Hello good people of the world! Today’s post is a short one covering things you should check before starting a Computer Systems Validation (CSV) package execution so you can hit the ground running! This list assumes you have an approved protocol, of course. 🙂
- Is the specification approved? You also want to ensure there is no in-progress revision that might effect your validation.
- Is the hardware installed? Ideally you’d have some formal commissioning that has already done this, but if not it’s good to make sure.
- Is the software installed. Same as above, but for software.
- Programming is complete. Make sure there is no in-progress changes that could effect your validation.
- Is the equipment available? Find out from the system owner and make sure they know how much time you’ll be on the system and what potential impacts to other systems there could be (e.g. interlocks to external systems).
- Are test accounts setup and available. Make sure you have test accounts for the testing you’ll be doing, and/or a procedure for adding/removing test accounts.
- Are resources available? If you need support from controls/automation engineers, IT staff, anyone else make sure they’re aware and available before you need them.
- Make sure all stakeholders are aware: automation, system owner, QA. QA needs to know if deviations might be coming their way.
Additionally I like to send a daily update of accomplishments and issues discovered to all stakeholders during an execution. It’s hard to communicate too much!
What items do you think about before starting your CSV executions?
Like this MWV (Mike Williamson Validation) blog post? Be sure to like, share, and subscribe!
Mike Williamson Validation 