News 2008-11-12 Pressetext Österreich ADV-Kompaktseminar "Professionelles E-Mail-Management" am 3. Dezember in Wien E-Mail-Management aus rechtlicher, organisatorischer und technischer... 2008-11-11 Business On VOI stellt 5-Punkte-Programm zur Effizienzsteigerung vor Bonn. Angesichts der aktuellen Finanzkrise und deren Auswirkung auf die wirtschaftliche Gesamtentwicklung stellt der VOI Verband Organisations- und Informationssysteme e. V. einen Maßnahmenkatalog zur Effizienzsteigerung in Unternehmen... 2008-10-07 American Chronicle How Web Document Management Software Empowers Pharmaceutical Companies In the pharmaceutical industry the clock is ticking at the rate of warp-speed 'drug years.' Pharmaceutical industries have 8 (possibly up to 12 years) to discover, conceptualize, define, develop and commercialize--as opposed to market--pre-market drug... 2008-10-04 Pharmaceutical Processing Mastering Software Validation A practical approach Within the life sciences community, the mere mention of the word "validation" sets off discussions filled with validation jargon and acronyms such as IQ, PQ, OQ, predicate rules, GAMP, and other related... 2008-10-04 Pharmaceutical Processing GAMP Standards For Validation Of Automated Systems (Click image for larger version.) GAMP recommends an SDLC called the V-model (see graphic) because it is a commonly used design, but there are others that can be followed. The V-model shows how the three main qualification activities (installation, operation and performance) are linked back to the design... 2008-09-24 Calibre Macro World Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice... Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been... 2008-09-11 Laboratory News LABORATORY COMPLIANCE: MAKING THE GRADE Do you know your calibration from your validation and your verification from your qualification? Paul Smith gives us a handy guide to the often daunting subject of laboratory compliance WHAT is laboratory compliance? It is a general term used by many people, but which means different things to.. 2008-09-08 openPR.de VOI - Prüfkriterien für Dokumenten Management Lösungen neu überarbeitet IT, New Media & Software Pressemitteilung von: VOI e.V. PR Agentur: good news! GmbH (openPR) - Standardwerk mindert Haftungs- und Betriebsrisiken... 2008-07-28 PR inside Announcing IVT's Computer System Validation Conference - The Institute of Validation Technology, a division of Advanstar Communications, has announced its Computer System Validation conference. Computer System Validation... 2008-07-11 IT Business Edge U.S. House Approves New E-Record Archiving Act Remember when all the hullabaloo started over ? In the midst of federal lawsuits filed by the Citizens for Responsibility and Ethics in Washington and the National Security Archive, it came to light that the White House had a horrible electronic recordarchiving...   Login User Name: Password: Remember Login Register Forgot Password ?

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	Downloads   Part11Guidance.pdf Part 11, Electronic Records; Electronic Signatures Scope and Application EU Annex 11(GMP) Computerised Systems OECD GLP-Konsensdokument Nummer 10 Die Anwendung der Glp-Grundsätze auf Computergestützte Systeme ICH Electronic Standards for the Transfer of Regulatory Information(ESTRI) ICH eCTD Electronic Common Technical Document Specification

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