CILAS : english version
  
 

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CILAS LASER Particle sizing and shape analysis GRANULOMETRIE
CILAS LASER Particle sizing and shape analysis CERTIFICATIONS
Particle size instrument

Retour accueil général Retour accueil général


Certification BVQI

Particle sharpe NORME CFR 21-PART 11

CILAS LASER Particle sizing and shape analysis


The CFR 21-PART 11 Overview Le laser

21 CFR Part 11 Electronic Records “21 CFR Part 11 Electronic Records; Electronic Signatures; Final Rule” (Federal Register 62, no. 54, 1997), further referred to as the 21CFR11 regulation, is a regulation that has been issued by the United States Food and Drug Administration (FDA). This regulation outlines criteria for accepting electronic records and signatures applied to these records. The regulation was effective on August 20, 1997. All industries regulated by the FDA must comply with these regulations.
The basic principle is to ensure that electronic records The basic principle is to ensure that electronic records and signatures are equivalent to paper records and handwritten signatures. The primary concerns of the FDA in issuing this regulation were to maintain the trustworthiness, reliability and integrity of the electronic records and signatures which are used in lieu of paper records and handwritten signatures.
The complete text can be downloaded on the FDA web site The complete text can be downloaded on the FDA web site (252Kb): http://www.fda.gov/ora/compliance_ref/part11/frs/background/pt11finr.pdf

CILAS software compliance to the norm Le laser

The CILAS software meets 21CFR-11 requirements. It includes the following features :
The basic principle is to ensure that electronic records System UserID/Password assigned to each user
The basic principle is to ensure that electronic records Definition of various profiles that allow to assign specific system functions to a particular person.
The basic principle is to ensure that electronic records Automatic audit trail generation of key data changes to ensure full traceability of results.
The basic principle is to ensure that electronic records Optional electronic signatures to approve results.
The basic principle is to ensure that electronic records User defined reporting formats which reference calibration and other important analysis parameters.

A detailed compliance statement document is available on request. Contact us.

The IQ, OQ, PQ procedure Le laser

CILAS proposes to customer an « IQ, OQ, PQ » procedure with the corresponding « Workbook » for instrument qualification recording.

The QUALIFICATION PROCEDURE and the WORKBOOK are available. Contact us.




   
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