Result oriented? Analyst driven? [Regulatives / Guidelines]

posted by ElMaestro  – Denmark, 2015-08-10 12:53 (3474 d 19:17 ago) – Posting: # 15210
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Hi Mr. Rao,

now you sound like a banker or a LEAN consultant :-D
I don't know how those terms fit into the realm of regulated BE.

Why would a bioanalyst have access to the rand. code after all? I think there should be a reason; preferably a better reason than just convenience. Of course, from a regulatory side there might arise a bit of fear that knowledge pf the rand. code could be used inappropriately somehow: As far as I can tell a bioanalyst knowing the rand. code can use that knowledge inappropriately during the analysis phase (without going into detail, mind you), and coversely I don't see how the knowledge can be used in a good fashion. If you ever find yourself in a situation where people question the integrity of a study then you are better off if you can demonstrate that the QMS is mature and that the rand. code is not accessible or accessed until the day of stats.

Pass or fail!
ElMaestro

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