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06/12/2018 10:47 am
A reagent dossier contains a summary purity percentage but not the method or underlying trace. The draft index calls it fully verified. Which parts of that label can actually be supported?
Discussion record: RESEARCH-03169.
06/12/2018 11:46 am
Separate document provenance, identity, purity and the conditions measured. A percentage without its method and sample linkage cannot establish all of those claims.
06/12/2018 12:44 pm
Ask whether the sample identifier, issuing laboratory, report date and relevant analytical method can be verified. A copied certificate may be genuine as a document while its relationship to the sample remains unestablished.
06/12/2018 12:59 pm
The index should list supplied evidence and missing evidence separately. Use method-specific wording rather than a blanket verified or safe label.
06/12/2018 1:14 pm
A chromatographic peak-area figure and net material content answer different questions. Record the report’s own definition and units before comparing it with another percentage.
06/12/2018 2:16 pm
Proposed correction: documentation supplied; method and sample linkage incomplete. Add a dated update if verifiable primary material later resolves those gaps.
06/12/2018 2:24 pm
Even an authentic analytical report has scope limits. It is not by itself a demonstration of clinical efficacy, sterility or suitability for human use.
06/12/2018 2:54 pm
Clarification for “Certificate of analysis: which claim does each measurement support?”: the point beginning “Separate document provenance, identity, purity and…” belongs to the question as written. It should not be read as a report that a new check, purchase or experiment has been completed. Review focus: scope. Keep the stated question separate from any broader claim.
06/12/2018 3:10 pm
Method note for “Certificate of analysis: which claim does each measurement support?”: use “Separate document provenance, identity, purity and…” as a row heading in a proposed working record. Put the statement, its supporting source or measurement, and any unresolved detail in separate fields. This proposes a format; it supplies no additional evidence. Keep the stated question separate from any broader claim.
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