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ADAM QC plays important role to validate the ADAM report with respect to ADAM implementation guide, because traceability is major concern for regulatory authorities.

ADAM qc having following documents

a). SAP—– master specification report

b). Pinnacle 21 to check the CDISC compliance

c). Define file-it contains the supporting documents and link within document/computational algorithm, comment and controlled terminology

d). Using standardized macro which are also generate report

e). Checking compliance with ADAM implementation guide

f) ADAM QC save the time for TLF generation also chance for minimum comments from regulatory authorities.

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