Audit Archives - Particle Technology Labs

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Labs laid out well

Labs are laid out really well; you have a lot of equipment but you also have a lot of bench space.

Compliance with Part 11

Strong software / instrument / process validation program; obviously in compliance with Part 11.

Very clean lab

Obviously very clean…you can tell just by looking at [the lab] there’s a high attention to detail in maintaining the instruments.

Good process of OOS

You guys have a really good process for documenting and investigating OOS.

OSHA compliant

Lab and chemical hygiene compliant with OSHA. You get triple stars for that one.

Well-defined procedures

Procedures are all well–defined, well–written, clear, and all systems are covered and thorough.

Plenty of space, well-organized

Plenty of space…seems to be well organized…doesn’t look like our QC lab where people are literally on top of each other trying to do work.

Great place to audit

You guys are a great place to audit. I’m having the strangest good time auditing you.

Safety stuff

I could write a whole report on the safety stuff. I’m that impressed.

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Physical Measurement

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Pore Size

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Quality Assurance and Methods Compliance

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