CLSI AUTO11 P : 1ED 2006
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
10-31-2006
01-12-2013
Abstract
Committee Membership
Foreword
1 Scope
2 Definitions
2.1 Acronyms
3 Delineation of Vendor and HCO Responsibilities
4 Technical Design Guidelines Related to Regulatory
Requirements
4.1 Preventing Unauthorized Application Usage
4.2 Preventing Unauthorized Data Access
4.3 Protection From Malicious Software
4.4 Security Monitoring
4.5 Preventing Loss of Data
5 Process and Operational Requirements
5.1 IT Security Requirements Engineering and
Management
5.2 IT Security Hazard Analysis and Risk Management
5.3 Vendor System Validation/Verification
5.4 Vendor Security Audits/Assessments/Tests
5.5 Documents for HCO
5.6 Preventive Actions (software patches, virus
definitions)
6 Applicability to Device Classes
References
Additional References
The Quality System Approach
Related CLSI/NCCLS Publications
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.