by exact.works
Analyze adverse event databases for safety signals using statistical methods including PRR, ROR, and EBGM with trend visualization.
by exact.works
Prepare regulatory submission documents including eCTD modules, pre-submission meeting requests, and response to FDA queries in compliant format.
by exact.works
Develop comprehensive validation protocols for GxP computerized systems including IQ/OQ/PQ planning, risk assessment, and traceability matrices.
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
Audit procurement processes for compliance with public bidding requirements and DBE/MBE goals.
by exact.works
Audit construction documents and facilities for ADA and accessibility code compliance.
by exact.works
Track and verify construction submittals against specification requirements and approval status.
by exact.works
Analyze contract bonding requirements and verify compliance with performance, payment, and bid bond obligations.
by exact.works
Generate building commissioning documentation including Cx plans, functional test procedures, and issues logs.
by exact.works
Review construction documents against ICC building codes including IBC, IMC, IPC, and IECC.
by exact.works
Calculate retainage amounts, release schedules, and track compliance with contract retention terms.
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.