Kloudface: The 21 cfr part 11 compliant laboratory instrument controller

Kloudface: The 21 CFR Part 11 compliant laboratory instrument controller

Kloudface: The comprehensive gatekeeper for laboratory data

In a strictly regulated environment, ensuring data integrity and compliance with regulations like 21 CFR Part 11 is paramount. The KloudFace instrument controller, powered by the integrOS Pro operating system, is designed to be the central nervous system that ensures every action on connected lab instruments is controlled, documented, and compliant.

KloudFace is not standalone software; it is a powerful hardware device that acts as an intelligent gatekeeper, bringing high-level management and security to your workflow.

Why is kloudface the ultimate security and compliance solution?

1. Specialized operating system: integrOS pro

At the heart of KloudFace is integrOS Pro, an operating system built with one goal in mind: compliance. It provides a closed and secure operating environment that fully meets the requirements of 21 CFR Part 11.

2. Multi-level user and access management

• Biometric authentication: An optional upgrade for fingerprint authentication, eliminating the risks associated with password sharing.

• Role-based access control: Supports 200+ users across 10 user-defined roles, ensuring individuals can only perform their authorized functions.

• Authority check: Verifies user and role before permitting any action.

3. A central hub for control and storage

• Multi-instrument connectivity: Capable of connecting to non-chromatographic instruments, making them part of a compliant ecosystem.

• Secure storage: Stores up to 10,000 records and 1,000 methods/protocols.

• Detailed audit trails: Automatically logs all events, which can be filtered by usage, user, service, modification, error, and date.

4. Intuitive interface and connectivity

• 7-inch touchscreen: Makes operation and setup straightforward and easy.

• LIMS/ERP connectivity: Easily transfer electronic data to other systems via open XML formats.

• Flexible printing: Print reports via LAN and RS232 to 40 or 80-column paper.

Key specifications and features

Frequently asked questions (faq) about kloudface

1. Is kloudface a software or a device?

• KloudFace is a hardware device (instrument) that runs the specialized integrOS Pro operating system. It functions as a central controller to manage other instruments in the lab.

2. What is the main purpose of this device?

• The primary purpose of KloudFace is to ensure data integrity and compliance with 21 CFR Part 11 regulations. It manages user access, methods, and logs all activities on the instruments connected to it.

3. What kind of instruments can it connect to?

• The datasheet specifies that KloudFace can connect to “non-chromatographic instruments,” such as Electrolab’s dissolution testers, disintegration testers, friability testers, etc.

4. Is “biometric authentication” a standard or optional feature?

• According to the datasheet, it is an upgradable feature, meaning it is an option that requires a factory upgrade.

Conclusion

The KloudFace instrument is a foundational solution for any laboratory that prioritizes compliance and data security. Instead of managing individual devices separately, KloudFace provides a single, powerful, and compliant point of control, simplifying workflows, minimizing risks, and ensuring that all generated data is trustworthy.