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Qualified File Storage - Computer System Validation

Discussion in 'Qualification & Validation (Also 21 CFR Part 11)' started by Rick Is, Apr 15, 2022.

  1. Rick Is

    Rick Is New Member

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    Hi, I’ve been doing CSV for almost 20 years. Working on a new project where some coworkers are asking about qualifying storage space - for example, some manufacturing systems dump batch files to a space on a NAS. They’re asking about qualifying that storage location, and I’m not familiar with that practice. The only thing I can think to do is document / control how updates are performed (via change control) and verify periodically limited access to the storage.

    Has anyone qualified simple storage space? If so, what did you do? Do you have an example? Thanks!
     
  2. yodon

    yodon Well-Known Member

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    Hmm... interesting. Also never been confronted with that. Just brainstorming... Maybe physical access ? Maybe programmatic access (hacker access prevention)? I would think the software application would be responsible for any encryption (at rest) so that's probably out of scope. Maybe backup and recovery (if not addressed as part of the CSV work)? Capacity? (Geographic) Redundancy? Really digging but reliability (maybe not a concern if good backup / redundancy).
     
  3. Rick Is

    Rick Is New Member

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    Thanks for the ideas. Most of that is either tested out in the qualification of the file serving NAS or as part of the CSV of the application or addressed as part of data center planning. Great ideas though. Hoping that someone who has run into this question can shed some light or tell me it's non-value added and move on :)

    Keep the ideas coming! Thank you!
     
  4. BradM

    BradM Moderator Staff Member

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    Hello there!!

    I have never heard of such a practice either. And frankly... I really can't see how that would be a qualified parameter. I mean... what does it really matter whether you have 20 gig of storage or 40 gig? Not to mention, it will change constantly (probably an insignificant level...) each time something is saved or added.

    I could see that a particular application requires a minimal amount of storage. Most of the time folks either spec out the hard drive, or take a screenshot of the directory showing the storage size.