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2009-01-02 Easy Articles

Web Document Management and a cGMP-Compliant Quality System: Management Responsibilities in the Pharmaceutical Industry

The underlying foundation of any quality system is its associated documentation. Quality system documentation includes policies, procedures and written processes...

2008-12-03 Article Dashboard

Electronic Documents Is The Paperless Society A Practical Reality?

It can be argued that the advent of the computer age and electronic documents is second in importance only to Johann Gutenberg s invention of the printing press in the...

2008-11-22 Compliancemagazin.de

Compliance bei der E-Mail-Archivierung wahren

Worauf es bei einer gesetzeskonformen E-Mail-Archivierung wirklich ankommt Ein E-Mail-Archiv benötigt Sicherheitsfunktionen, die eine Manipulation oder ein versehentliches Löschen von Nachrichten verhindern...

2008-11-20 Food and Drug Administration News

Abstract

Off-the-shelf electronic spreadsheets like Microsoft Excel are widely used in regulated laboratories and production facilities for everything from automating data from laboratory analyses to tracking clinical trials and data...

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..

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