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
Generate 8D/CAPA documentation with root cause analysis, containment actions, corrective actions, and effectiveness verification plans.
by exact.works
Cost of quality analysis including prevention, appraisal, internal failure, and external failure costs with improvement recommendations.
by exact.works
Calibration compliance review, measurement system inventory, recall status verification, and calibration schedule optimization.
by exact.works
Analyze defect data for root cause patterns, Pareto analysis, trend identification, and corrective action effectiveness tracking.
by exact.works
Supplier quality audit preparation, capability assessment, and supplier development recommendations based on quality performance metrics.
by exact.works
Generate Design FMEA and Process FMEA documents with risk priority number calculations, recommended actions, and AIAG-VDA alignment.
by exact.works
Analyze change control records for compliance, impact assessment completeness, and regulatory notification requirements.
by exact.works
Assess laboratory data integrity against ALCOA+ principles with gap analysis and remediation recommendations.
by exact.works
Review batch production records for GMP compliance, data integrity, and completeness with deviation flagging.
by exact.works
Document and analyze Corrective and Preventive Actions including root cause analysis, effectiveness criteria, and trending reports.
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
Audit construction QA/QC documentation including inspection reports, test results, and corrective actions.