Source: http://eduquest-ions.com/tag/electronic-signature/
Timestamp: 2017-05-23 16:55:40
Document Index: 558718001

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

Tag Archive for Electronic Signature	Windows 10 Validation: How to Handle Validation of Monthly Patches/Updates April 26, 2017 • 0 Comments Q: I have a question about Windows 10 validation. In your FDA Auditing of Computerized Systems and Part 11 /Annex 11 class, you pointed out that the “environment” for software/hardware is important when it comes to validation, because a different environment…
Part 11 Password Safeguards: What’s Really Required? May 17, 2016 • 0 Comments Q: My question concerns the requirement for Part 11 password safeguards (Part 11.300(d)) that prevent unauthorized use of passwords or identification codes. We’ve always considered the “detect and report” portion of this requirement to include logging unsuccessful attempts and then reviewing those…
Test Results: Better to Type or Hand-Write? March 1, 2016 • 0 Comments Q: We have some testers who prefer to type their test results; others like to hand-write their results. Is there a rule of thumb for how best to record test results? Must they be handwritten? Or can the testers type…
Will the FDA Accept Electronic Versions of Paper Documents? February 17, 2016 • 0 Comments Q: In the case where an original record was paper-based (with signatures, etc.), will the FDA accept an electronic representation of that paper document? Some of our documents have wet ink signatures that we scan and then retain the electronic record while…
Does Authentication Count as the First Electronic Signature? July 30, 2015 • 0 Comments Q: Access to our computer system is controlled via two distinct components: username and password. After a user first accesses the system, subsequent electronic signatures ask for a reason for the signing and require a password. In your opinion, does the…
Single Sign-On System (SSO): Pros and Cons in GxP Environments July 14, 2015 • 0 Comments Q: To make life less complicated for our end-users, we’re considering implementing a Single Sign-On System (SSO) in our GxP environment. Under the system, a Windows user name and password is required only at workstation log-in. Once the user logs…
Should Contract Manufacturers Who Use Electronic Signatures Notify FDA? June 22, 2015 • 0 Comments Q: I’m contacting you to get advice on a possible issue regarding electronic signatures encountered during an audit of one of our contract manufacturers. The contract manufacturer in question manufactures and releases implantable medical devices for our company. We hold the…
FAQs about EduQuest FDA Compliance Training Classes April 8, 2015 • 0 Comments What makes EduQuest’s FDA compliance training better than others? Experience and our ability to let you “peek behind FDA’s curtain”. Each course is taught by full-time, senior-level EduQuest staff with more than 20 years’ experience on both sides of the…
Part 11 Cheat-Sheet: What Does Part 11 Really Cover? April 2, 2015 • 0 Comments In proportion to their relatively short length, 21 CFR Part 11 and FDA’s Part 11 Scope and Application guidance generate a huge amount of confusion and questions from EduQuest’s clients. So we’ve developed the following Part 11 cheat-sheet to help you better understand compliance. When in…