Jan 15, 2013 1:32 pm EST
KEY POINTS
The following key points are discussed:
Methodology and documentation recommended by FDA to effectively address lifecycle considerations in software development.
Basic principles can be applied to software used in processes, production equipment, facilities, test equipment, and other applications.
“Lifecycle” includes development, initial release, updates, and other activities through final retirement and de-commissioning.
Software is significantly different from hardware in current good manufacturing practice requirements. Software engineering needs an even greater...
This content is only available to IVT members.
Get help maintaining your knowledge in Regulation. Read More!
If you are already a member and you do not have access to this article, upgrade your membership.
Need help? Read our FAQs.
