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
Material traceability system review, lot tracking verification, certificate of conformance validation, and chain of custody documentation.
by exact.works
Generate FAI documentation per AS9102 requirements, including Forms 1, 2, and 3 with characteristic accountability verification.
by exact.works
Calculate Overall Equipment Effectiveness from production data, identify six big losses, and benchmark against world-class standards.
by exact.works
Supplier quality audit preparation, capability assessment, and supplier development recommendations based on quality performance metrics.
by exact.works
SPC implementation review, control chart analysis, process capability assessment, and out-of-control action plan verification.
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.