Logos Biosystems’ Official Launch of the CountWire™ System, Compliant with 21 CFR Part 11

2021-02-05

 

 

February 5, 2021

 

Logos Biosystems’ New CountWire™ System Makes Your Lab Completely Compliant with 21 CFR Part 11.

 

Logos Biosystems, a leading provider of innovative life science solutions, part of Aligned Genetics, Inc., has officially launched the CountWire™ System. The CountWire™ System enables Logos’ newest and most advanced cell counter, the LUNA-FX7™, to become 21 CFR Part 11 compatible.
The System has 3 parts: the CountWire™ Client software installed in PCs, CountWire™ Data Storage, and the CountWire™ operating system for the LUNA-FX7™ Automated Cell Counter. The CountWire™ System allows multiple instruments to be connected to the same network, controlled multi-user access, and remote and secure data management.

The CountWire™ System completely supports 21 CFR Part 11 compliance by providing fully functional:

 

• User Management
• User Access Control and Role Assignment
• Verifiable Electronic Signatures
• Audit Trails
• Data Safety, Security, and Integrity

 

According to the CEO of the company, Dr. Neon Jung, “With evolving technology and the subsequent growth in electronic record keeping, the demand for electronic data protection and security is more prevalent, and the United States Food & Drug Administration established 21 CFR Part 11 to regulate electronic documents and electronic signatures. We strongly believe that the LUNA-FX7™ powered by CountWire™ will be an optimal cell counter that can fully serve the spectrum of cell counting needs from research labs to production facilities while meeting rigorous regulatory guidelines”.

 

Learn more about the CountWire™ and its compliance in the white paper available on our website >>

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