CILAS 21 CFR-11 particle size analyser

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MODELS \ range of measure
(direct access)

EcoSizer \ 0.3– 400 µm
930 \ 0.2 – 500 µm
1064 \ 0.04 – 500 µm
1180 \ 0.04 – 2500 µm
Size Expert
Accessories :
- video camera,
- autosampler,
- alcohol regenerator,
- small volume unit.

ISO 13320
21 CFR-11

FRAUNHOFER / MIE
Reference powders

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THE CFR 21-PART 11 OVERVIEW

• “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 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 (252Kb): http://www.fda.gov/ora/compliance_ref/part11/frs/background/pt11finr.pdf

CILAS SOFTWARE COMPLIANCE TO THE NORM

The CILAS software meets 21CFR-11 requirements. It includes the following features :

• System UserID/Password assigned to each user
• Definition of various profiles that allow to assign specific system functions to a particular person.
• Automatic audit trail generation of key data changes to ensure full traceability of results.
• Optional electronic signatures to approve results.
• 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

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 .

	What’s New
	Come and see our solutions at the following trade shows : (for more details, click on the shows). USA International Conference & Exhibition on Advanced Ceramics & Composites Booth 303 Daytona Beach, FL January 20 - 21, 2009 TMS Annual Meeting Booth 600 San Francisco, CA February 16 - 18, 2009 Pittcon 2009 Booth 938 Chicago, IL March 8 - 13, 2009 Particle Society of Minnesota Roseville, MN March 2009 Regional Refractories St. Louis, MO March 25 -26, 2009 Chicago Catalyst Show Chicago, IL May 12 - 14, 2009 National Catalyst Show San Francisco, CA May 14, 2009 Southeast Catalyst Show Ashville, NC June 7 - 12, 2009 MS&T 2009 Pittsburgh, PA October 25 - 29, 2009 American Association of Pharmaceutical Scientists 2009 Los Angeles, CA November 8 - 12, 2009