ProofOS is the AI Evidence & Inspection Readiness Platform built for Life Sciences. It turns scattered clinical, quality, SOP, TMF, CAPA, deviation, and audit records into source-linked evidence, AI-detected gaps, remediation workflows, and audit-ready proof packs — so your studies are always inspection-ready, not just when an audit is announced.
Life Sciences organizations generate enormous volumes of clinical, quality, and compliance evidence — but when an inspector arrives, teams scramble for days to locate, compile, and present it coherently.
Clinical records, SOPs, TMF documents, CAPA logs, deviation files, and training records are scattered across different systems, folders, and departments — disconnected from each other.
Documentation gaps and missing evidence are typically discovered at audit time — not before. Teams learn about problems when an inspector identifies them, not proactively.
Study teams spend days or weeks gathering evidence in response to regulatory inspection notices — creating unnecessary stress, risk, and operational disruption for every audit cycle.
SOPs describe required processes — but proving that those processes were actually followed, with evidence, is a separate, labor-intensive task with no structured mechanism.
Trial Master File completeness reviews, document reconciliation, and gap identification are done manually — slowly — often without a systematic view of what is missing or incomplete.
Demonstrating that a CAPA or deviation was addressed requires assembling evidence from multiple sources — and verifying it is complete, source-linked, and ready for inspector review.
ProofOS connects, structures, proves, detects, and activates — turning fragmented Life Sciences records into a continuously maintained evidence intelligence layer.
Connect clinical records, SOPs, TMF documents, CAPA files, deviations, training records, and audit correspondence from multiple systems and formats.
Build a domain-aware evidence model that maps how documents, processes, responsibilities, and study activities relate to regulatory requirements and inspection domains.
Generate source-linked evidence responses to inspection questions, SOP compliance queries, and TMF completeness checks — with every claim traceable to a specific document and location.
Continuously surface documentation gaps, missing evidence links, incomplete TMF sections, and CAPA closure gaps — before an inspector identifies them.
Trigger remediation workflows, assign gap resolution tasks, generate inspection response drafts, and create audit-ready proof packs — structured for human review and approval.
ProofOS maintains a continuously updated evidence layer across your study portfolio — so when a regulatory inspection is announced, you are not starting from scratch. Evidence is already structured, source-linked, and gap-identified.
ProofOS brings structure and intelligence to Trial Master File reviews — identifying missing documents, incomplete sections, and evidence gaps within the TMF — continuously, not just at study close.
SOPs define what must be done — but proving that specific processes were followed requires connecting the SOP to actual operational evidence. ProofOS automates this evidence-to-SOP mapping with source-linked traceability.
Closing a CAPA or deviation requires complete, verifiable evidence that the corrective action was implemented effectively. ProofOS structures and validates CAPA closure evidence — making it defensible under inspector review.
Sponsor audits, regulatory inspection preparation, TMF handover readiness, and multi-study QA evidence management — all on compressed timelines.
Vendor oversight evidence, regulatory authority submission support, inspection readiness programs, and clinical quality management at scale across studies and geographies.
High-frequency inspections, dense SOP requirements, volunteer study documentation, protocol deviation evidence, and audit-ready study file management for bioequivalence environments.
Continuous inspection readiness programs, internal audit response preparation, GCP compliance evidence retrieval, and cross-study quality system intelligence.
eTMF completeness monitoring, trial master file gap identification, document relationship mapping, and inspection-ready TMF preparation at study close and beyond.
Vendor audit evidence management, CRO oversight documentation, GCP monitoring evidence, and enterprise-level quality system intelligence across the development portfolio.
ProofOS generates structured, human-reviewable outputs — not uncontrolled AI answers. Every output is designed for qualified expert review before use in regulated contexts.
Controlled evidence bundles mapped to specific inspection questions or audit domains — with source document links, evidence summaries, and human-reviewed response drafts.
Structured gap analysis reports identifying missing evidence, incomplete documentation, and unlinked records — by domain, study, or regulatory requirement — for proactive remediation.
Visual and structured representation of TMF completeness status against the reference model — with missing document flags, responsible parties, and remediation priority ranking.
Structured mapping of SOP requirements to operational evidence — showing which process steps have traceable evidence and which require additional documentation for inspection readiness.
Organized evidence bundles demonstrating CAPA implementation, effectiveness, and closure — structured for QA review and regulatory inspector verification.
Continuously updated readiness views across studies, domains, and evidence categories — showing the current state of inspection preparedness with actionable next steps.
| Capability | Document Management System | Generic AI Chatbot | ProofOS |
|---|---|---|---|
| Evidence Gap Detection | ❌ Manual review only | ❌ No structured gap analysis | ✅ Continuous, AI-driven gap detection |
| Source-Linked Answers | ⚠️ Locates documents only | ❌ Probabilistic, not traceable | ✅ Every answer linked to source document |
| TMF Completeness Intelligence | ⚠️ Storage only; manual QC needed | ❌ Not designed for TMF context | ✅ Structured TMF zone mapping & gap reports |
| SOP–Evidence Linking | ❌ Not supported | ❌ No regulatory domain context | ✅ Automated SOP-to-evidence mapping |
| Inspection Response Generation | ❌ Not supported | ⚠️ Generic text, not source-grounded | ✅ Structured proof packs for human review |
| Life Sciences Domain Context | ⚠️ Generic document taxonomy | ❌ No regulatory AI alignment | ✅ Built for GCP, ICH, 21 CFR Part 11 contexts |
| Human Review Workflow | ⚠️ Basic approval workflows | ❌ No structured review process | ✅ Mandatory QA expert review before output use |
| Audit Trail for AI Actions | ⚠️ Document access logs only | ❌ No audit trail | ✅ Full trail for evidence retrieval & review |
ProofOS is not a generic AI tool applied to compliance. It is designed from the ground up with the evidence, traceability, and human accountability requirements of GCP-regulated environments.
Every ProofOS evidence response retrieves from your organization's own documents — not from model weights or external sources. Evidence claims link to specific documents, sections, and page references.
AI detects gaps and generates evidence drafts. Qualified QA, regulatory, and clinical professionals review, validate, and approve all outputs before they are used in any inspection, audit, or submission context.
Complete, timestamped records of what evidence was retrieved, who reviewed it, what was changed, and who approved — creating the accountability trail needed for regulated AI use in inspection contexts.
Access to evidence, gaps, and proof packs is controlled by user role — ensuring the right professionals see the right evidence at the right stage, with appropriate review and approval permissions.
ProofOS is designed to support customer validation documentation and controlled implementation practices. WHPL can provide implementation records, configuration documentation, and validation support as applicable.
ProofOS is designed to support — not guarantee — compliance outcomes. Regulatory compliance depends on customer processes, validation practices, and qualified human oversight. ProofOS provides tools; your team provides accountability.
ProofOS is being developed as a continuously expanding inspection readiness intelligence platform. The following capabilities are on the development roadmap and are subject to change.
Real-time inspection readiness scoring connected to active study operations — identifying evidence gaps as they emerge, not at study close.
Enterprise-level inspection readiness view across the full study portfolio — identifying systemic gaps, cross-study patterns, and portfolio-level quality risks.
Automated task assignment and tracking for gap remediation — connecting detected evidence gaps to responsible parties with structured resolution workflows.
Features described as roadmap items are indicative of development direction and are not commitments to delivery timelines or specific functionality.
Request a ProofOS demo showing inspection readiness evidence mapping, TMF gap detection, SOP-evidence linking, or CAPA closure evidence packaging — for your specific study type and quality context.