When hospitals began implementing their electronic medical records/electronic health records systems (EMR/HER) the pharmaceutical companies that were conducting clinical trials at those hospitals wanted to sue the date from those systems instead of having the hospitals enter the data in their EHR systems and also in the study data entry system. However, the FDA regulations would require that the hospital systems be "validated". The hospitals and the companies developing the systems argued that was "over-regulation." HIMSS published their Developer Code of Conduct where they said instead they would use Quality Management techniques.
This book covers how to use Quality Management (ISO 9001) to develop computer systems, specifically EMR systems. It gives a basic introduction to how to implement computer systems. It also covers the topic of compliance because the hospitals are required to comply with regulations other than FDS regulations.
The book also discusses the topics of risk management and conducting audits, both of which are part of ISO 9001 quality management of computer systems. The book is designed to give the reader an introduction to the things you have to do when implementing a computer system that has to satisfy some standards and where the accuracy of the information could impact the accuracy of a person's medical treatment.
Les informations fournies dans la section « Synopsis » peuvent faire référence à une autre édition de ce titre.
Dick Chamberlain has a PhD in Statistics and has consulted with numerous Pharmaceutical, Contract Research Organizations, and Medical Device companies in the areas of Computer Systems Validation, computerized project scheduling, strategic planning, quality management, and qualification.
He has assisted with the development of all varieties of Standard Operating Procedures and other required documentation for Quality Management, Information Quality, and Compliance to Regulations.
Les informations fournies dans la section « A propos du livre » peuvent faire référence à une autre édition de ce titre.
EUR 17,10 expédition depuis Etats-Unis vers France
Destinations, frais et délaisEUR 10,39 expédition depuis Royaume-Uni vers France
Destinations, frais et délaisVendeur : GreatBookPrices, Columbia, MD, Etats-Unis
Etat : As New. Unread book in perfect condition. N° de réf. du vendeur 29704851
Quantité disponible : 10 disponible(s)
Vendeur : Majestic Books, Hounslow, Royaume-Uni
Etat : New. N° de réf. du vendeur 385620226
Quantité disponible : 3 disponible(s)
Vendeur : GreatBookPricesUK, Woodford Green, Royaume-Uni
Etat : As New. Unread book in perfect condition. N° de réf. du vendeur 29704851
Quantité disponible : 10 disponible(s)
Vendeur : moluna, Greven, Allemagne
Gebunden. Etat : New. Dieser Artikel ist ein Print on Demand Artikel und wird nach Ihrer Bestellung fuer Sie gedruckt. When hospitals began implementing their electronic medical records/electronic health records systems (EMR/HER) the pharmaceutical companies that were conducting clinical trials at those hospitals wanted to sue the date from those systems instead of havin. N° de réf. du vendeur 595392512
Quantité disponible : Plus de 20 disponibles
Vendeur : THE SAINT BOOKSTORE, Southport, Royaume-Uni
Hardback. Etat : New. New copy - Usually dispatched within 4 working days. 458. N° de réf. du vendeur B9781138310209
Quantité disponible : 1 disponible(s)
Vendeur : GreatBookPrices, Columbia, MD, Etats-Unis
Etat : New. N° de réf. du vendeur 29704851-n
Quantité disponible : 10 disponible(s)
Vendeur : Books Puddle, New York, NY, Etats-Unis
Etat : New. N° de réf. du vendeur 26378250973
Quantité disponible : 3 disponible(s)
Vendeur : GreatBookPricesUK, Woodford Green, Royaume-Uni
Etat : New. N° de réf. du vendeur 29704851-n
Quantité disponible : 10 disponible(s)
Vendeur : Revaluation Books, Exeter, Royaume-Uni
Hardcover. Etat : Brand New. 138 pages. 9.25x6.14x0.51 inches. In Stock. N° de réf. du vendeur __1138310204
Quantité disponible : 1 disponible(s)
Vendeur : Biblios, Frankfurt am main, HESSE, Allemagne
Etat : New. N° de réf. du vendeur 18378250967
Quantité disponible : 3 disponible(s)