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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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Pittcon 2012