Use of e-records and e-Signatures in Clinical Investigations Under 21 CFR part 11 Q&A

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quick outline from first view.,
ER/ES for Clinical Investigations - Q&As
... Key points.
ELECTRONIC SYSTEMS....
  • Electronic systems, including commercial off-the-shelf (COTS) and customized
  • electronic systems owned or managed by sponsors and other regulated entities
  • Electronic services, outsourced by the sponsor or other regulated entities
  • Electronic systems primarily used in the provision of medical care
  • Mobile technology
  • Telecommunication systems
CONSIDERATIONS FOR RISK-BASED APPROACH FOR VALIDATIONS.
* purpose&extent of error VS reliability&utility.
* attributes & intended use of electronic system.
* control on changes to e-systems

brief definition of internal&external security safe guards.
* logical and physical access controls
* safeguard data from virus/hacks ... (firewall, antivirus, antispyware)

certain aspects of CLOUD COMPUTING are also clarified. (NIST... “a model for enabling ubiquitous, convenient, on-demand network access to a shared pool of configurable computing resources (e.g., networks, servers, storage, applications, services) that can be rapidly provisioned and released with minimal management effort or service provider interaction.”)


https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM563785.pdf
 

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