Understanding the Requirements for QSM 5.4.7.2
September 19-22, 2016 -- Labtopia's Jeanne Mensingh will present at the 2016 Analytical Services Program, managed by the Department of Energy Office of Environment, Health, Safety, & Security.
Date/Time: 9/21/16 @ 4:00 pm (50 minute presentation)
Presenter: Jeanne Mensingh
The requirements in QSM 5.0 Section 5.4.7.2 address security, software and computer hardware. In order to adequately assess compliance for these requirements, it is important to know the right questions to ask and what type of objective evidence is needed. This discussion will cover each part of QSM 5.4.7.2 with examples of compliance. Main topics for discussion will include the following items.
- Security awareness training
- Inspections of the LIMS system
- Moving to the Cloud? Does this require notification?
- What is required for defining software development methodologies?
- What is required for validation documentation?
- How is virus protection different from intrusion detection? Can you have one without the other?
For more information contact Tamara Perry at tperry@labtopiainc.com