Source: http://blog.wonderware.com/2015/12/best-practices-for-meeting-fda-21-cfr.html
Timestamp: 2019-08-21 04:40:33
Document Index: 344909536

Matched Legal Cases: ['art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art-11', 'art 11']

Wonderware: Best Practices for meeting the FDA 21 CFR Part 11 regulations with Wonderware Software
Electronic Signature: A gathering of any symbol(s) executed to be the lawfully tying likeness an individual's manually written mark executed to be the legally binding equivalent of an individual’s handwritten signature.
Features of Your Software System - In accordance with 21 CFR Part 11 there is a range of characteristics that you are required to have in place when implementing a software application to manage electronic records and processes. For example: Audit trail functionality, electronic signatures, security and data integrity, records retention and file formats are to name but a few.
Standard Operating Procedures - As with all regulated industries, the companies that operate within them use Standard Operating Procedures (SOP’s) to govern and describe how they are to do things.
While not directly subject to regulation under 21 CFR Part 11, Wonderware System Platform, InTouch, and Wonderware Historian products incorporate features and functionality designed to facilitate the development of applications for use in FDA-regulated industries. Accordingly, Schneider Electric Software has made available this document to provide customers with a set of "best practices" in regards to certain Wonderware products and the 21 CFR Part 11 requirements.
Wonderware System Platform, InTouch, Historian, and procedural controls can be used to implement systems that comply with the FDA's 21 CFR Part 11 regulation.
The Beginners Guide to 21 CFR Part 11 - Montrium." N.p., n.d. Web. 26 Dec. 2015, http://blog.montrium.com/blog/the-beginners-guide-to-21-cfr-part-11
Wonderware InTouch(R) Software FDA 21 CFR Part 11