149 lines
4.3 KiB
YAML
149 lines
4.3 KiB
YAML
version: 1
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defaults:
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method: mckinsey_market
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methods:
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mckinsey_market:
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name: McKinsey-style market and strategy research
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best_for:
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- market research
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- investment memo
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- competitive landscape
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structure_principle: Pyramid principle with MECE chapter coverage.
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task_axes:
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- literature
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- regulatory
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- patents
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- market
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- counter
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integrated_lanes:
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- literature evidence
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- regulatory pathway
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- patent/IP position
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- market and competitor evidence
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- counter-evidence and uncertainty
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framework_sections:
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- central_thesis
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- chapter_outline
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- alternative_frameworks
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- risks_and_dependencies
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gmp_gap_assessment:
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name: GMP consulting gap assessment and remediation
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best_for:
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- GMP audit remediation
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- quality system consulting
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- supplier audit CAPA
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structure_principle: Regulation-to-gap-to-risk-to-CAPA pathway.
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task_axes:
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- regulatory_gap
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- risk_classification
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- capa_design
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- ownership_timeline
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- verification_evidence
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- counter
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framework_sections:
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- regulatory_baseline
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- gap_matrix
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- risk_ranking
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- capa_roadmap
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- verification_plan
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cmc_process_risk:
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name: CMC process and scale-up risk assessment
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best_for:
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- process development
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- tech transfer
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- manufacturing readiness
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structure_principle: Process-flow, CQA/CPP, scale-up, control strategy.
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task_axes:
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- process_flow
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- cqa_cpp
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- scale_up_risk
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- control_strategy
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- supply_chain
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- counter
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framework_sections:
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- process_map
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- critical_quality_attributes
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- critical_process_parameters
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- scale_up_risks
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- control_strategy
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rd_go_no_go:
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name: R&D go/no-go decision research
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best_for:
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- project initiation
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- modality selection
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- development strategy
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structure_principle: Scientific rationale, proof-of-concept, IP/FTO, development path, go/no-go criteria.
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task_axes:
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- scientific_rationale
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- poc_evidence
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- ip_fto
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- development_path
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- commercial_window
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- counter
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framework_sections:
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- scientific_rationale
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- evidence_threshold
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- ip_fto
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- development_plan
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- go_no_go_criteria
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management_consulting:
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name: Management consulting diagnostic and operating model
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best_for:
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- organization diagnosis
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- operating model design
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- governance and process improvement
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structure_principle: Diagnostic baseline, capability gaps, operating model, roadmap, governance.
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task_axes:
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- current_state
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- capability_gap
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- operating_model
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- governance
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- implementation_roadmap
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- counter
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framework_sections:
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- current_state_diagnosis
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- capability_gap
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- future_state_model
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- roadmap
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- governance_metrics
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gmp_quality_operations_diagnosis:
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name: GMP quality, manufacturing process, and operations diagnosis
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best_for:
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- GMP audit remediation from client materials
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- quality system diagnosis
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- manufacturing process system diagnosis
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- operations management transformation
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structure_principle: Start from site audit evidence, map findings to regulatory baseline and operating model gaps, then design short/mid/long-term remediation.
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task_axes:
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- input_material_findings
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- nmpa_fda_ema_ich_who_baseline
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- quality_system_gap
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- manufacturing_process_risk
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- operations_management_gap
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- team_capability
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- capa_roadmap
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- verification_evidence
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- counter
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integrated_lanes:
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- site audit and recap findings
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- official regulatory and guideline baseline
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- enforcement precedents and warning letters
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- quality/manufacturing/operations gap analysis
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- remediation actions, ownership, verification evidence
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- counter-evidence and boundary conditions
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framework_sections:
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- material_evidence_map
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- regulatory_and_best_practice_baseline
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- quality_system_gap_matrix
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- manufacturing_process_risk_map
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- operations_management_diagnosis
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- people_and_capability_diagnosis
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- short_mid_long_term_roadmap
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- governance_and_verification_plan
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