Complete compliance with 21 CFR part 11 — CountWire System for the LUNA-FX7
2 Feb 2021With advancing technology and the subsequent increase in electronic record keeping, the demand for electronic data protection and security is more prevalent. To ensure the accuracy, reliability, authenticity, and consistency of electronic records the United States Food & Drug Administration established Title 21 also known as 21 CFR Part 11, to regulate electronic records and electronic signatures.
Discover how the features and functions of the CountWire™ System connected with the LUNA-FX7™ satisfies the requirements of 21 CFR Part 11 to support regulated institutes to carry out audits, system validations, electronic signatures, and more.
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LUNA-FX7™ Automated Cell Counter
Logos BiosystemsThe LUNA-FX7™ is our most powerful cell counter to date, with unmatched cell counting accuracy, new 1, 3 and 8-chamber slide options, state of the art optics, dual fluorescent and brightfield detection, and precision autofocus. The LUNA-FX7™’s new features such as the Bioprocess mode, Quality Control mode, and the CountWire™ (21 CFR Part 11 compliant) software will help companies and facilities meet and surpass quality and regulatory requirements.