6 Comments

  1. Hi Saket

    Is it a requirement documented that the calibration ranges used must meet or exceed process ranges. That you cannot use a linearity statement if the calibration range is inside the process range?

    1. Either way, calibration requirements should meet the calibration outcomes.

  2. Hello Saket,

    Why the guidelines mention performance qualification for sterile only while non-sterile mentioned as process validation?

    1. Thanks, Rasha for reaching out.

      First thing first. Which guidelines you are talking about? Can you please provide reference? So that I can respond more meaningfully and actually could help you out.

  3. Hello Saket,

    Could you please help me with this?

    Ring central is voip used for calls at our company. It’s used for calls over wifi including adverse events reporting. Should this be considered as infrastructure and qualified or validated as a system.

    1. Hi Sudhakar, voice over IP is a communication tool and comes as a Category 1 I guess.
      According to ISPE data integrity experts, since GAMP 5 category 1 software does not store or create data, it can be managed using good IT practices and routine assessments. As a result, category 1 solutions don’t need validation, only qualification. This does not mean that life sciences companies should not take steps to ensure the security of their software and infrastructure.

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