Beckman Coulter’s New Line of Centrifuges Provides Support for 21 CFR Part 11 Compliant Laboratories

As technology and software advance, security and protection of data is becoming increasingly important to ensure a properly functioning lab environment. In this regard, many laboratories are requiring the
use of regulations for storage and protection of electronically stored data and the application of electronic signatures. “Part 11 of Title 21 of the Code of Federal Regulations; Electronic Records; Electronic
Signatures” (21 CFR Part 11) provides a set of U.S. federal regulations for data protection. These regulations are being adopted by many laboratories to ensure that electronic records are accurate, reliable,
authentic, and consistent.

Beckman Coulter’s new line of centrifuges—the high-performance Avanti JXN and the ultracentrifuge Optima XPN—offers solutions to support 21 CFR Part 11 regulations, making it easy to use Beckman
centrifuges and remain compliant.

Persons who use open systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, as appropriate, the  confidentiality of electronic records from the point of their creation to the point of their receipt. Such
procedures and controls shall include those identified in 11.10, as appropriate, and additional measures such as document encryption and use of appropriate digital signature standards to ensure, as necessary under the circumstances, record authenticity, integrity and confidentiality.

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