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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
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| 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.
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| 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 . |
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What’s New |
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Come and see our solutions at the following trade shows : (for more details, click on the shows).
USA ............................
 American Association of Pharmaceutical Scientists
Washington - USA
23 - 27 October
EUROPE ......................
European Coating Show
Hall 9 - Booth 9-266
Nuremberg - GERMANY
19 to 21 October
www.european-coatings-show.com/de/default.ashx
Analytica 2012
Booth A2-532
Munich - GERMANY
17 to 20 April
www.analytica.de/en/Home
11th World Filtration Congress
Booth F7
Graz - AUSTRIA
16 to 20 April
Achema 2012
Booth 4.2 J50
Frankfurt - GERMANY
18 to 22 June
www.achema.de/index.php?selectedArea=1&selectedItem=1&spkz
ASIA ..........................
Indian Pharmaceutical Congress
Bangalore - INDIA
16 - 18 December
www.ipapharma.org
2012 Annual Meeting of the Taiwan Polymer Society
Chungli - TAIWAN
16 - 17 January
membrane.cycu.edu.tw/E_index.htm
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