Labs are laid out really well; you have a lot of equipment but you also have a lot of bench space.
Strong software / instrument / process validation program; obviously in compliance with Part 11.
Obviously very clean…you can tell just by looking at [the lab] there’s a high attention to detail in maintaining the instruments.
You guys have a really good process for documenting and investigating OOS.
Lab and chemical hygiene compliant with OSHA. You get triple stars for that one.
Procedures are all well–defined, well–written, clear, and all systems are covered and thorough.
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.
You guys are a great place to audit. I’m having the strangest good time auditing you.
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