Electronic Records

Change Control for Software Updates

Q: We’re performing a Medra library update to our drug safety software and also considering changing a specification in our LIMS static data. In a regulated environment, do these functions require change control, or do you consider them merely maintenance issues?…

Share

Best Practices for Part 11 Audit Trails

Do you understand FDA’s expectations for Part 11 audit trails? EduQuest’s staff experts have conducted literally thousands of site inspections around the globe. Here’s a quick self-check from our Compliance Toolkit to ensure you’re using the best practices for your audit trails. Are your…

Share

FDA Requirements for Source Data

Q: I’m trying to locate the source of the regulatory requirements to 1) maintain original source data as part of the official record and 2) maintain each copy of an executed qualification/validation protocol. Can you point me in the right direction?…

Share