Q: I have a question about generic logins. We’re getting computers on our production floor. Some colleagues have suggested we allow one generic login for all production personnel to view and print SOPs (with a watermark) and also to print the…
Tag Archive for Passwords
Part 11 Password Safeguards: What’s Really Required?
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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…
Does Authentication Count as the First Electronic Signature?
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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…
What FDA Inspectors are Trained to Look For…
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To effectively prepare for a visit from FDA, you must learn to look at your operations through the eyes of an FDA inspector. For your computerized systems, some items FDA inspectors and investigators are trained to observe include: – Is…
Electronic Signature: Does User Authentication Count as the First One?
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Q: I have a question about FDA’s expectations for an electronic signature. 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…
Electronic Signatures: When to Notify the FDA
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Q: Does my company need FDA approval to start using electronic signatures? A: No, but you do need to notify FDA of your intentions. Under 21 CFR Part 11.100 (c), you must certify to FDA that your personnel understand that their electronic…
Managing User Rights in Quality Systems: Best Practices
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Q: In a previous issue of EduQuest-ions & Answers, you discussed how some users prefer hard copy backups. That triggered questions in my mind about managing user rights in software used for CAPA, complaint handling, managing quality data (such as in…
Electronic Records for Training Evidence…When to Use Them and When Not to
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Q: If an audit trail module for a training software package doesn’t track adding or deleting an attachment (such as an attendance sheet) to a course, a company should not use electronic records for training evidence…correct? I’m assuming in this scenario a…
Is FDA OK with General or Shared Passwords?
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Q: I’m reviewing our policy on shared passwords and accounts. We’ve issued a limited number of general passwords to supervisors or operators on the production floor so they can retrieve production documents electronically. Under 21 CFR Part 11.300(a), is it…
Single Sign-On Systems Increase Risks of Part 11 Non-Compliance
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Q: You discussed the pros and cons of Single Sign-On Systems (SSOs) in an earlier issue of EduQuest-ions & Answers. Could you expand on your answer about the risks single sign-on systems represent in creating effective audit trails in a Part 11…