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
Cold chain compliance review analyzing temperature monitoring, documentation, and regulatory requirements for temperature-sensitive shipments.
by exact.works
Generate product lifecycle documentation including Annual Product Reviews, product quality reviews, and trend analysis.
by exact.works
Monitor regulatory changes across FDA, EMA, and ICH with impact analysis and implementation timeline tracking.
by exact.works
Review cleaning validation documentation including residue limits, sampling strategies, and analytical method suitability.
by exact.works
Analyze change control records for compliance, impact assessment completeness, and regulatory notification requirements.
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
Assess laboratory data integrity against ALCOA+ principles with gap analysis and remediation recommendations.
by exact.works
Generate IQ/OQ/PQ documentation for pharmaceutical manufacturing equipment with test protocols and acceptance criteria.
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
Generate regulatory safety reports including CIOMS forms, MedWatch reports, and periodic safety update reports.
by exact.works
Analyze bioequivalence study data including statistical analysis, confidence interval calculations, and BE criteria assessment.