Data integrity in pharmaceutical and medical devices regulation operations : best practices guide to electronic records compliance

Data integrity in pharmaceutical and medical devices regulation operations best practices guide to electronic records compliance

Inspection trends -- Electronic records life cycle -- Electronic records related definitions -- Electronic records handling : 21 CFR part 211 -- Electronic records handling : EMA annex 11 -- Relevant worldwide GMP regulations and guidelines -- Trustworthy computer systems -- MHRA guidance -- Electro...

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Bibliographische Detailangaben
1. Verfasser: López, Orlando (VerfasserIn)
Format: UnknownFormat
Sprache:eng
Veröffentlicht: Boca Raton CRC Press/Taylor & Francis, a productivity press book 2017
London CRC Press 2017
New York
Baca Raton
Schlagworte:
Medical informatics > Pharmacy informatics > Medical instruments and apparatus industry > Quality control > Data integrity > Information Storage and Retrieval > methods > Electronic Health Records > organization & administration > Computer Security > standards > Practice Guideline
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Beschreibung
Zusammenfassung:Inspection trends -- Electronic records life cycle -- Electronic records related definitions -- Electronic records handling : 21 CFR part 211 -- Electronic records handling : EMA annex 11 -- Relevant worldwide GMP regulations and guidelines -- Trustworthy computer systems -- MHRA guidance -- Electronic records governance -- Procedural controls for handling E-records -- Electronic record controls : supporting processes -- Electronic records controls : records retained by computer storage -- Electronic record controls : during processing -- Electronic record controls : while in transit -- Electronic records and contract manufacturers -- Electronic records and Cloud computing -- Self-inspections -- Electronic records remediation project
Beschreibung:Includes bibliographical references (page 357-363) and index
Beschreibung:xxii, 372 Seiten
Diagramme
26 cm
ISBN:9781498773249
978-1-4987-7324-9