quick outline from first view.,
ER/ES for Clinical Investigations - Q&As
... Key points.
ELECTRONIC SYSTEMS....
* 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
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
* 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