Requirements ⇒ recommendations [BE/BA News]

posted by Obinoscopy  – USA, 2018-08-03 00:59 (2389 d 20:02 ago) – Posting: # 19129
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❝ Not surprising. I used an online tool. Requirement(s) in the version of May 21 changed to recommendation(s):


❝ VIII. Glossary, Batch

❝ old:

A batch is a number of unknown samples from one or more patients in a study and QCs that are processed at one time.


❝ new:

For purposes of this guidance, a batch is a number of unknown samples from one or more pati­ents in a study and QCs that are processed at one time.



Wow, thanks. Now I know the reason for the update. No more pondering. Mucho Gracias

Scopy

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