Instrument Template Checklists for V&V / IQ, OQ, PQ
A given machine has a standard set of functions
A given machine has an intended set of functions.
The above line is the substance behind this. While not exhaustive I’d dare to say:
(programmer speak)
A standard set of “Installation Qualifications” can reliably be attached to a given instrument, as well as all instances of that instruments across that class of instruments.
“Operational Qualifications”, ditto. “Performance Qualifications” will naturally be tailored more to the specifics of the bandwidth limits of the process.
AGAIN. This is not intended to be exhaustive or sufficient for full regulatory clearance, but instead the intention is to give examples of what these tests should look like, to inform / educate and ‘give a foothold’ to engineers bridging into validated processes.
Again.
A given machine has an intended set of functions.
“Flow Cytometer” will separate out cells of different tags or lineages.
“High Pressure Liquid Chromatograph“ separates out proteins from messy solutions.
“Centrifuges” separate out different densities of materials.
“Mass Spectrometers” identifies different compounds within a sample by charge/mol weight.
(I may or may not expand this list later for keyword matching)
Now, setting aside for a moment the edge-case of aftermarket modified instruments (yes this happens and yes its awesome) we have a somewhat tractable problem for Validation & Verification.
A given instrument is intended to perform a small subset of tasks as it pertains to a given product’s manufacturing process.
Brilliant.
Having sensible boilerplate checklists for any of these instruments seems like something which could save all of industry a bunch of time.
From my research, we have no such standard checklists.
Lets change this — even if its simple, boilerplate stuff like
Installation Qualifications:
The machine is stable and does not tilt, rock or move in its physical placement.
The machine turns on.
The machine can intake a sample of a single or multiple physical formats.
The machine has an external label with a list of users trained on its operation.
Should be powered with a grounded plug.
Power supply should be of sufficient power for the machine.
Access to all sides of the machine should be obstruction-free, to facilitate cleaning.
Supply lines for compressed air, deionized water, Nitrogen, Argon etc should be connected.
A properly pressurized room if positive pressure installation is called for.
Machine is properly labeled with its Model designation and Serial number.
Appropriate exhaust connections for the machine.
Operational Qualifications:
The machine can reliably intake a calibrated sample.
The output data is in Z format.
The output data can be parsed by software integration test K for proper internal data format.
The machine has a label of its calibration / maintenance schedule.
Performance Qualifications:
The machine reliably quantifies a calibrated sample.
These will be slightly more specific to each machine as this is the core function so well table this for another time.
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