Download or read book Validation d un syst me de gestion de production assist par ordinateur dans l industrie pharmaceutique written by Anne-Sophie Guérin and published by . This book was released on 2004 with total page 124 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book PROPOSITION D UN PLAN DE VALIDATION D UN LOGICIEL DE GESTION DE PRODUCTION ASSISTEE PAR ORDINATEUR written by Daniel Pignard and published by . This book was released on 1995 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book L INSTALLATION D UN LOGICIEL DE GESTION DE PRODUCTION ASSISTEE PAR ORDINATEUR APPLIQUE A L INDUSTRIE PHARMACEUTIQUE written by ANDRE.. BROQUIN and published by . This book was released on 1996 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Pour une gestion de la production assist e par ordinateur dans l industrie pharmaceutique written by Adnen Karmous and published by . This book was released on 1989 with total page 234 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Validation d un syst me informatis de gestion de la production sur un site industriel pharmaceutique written by Emma Thierry and published by . This book was released on 2018 with total page 338 pages. Available in PDF, EPUB and Kindle. Book excerpt: Les systèmes informatisés sont de puissants outils informatiques que les industriels du secteur pharmaceutique utilisent pour fabriquer et distribuer des médicaments de qualité. La validation est la méthode permettant de garantir la fiabilité des logiciels et des fonctionnalités répondant aux besoins des utilisateurs tout au long de leur cycle de vie. Le processus de validation devra être adapté à la catégorie et aux fonctions des logiciels. Au niveau mondial, les différentes agences et organismes responsables de la qualité de ces produits de santé imposent des exigences réglementaires et normatives relatives à l'utilisation de ces logiciels afin de garantir la sécurité des patients. Ils publient des textes réglementaires et des guides qui précisent les activités de validation répondant aux bonnes pratiques de fabrication des médicaments. Par ailleurs, des associations professionnelles publient des recommandations pratiques décrivant les processus de validation des systèmes informatisés. Différents textes tels que le guide des bonnes pratiques de fabrication de l'EMA et de l'ANSM, le guide des bonnes pratiques pour les systèmes informatisés du PIC/S ou de l'EDQM, les directives de la FDA sur les principes généraux de la validation des logiciels sur les enregistrements et signatures électroniques, le guide GAMP de l'ISPE et la directive sur la gestion des systèmes informatisés du Ministère japonais de la santé sont passés en revue et comparés. Les directives sur l'intégrité des données de la FDA et de la MHRA sont également évoquées. Pour illustrer ce processus, un exemple de validation d'un progiciel de gestion intégrée basée sur une analyse de risque sera exposé.

Download or read book CONSTRUCTION DE LA QUALITE DE LA GESTION DE PRODUCTION ASSISTEE PAR ORDINATEUR DANS L INDUSTRIE PHARMACEUTIQUE written by GILLES.. LAPLAIGE and published by . This book was released on 1988 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book GESTION DE PRODUCTION ASSISTEE PAR ORDINATEUR written by MURIEL.. COHEN and published by . This book was released on 1992 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Validation d un syst me de gestion du laboratoire de contr le dans la production pharmaceutique written by Marina Feuvrier and published by . This book was released on 2006 with total page 152 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Mise en place d une gestion de production assist e par ordinateur dans une unit de production pharmaceutique written by Hélène Peine and published by . This book was released on 1990 with total page 214 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation written by Orlando Lopez and published by Taylor & Francis. This book was released on 2018-10-02 with total page 232 pages. Available in PDF, EPUB and Kindle. Book excerpt: Validation of computer systems is the process that assures the formal assessment and report of quality and performance measures for all the life-cycle stages of software and system development, its implementation, qualification and acceptance, operation, modification, requalification, maintenance and retirement (PICS CSV PI 011-3). It is a process that demonstrates the compliance of computer systems functional and non-functional requirements, data integrity, regulated company procedures and safety requirements, industry standards, and applicable regulatory authority’s requirements. Compliance is a state of being in adherence to application-related standards or conventions or regulations in laws and similar prescriptions. This book, which is relevant to the pharmaceutical and medical devices regulated operations, provides practical information to assist in the computer validation to production systems, while highlighting and efficiently integrating worldwide regulation into the subject. A practical approach is presented to increase efficiency and to ensure that the validation of computer systems is correctly achieved.

Download or read book Pharmaceutical Computer Systems Validation written by Guy Wingate and published by CRC Press. This book was released on 2016-04-19 with total page 773 pages. Available in PDF, EPUB and Kindle. Book excerpt: Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification principles and how to put them into practice. To provide the current best practice and guidance on identifying and implementing improvements for computer systems, the text extensively reviews regulations of pharmaceuticals, healthcare products, blood processing, medical devices, clinical systems, and biotechnology. Ensuring that organizations transition smoothly to the new system, this guide explains how to implement the new GMP paradigm while maintaining continuity with current practices. In addition, all 24 case studies from the previous edition have been revised to reflect the new system.

Download or read book INTEGRATION DE PROCEDES DE FABRICATION AU SYSTEME DE GESTION DE PRODUCTION ASSISTEE PAR ORDINATEUR D UNE UNITE DE PRODUCTION PHARMACEUTIQUE written by Olivier Frayssé and published by . This book was released on 1992 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book VALIDATION D UN OUTIL INFORMATIQUE DANS L INDUSTRIE PHARMACEUTIQUE written by ERIC.. FOY and published by . This book was released on 1992 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Objectifs et contraintes de l informatisation des moyens de production dans l industrie pharmaceutiques written by Isabelle Jarry and published by . This book was released on 1993 with total page 162 pages. Available in PDF, EPUB and Kindle. Book excerpt: Les laboratoire pharmaceutiques font appel à un moyen performant pour gérer leur système de production : la gestion de production assistée par ordinateur (GPAO), afin de mieux appréhender l'environnement dit complexe et turbulent dans lequel ils évoluent. L'informatique permet de traiter et analyser toutes les informations internes et externes de l'entreprise. Les améliorations incontestées d'une telle implantation masquent les multiples impératifs et limites de la GPAO, qu'il est important de repréciser.

Download or read book ETUDE DU FLUX MATIERE DANS UN SYSTEME DE GESTION DE PRODUCTION ASSISTEE PAR ORDINATEUR D UNE UNITE DE PRODUCTION PHARMACEUTIQUE written by MATTHIEU.. BAUDARD and published by . This book was released on 1988 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Validation informatique dans l industrie pharmaceutique d marche g n rale et application un logiciel de gestion de la pes e des mati res written by Mathieu Bocquillon and published by . This book was released on 2009 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Mise en place d un syst me de gestion de production assist e par ordinateur au sein des Laboratoires written by Laurent Picot and published by . This book was released on 1992 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: