Validation(國外工廠驗證參考資料)_圖文

1、NIST History and MissionNational Institute of Standards and Technology(NIST was created in 1901 as the NationalBureau of Standards (NBS. The name waschanged to NIST in 1988.NIST is part of the U.S. Department ofCommerce with a mission to develop andpromote measurement, standards, andtechnology to en

2、hance productivity, facilitatetrade, and improve the quality of life.$573 for 3 jars NIST supplies over 1,300 Standard ReferenceMaterials (SRMs for industry, academia, andgovernment use in calibration ofmeasurements.NIST defines time for the U.S.DNA typing standardLocation of NIST (near Washington,

3、DCWashingtonD.C.Dulles AirportReagan National AirportBWI AirportAFDILNISTFBILabBaltimore, MDRichmond, VACapitol Beltway(I-495I-270I-95I-95I-66NIST Gaithersburg CampusAdvanced Chemical Sciences Laboratory (Building 227Located in Gaithersburg, Maryland, on approximately 234 hectares (578 acres just of

4、f Interstate 270 about 25 miles northwest of Washington, D.C.Administration (Building 1012,500 staffPete John Margaret Amy Becky Dave DuewerJan NIST Human Identity Project TeamAll NIST publications and presentationsavailable on STRBase:NISTpub.htmCurrent Areas of NIST Effort with Forensic DNAStandar

5、ds Standard Reference MaterialsStandard Information Resources (STRBase websiteInterlaboratory StudiesTechnologyResearch programs in SNPs, miniSTRs, Y-STRs, mtDNA, qPCR Assay and software developmentTraining MaterialsReview articles and workshops on STRs, CE, validation PowerPoint and pdf files avail

6、able for downloadAug 7, 2006Dec 5-6, 2006Apr 3-4, 2007Nov 15, 2006June 8, 2005May 19, 2005Apr 5, 2007Feb 3, 2005June 5, 2007 Profiles in DNA(Sept 1999 3(2: 10-11Quality problems in late 1980s with DNA testingTWGDAM established under FBI Lab sponsorship in 1988NRC I (1992 and NRC II (1996 issued repo

7、rts recommending formal QA programsDAB StandardsText in red font from QualityAssurance Standards for ConvictedOffender DNA DatabasingThe document provides validation guidelines and definitions approved by SWGDAM July 10, 2003. must be observed shoulders, spikes,Developmental Validation ScorecardV a

8、l i da t i o nE x p e r im e n t sA r e S o m e t i m e s D r i v e n b y F e a r o f Au d i t o r s R a t h e r t h a nG o o d S c i e n c eMethod validation provides an assurance of reliability during normal use and is sometime referred to as the process of providing documented evidence that the m

9、ethod does what it is intended to do.accuracy under the stated conditions of the test.”Feinberg et al.(2004 Anal. Bioanal. Chem 3. Internal Validationa total of at least 50 samples(some studies may not be necessaryThe document provides validation guidelines and definitions approved by SWGDAM July 10, 2003.1st Injection (standard for typing15th Injection (treated as a sample-0.75 bp-0.54 bpThese alleles have drifted outside of thei