15. Software Systems
Effective Date: 07/2008
Point of Contact: Quality Engineer for Regulatory Programs
This section defines the minimum requirements to be met for software quality assurance and related activities associated with the development, acquisition, and use of software.
Step 1 Project staff comply with the Software subject area, the Safety Software subject area (as appropriate), the Issue Management subject area, and the Unclassified Cyber Security subject area.
Step 2 Project staff use commercially available spreadsheet software and data analysis software as supplied by the vendor if appropriate. Spreadsheets and data outputs from this software are reviewed and tested extensively during the development process. Final spreadsheets and data outputs shall be reviewed as part of the documented analytical data review process (see the Reporting Analytical Data, section) for analytical reports and data packages.
Step 3 Project staff report software errors found during use in accordance with the Issue Management subject area and notify all users.
Step 4 Project staff back up software and electronic data with a frequency commensurate with the risk of data loss or corruption and the cost and ability of data restoration. Project staff select the media and methods used for backup to be suitable and convenient for the data being backed up. Backup may be human-readable (e.g., hard copy paper, microfiche) or machine-readable (e.g., electronic, magnetic, optical).
Step 5 The staff should be responsible for maintaining user operating instructions (e.g., user manuals or online documentation) as needed and appropriate.
Note: In order to minimize laboratory clutter and safety/contamination risks, manuals used only periodically for reference need not be available at the workstation, provided they are readily available to the user. To ensure that only the most current manuals are available, old manuals are discarded when new manuals are received.
References
Issue Management subject area
Software subject area
Safety Software subject area
Unclassified Cyber Security subject area