Spectroscopy, 2021-09, Vol.36 (9), p.15-22,58
2021
Details
- Autor(en) / Beteiligte
- Titel
- Does CSA Mean “Complete Stupidity Assured?”
- Ist Teil von
- Spectroscopy, 2021-09, Vol.36 (9), p.15-22,58
- Ort / Verlag
- Monmouth Junction: Intellisphere, LLC
- Erscheinungsjahr
- 2021
- Link zum Volltext
- Quelle
- EZB Electronic Journals Library
- Beschreibungen/Notizen
- The U.S. Food and Drug Administration (FDA) has a new approach to computerized system validation (CSV) called computer system assurance (CSA). Without a draft guidance issued, are we entering an era of regulation by presentation and publication? As a result, does CSA risk becoming “complete stupidity assured?”
- Sprache
- Englisch
- Identifikatoren
- ISSN: 0887-6703eISSN: 1939-1900DOI: 10.56530/spectroscopy.vl2478y4Titel-ID: cdi_proquest_reports_2816733622
- Format
- –
- Schlagworte
- Automation, Compliance, Computer systems, Computers, Data integrity, Design specifications, Documentation, Federal regulation, Good Manufacturing Practice, Government regulation, Industrial development, Laws, regulations and rules, Medical device industry, Medical devices, Medical equipment, Medical technology, Pharmaceutical industry, Pilot projects, Principles, Process controls, Project management, Regulations, Software, Software upgrading, Suppliers, Testing