AI-Enabled Platformsfor Continuous Readiness and Decision Support
PIOL software products are built to reduce manual compliance effort, improve signal detection, and keep evidence, governance, and execution connected—continuously.
Regulatory intelligence you can act on.
Who It's For: Quality and Regulatory leaders and practitioners in Drugs, Life Sciences, Food and Medical Devices who need early warning and defensible, citation-backed insight from FDA signals—so decisions accelerate, risk becomes visible sooner, and responses are regulator-ready.
Delivers: Unified FDA product + enforcement intelligence with trend visibility, peer benchmarking, and audit-ready outputs supported by citations and end-to-end traceability.
Key Capabilities:
- Signal monitoring & detection: inspections, CFR citations, Form 483s, Warning Letters, recalls, adverse events, compliance actions, import refusals
- Risk themes & peer benchmarking: identify systemic patterns, compare exposure by product/site/peer set, and prioritize action
- AI-assisted Quality outputs: SOP/WI drafting and CAPA structure aligned to observed regulatory concerns and enforcement patterns
- Executive-ready reporting: generated briefs and white papers with citations, source lineage, and traceable claims
Data Coverage:
- FDA Enforcement & Compliance Data: Inspections, CFR Citations, Form 483s, Recalls, Adverse Events, Compliance Actions, Import Refusals
- FDA Product Data: Device Classifications, 510(k) Clearances, PMA Approvals, Device Registrations, Drug NDC, Drug Applications
Quality Tools (in-platform):
Inspection Readiness • Peer Benchmarking • CAPA Generator • SOP/WI Generator • Citation-Backed White Papers
Certification implementation without the scramble.
Who It's For: Teams deploying and sustaining management systems across ISO/IEC and scheme-based standards—especially multi-site organizations that need global standardization with justified local variation, continuous surveillance readiness, and controlled transitions when standards update.
Delivers: End-to-end deployment guidance, requirements-to-evidence traceability, evidence freshness/ownership controls, readiness scoring, and audit-ready outputs that hold up to internal governance routines and third-party scrutiny.
Key Capabilities:
- 20+ Standard Certification Paths: gap assessment, implementation roadmap, Stage 1/Stage 2 readiness gates, surveillance planning
- Multi-Standard Workflows: integrated implementation across QMS/EMS/OHS/ISMS/FSMS/BCMS and schemes
- Evidence Freshness & Ownership: assignment, validation, aging alerts, and audit-proof evidence libraries
- Audit Execution & Closure: internal audit programs, findings/CAPA workflows, management review cadence
- Continuous Readiness Scoring: site-level and enterprise rollups with trend visibility
- Standards Change Management: update tracking, impact assessments, transition plans, version-to-version controls