“21 CFR Part 11 compliant”

“21 CFR Part 11 compliant”


With the assistance of Labtronics, Camet Research has implemented controls for a closed system to comply with FDA Title 21 Code of Federal Regulations (21 CFR Part 11) "Electronic Records; Electronic Signatures." The FDA requires all electronic records that are created, modified, maintained, archived, retrieved, or transmitted to be compliant with Part 11 in order to ensure data integrity.

Part 11 regulates software validation, audit trails, record retention, and record copy to ensure that all data recorded will not be subject to user manipulation or intervention. Camet's closed system consists of a dedicated X-ray powder diffractometer linked to a secure workstation. Through the controlled access of the workstation and the use of Labtronics' LimsLink software, the system provides an electronic signature to every diffraction record (diffracted intensity with corresponding diffraction angle) captured.

 

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CAMET Research, Inc.
An X-Ray Diffraction (XRD) Laboratory
6409 Camino Vista #F, Goleta, CA 93117, USA
Phone: (805) 685-1665
Fax: (805) 685-9082
E-mail: camet@camet-lab.com
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