How Our Laser Drilling System Supports FDA 21 CFR Part 11 Compliance

Introduction: As osmotic controlled-release tablets (such as Metformin and Nifedipine) become widely adopted, laser drilling systems play a critical role in ensuring consistent release performance. However, for global pharmaceutical markets, hardware precision alone is no longer enough—compliance with FDA 21 CFR Part 11 has become a decisive purchasing factor.

Compliance Challenges in Laser Drilling Systems

• Lack of data recording: Conventional precision laser systems often fail to capture process data, making traceability impossible.
• No user access control: Without permission management or operation logs, audits cannot identify responsibility.
• Untracked parameter changes: Adjustments not linked to user IDs raise concerns about data integrity.
• Missing e-signature functions: The inability to provide secure digital signatures limits acceptance in regulated markets.

Key Functions of a Compliant Laser Drilling System

• Multi-user login with role-based access control (operator, reviewer, administrator)
• Parameter adjustment only after authenticated login, with automatic operation logs
• Comprehensive audit trail for every run and modification—tamper-proof and exportable
• Electronic signature binding each operation to user ID and timestamp
• Report export in regulatory formats (PDF, CSV) for submission or archiving

HUANGHAI’s Solution — The Olando K3-2 System

The Olando K3-2 Pharmaceutical Laser Drilling System integrates Part 11-compliant functionality from design to software:

• Linux-based control system with touch-screen interface, access hierarchy, and audit trail module
• Real-time parameter recording — every drilling session is logged, traceable, and exportable
• Cognex vision system for inline hole detection and image-based verification
• Optional Siemens PLC to align with U.S. and Canadian validation preferences
• IQ/OQ documentation and validation packages available for audit support

Key Takeaway

Precision drilling defines product quality; compliance defines market access. By combining advanced laser control with built-in 21 CFR Part 11 functionality, HUANGHAI enables pharmaceutical manufacturers to achieve both consistency and regulatory confidence.

Learn more about the Olando K3-2 Pharmaceutical Laser Drilling System or contact our team to request a live compliance demonstration and white paper.