PLR in regulated labs

Hi all! :slightly_smiling_face:

I’m currently in the process of organizing a PLR workshop in Denmark with Rick and Camillo, and have come to realize that one of the major roadblocks for getting people engaged in PLR, is the uncertainty of whether a laboratory workflow built on PLR can be validated in a regulated environment (GxP/GAMP5/21 cfr part…).

I’ve been in contact with a compliance specialist who said that it should be possible, BUT the lab seeking validation will have to “own” the entire codebase due to the open source nature including all python dependables that PLR rely on etc.

I’m curious to hear if someone in this forum already have experience with going down that road with PLR, and what the learnings were? :slightly_smiling_face:

Best, Kim

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This is a major moat Hamilton and all device manufactures have and why they haven’t been afraid of these endeavors before.

You would probably have to freeze a version and pay to validate. I think its too early for this. Possibly this could be crowd funded in the future idk

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