Prints a formatted summary of a regulatory submission profile including authority details, pillar weights, decision bands, and requirements.
Examples
prof <- submission_profile("FDA", "NDA")
profile_summary(prof)
#> ℹ Submission Profile: FDA NDA
#> Authority: U.S. Food and Drug Administration (United States)
#>
#> Pillar Weights:
#> quality 0.35
#> trace 0.25
#> risk 0.25
#> usability 0.15
#>
#> Decision Bands:
#> ready [85, 100]
#> minor_gaps [70, 84]
#> conditional [50, 69]
#> high_risk [0, 49]
#>
#> Required Indicators (15):
#> - Q-MISS-VAR
#> - Q-TYPE-MISMATCH
#> - Q-LABEL-LEN
#> - Q-DUP-RECORDS
#> - Q-FORMAT-ERR
#> - T-ORPHAN-VAR
#> - T-TRACE-LEVEL
#> - T-AMBIGUOUS-MAP
#> - T-DERIVATION-DOC
#> - R-HIGH-RPN
#> - R-OPEN-RISK
#> - R-MITIGATION-GAP
#> - U-DEFINE-COMPLETE
#> - U-REVIEWER-NOTE
#> - U-LABEL-QUALITY
#>
#> Required Asset Types: dataset, define, program, validation, spec
#> Minimum Coverage: 90%
#> Default Detectability: 3