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Thread: Planned LIMS downtime

  1. #1
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    Planned LIMS downtime

    We are due to have a short planned downtime for our LIMS (1 hour) and I'm interested to see how other people would document this. I have a Business continuity SOP that we will follow and a risk assesment for short term downtime on the LIMS. The downtime will be before the bulk of daytime testing and it's entirly possible that it would have no effect on our work (we are a small DGH). Would you write a down time report to document any issues or just that it had all gone as planned or only raise a non-conformace if there were any issues?

    Also if the downtime was not going to change anything in the LIMS would you still do some validation?


  2. #2
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    Hi CarlyL
    I would raise a QI for recording the reason for the downtime and to ensure reconciliation of any units issued via your downtime process . If you have knowledge of your LIMS and that similar reasons for downtime haven't impacted on critical functions, including interfaces, that's fine, but some simple validation/ checks such as compatibility rules, printing, interfaces would be wise. Your IT manager should have documented this and given some guidance.

    Dare I say the dreaded words of Change Control ........

  3. #3
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    The downtime was to allow a copy of the system to be made in advance of a hardware upgrade in IT (when this happens there will be a full validation). In this instance no changes were made it's just that the system was unavailable while they did the prep work. Everything went as planned and there were no effects on the work or how the LIMS functioned. IT have done their own change control for the hardware upgrade overall but as no actual changes were made during the down time, so would you still validate?

  4. #4
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    No, I don’t think I would validate- as long as you have this all recoded.
    bw

  5. #5
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    Hi

    I would agree with Rashmi regarding raising a QI however if their is no effect on your business process and your BCP works and the downtime goes to plan then it could be argued that their would be no requirement to log it as a planned LIMS downtime is an opportunity to exercise your BCP which should be part of a sites self inspection programme. Its then only a case of logging the failures that you experience as QI's.

    If a site knows what has changed and how this change may or may not affect their business processes then the decision to re validate is up to the site based on the impact and risk assessment of the planned changes. If it is deemed to be minimal then it may be prudent to carry out a mini validation such as running through a sample from testing to issuing and fating a blood component. Sites will need to assure themselves that just because another department says that their wont be any changes that this is truly the case to avoid any unexpected surprises.

    I hope this helps.

    Kind regards

    Mike

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