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Taking into account the data model, those changes should be documented that modify identified business elements, i.e., create new ones, modify the existing ones, establish new dependencies, or alter the existing relationships.
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Change control should be documented and revalidation should be performed as necessary.
First, minimally important change (MIC) scores should be documented.
Changes that occur during a startup should be documented; changes fall into typical categories defined in this chapter.
However, in these cases, the changes to the study protocol should be documented in amendments of the original study protocol.
When using fluorescence spectroscopy and CD as indicators of polypeptide binding and conformational change, respectively, the effect of zwitterionic lipids only should be documented.
Any planned or actual changes from the original written protocol in the conduct should be documented with formal protocol amendments.
"Everything should be documented.
"His body has witnessed much and should be documented".
It should be documented, preserved and made accessible.
Validation/qualification activities should be documented.
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