electronic records required for registration
• No data backup mechanism, failing to meet U.S. and EU submission standards

What a Compliant ODF System Must Include

• Traceable data logs for solution preparation, coating, and drying parameters
• User actions bound to permission levels and digital signatures
• Audit trail and data export functions
• Connectivity to system logs and real-time operation charts
• Support for IQ/OQ documentation required for regulatory validation

HUANGHAI’s Compliance-Oriented ODF Line Design

• MJ150 / MJ150-L coating systems integrate full Part 11 compliance modules
• Optional features: thickness measurement, drying curve logging, and tension tracking
• Parameter interfaces and export formats aligned with U.S. and EU registration requirements
• Available with Siemens or Panasonic PLC configurations
• Includes OS screenshots, record templates, and validation document samples

Conclusion

ODF coating systems are not merely production tools — they are part of the regulatory documentation package. Compliance-driven system design is the hidden threshold for competing in the global market. Contact HUANGHAI to request a demo account or sample data template for Part 11-compliant ODF coating systems.