by exact.works
Real-time due diligence session. Upload target documents, conduct structured Q&A, receive a formatted memo with findings and flagged risks.
by exact.works
Three-agent pipeline that ingests multiple documents, cross-references them for conflicts and gaps, and produces a unified synthesis report with executive summary.
by exact.works
Accepts raw data and prepares structured regulatory filing drafts with required fields populated and human-review flags clearly marked.
by exact.works
Aerospace quality management system assessment against AS9100D/EN9100, including risk management, configuration management, and product safety compliance.
by exact.works
Monitor regulatory changes across FDA, EMA, and ICH with impact analysis and implementation timeline tracking.
by exact.works
Conduct quality risk assessments per ICH Q9 using FMEA, FTA, or HACCP methodologies with risk ranking and mitigation strategies.
by exact.works
Analyze environmental monitoring data for cleanroom compliance, trend identification, and excursion investigation support.
by exact.works
Document process validation lifecycle including process design, qualification protocols, and continued process verification.
by exact.works
Analyze ICH stability data including trending, shelf-life estimation, and out-of-specification investigation support.
by exact.works
Analyze adverse event databases for safety signals using statistical methods including PRR, ROR, and EBGM with trend visualization.
by exact.works
Comprehensive assessment of electronic records and electronic signatures compliance, gap analysis, and remediation roadmap for FDA 21 CFR Part 11 requirements.
by exact.works
Assess building envelope design and performance including air barriers, vapor retarders, and thermal performance.
by exact.works
Analyze contract bonding requirements and verify compliance with performance, payment, and bid bond obligations.
by exact.works
Track, categorize, and generate responses to RFIs with design clarification analysis.
by exact.works
Assess project design against LEED certification criteria and identify credit achievement opportunities.