Tag Archive for Change Control

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?…

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Auditing Computer Systems: Some Quick Tips

Here are some quick tips for auditing computer systems. Choose a function within the system to audit. Select the function based on: A known point of risk; A known problem or defect; Complaints, break/fix records, system change records, data change…

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