Category: 21 CFR Part 11

1. Organizations in the News

   (1 articles) LabVantage

   (1 articles) Informatics at Thermo Fisher Scientific

   (1 articles) Frost & Sullivan

2. People in the News

   (4 articles) Dave Champagne

   (1 articles) Kim Shah

1. New Literature Available for Autoscribe’s Biobank and Biorepository Management ...

   Explore Article prlog.org (Aug 26 2010) Biobanking , Pharmaceuticals , 21 CFR Part 11

   PRLog (Press Release) – Aug 26, 2010 – Autoscribe has released a new brochure describing the use of their highly configurable Matrix Tracker software for biobank and biorepository applications. The software can be ...
   

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2. Software provides validation lifecycle management.

   Explore Article news.thomasnet.com (Jun 8 2009) 21 CFR Part 11

   Besides allowing regulated life science companies to improve upon validation processes, it provides quicker ROI and faster 'ready for service' implementation of commercial-off-the-shelf software applications (ERP, LIMS, DMS, QMS etc. ...
   

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3. Thermo Fisher Scientific To Implement Darwin LIMS at APPPharmaceuticals Inc.

   Explore Article thermo.com (Jun 8 2009) Biotechnology , Environmental , Pharmaceuticals , 21 CFR Part 11 , LIMS

   
   

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4. Laboratory Software serves as electronic lab notebook.

   Explore Article news.thomasnet.com (Aug 19 2009) Pharmaceuticals , 21 CFR Part 11 , ELN, CDS , LIMS

   Laboratory Software serves as electronic lab notebook.ThomasNet Industrial News Room (press release) (press release)"While the instrument side of Agilent helps them generate more and better data, our lab informatics side of the business streamlines the documentation and ...and more »
   

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5. Darwin LIMS Installation at Brazilian Pharmaceutical Powerhouse,Eurofarma

   Explore Article thermo.com (Jun 8 2009) Biotechnology , Contract Labs , Pharmaceuticals , 21 CFR Part 11 , LIMS

   
   

   Comment on Article Mentions:   Dave Champagne

6. Agilent Technologies' New Electronic Lab Notebook Expedites Decisions ...

   Explore Article managingautomation.com (Aug 19 2009) Pharmaceuticals , 21 CFR Part 11 , FDA , ELN, CDS , LIMS

   Agilent Technologies Inc. (NYSE: A) today introduced a major upgrade to its electronic lab notebook (ELN). Kalabie ELN version 4.0 contains new functions to expedite decision-making, manage analytical requests and increase collaboration between ...
   

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7. Instrument Interfacing: Some Observations and Reflections

   Explore Article Scientific Computing (Apr 16 2010) 21 CFR Part 11 , ELN, CDS , LIMS

   Instrument Interfacing: Some Observations and ReflectionsScientific ComputingJohn Joyce is the LIMS manager for Virginia's State Division of Consolidated Laboratory Services. He may be contacted at editor@ScientificComputing.com.and more »
   

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8. Pharsight Signs Anapharm As PKS, WinNonlin AutoPilot Customer

   Explore Article BioResearch Online (Apr 6 2010) Biotechnology , Pharmaceuticals , 21 CFR Part 11 , LIMS

   Pharsight, a market-leading provider of software and scientific services to improve productivity and decision-making in clinical drug development, today announced that Anapharm, a PharmaNet company, an industry leader in early-phase drug development, has selected Pharsight Knowledgebase ServerT (PKST) as its enterprise solution for secure storage and tracking of pharmacokinetic and ...
   

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9. Qualtrax, Inc. Welcomes New Customer: Southwest Louisiana Crime Lab

   Explore Article PR.com (Oct 8 2009) 21 CFR Part 11 , ISO

   Qualtrax, Inc. Welcomes New Customer: Southwest Louisiana Crime LabPR.com (press release)In addition to Qualtrax, the lab uses a Laboratory Information Management System (LIMS) package to manage evidence and technical, case information. ...
   

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10. New Informatics Offerings at Pittcon 2008

    Explore Article thermo.com (Jun 8 2009) Biotechnology , Food & Beverage , Pharmaceuticals , 21 CFR Part 11 , LIMS

    
    

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11. Thermo Scientific Connects at GPSG Brazil Delivers Enterprise-Level Productivity Linking Laboratories to ERP

    Explore Article labmate-online.com (Jun 1 2010) Pharmaceuticals , 21 CFR Part 11

    The Global Pharmaceutical Supply Group (GPSG) Brazil is an APILA unit of Janssen-Cilag Farmacêutica Ltda., (www.janssen-cilag.com. br) located in São Paulo, Brazil. Janssen-Cilag is on...
    

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12. SaaS Model Turns LIMS Paradigm On Its Head

    Explore Article Life Science Leader (May 26 2010) Pharmaceuticals , 21 CFR Part 11

    SaaS Model Turns LIMS Paradigm On Its HeadLife Science Leader Magazine... about its drug compounds and biological samples is what drove one pharmaceutical laboratory to consider a SaaS-based LIMS. The lab performs stability ...
    

    Comment on Article Mentions:   Kim Shah

13. NuGenesis SDMS

    Explore Article Environmental (Jan 31 2010) Pharmaceuticals , 21 CFR Part 11 , ELN, CDS , LIMS

    NuGenesis SDMSEnvironmental Expert (press release)NuGenesis SDMS exchanges data with electronic laboratory notebooks (ELNs), LIMS, EDMS and other common enterprise technology systems. ...
    

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14. A Showcase of New Informatics Offerings at Analytica 2008

    Explore Article labmate-online.com (Jun 8 2009) Environmental , 21 CFR Part 11 , ISO , LIMS

    Thermo Fisher Scientific will showcase its new informatics offerings on 105 204 hall B1 at Analytica 2008 Messegel nde Munich from April 1 4 2008 In keeping with the Moving Science Forward...
    

    Comment on Article Mentions:   Dave Champagne

15. Handheld Equipment Roundup: Portable Pharma

    Explore Article Pharmaceutical Industry (Oct 21 2009) Pharmaceuticals , 21 CFR Part 11 , ELN, CDS

    Handheld devices—rugged, robust, ones—are proliferating in pharma’s plants, labs, and warehouses. Here’s a look at what’s at your fingertips.
    

    Comment on Article Mentions:   Frost & Sullivan

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