Trust Center
This page describes how the platform itself is governed. Looking for the quality module for SOPs and deviations? See Compliance Intelligence.
What the product does. What demonstrations establish. What still needs qualification. These are different questions — and deserve different answers.
Pharma Intelligence is not presented as FDA approved, formally GxP validated or certified under 21 CFR Part 11, ICH E6(R3), SOC 2 or ISO 27001. No confidential report, financial estimate or private clinical evidence is distributed through this page.
Authenticated operational records remain private. Clinical reviewer access requires accepted membership and an explicit study assignment. Revocation and cross-user isolation have been tested in bounded demonstration flows.
This is not an independent security audit or a guarantee against all threats.
Clinical files retain earlier versions and protected workflow events. Registered size, format and SHA-256 are checked for clinical downloads and AI inputs.
Integrity checking is not malware scanning. Complete registry/download traceability and audited orphan reconciliation remain operational gates.
System inventories, validation lifecycle stages, risk fields, incident relationships and reviewed impact assessments support validation-related work.
The existence of these functions does not establish formal validation of the platform for a specific regulated operational use.
Study/centre management, private versioned documents, a configurable basic completeness matrix, independent review, CSV reports and human-confirmed AI assistance have been exercised with fictional data.
The complete official TMF Reference Model taxonomy and ICH E6(R3) mapping are not claimed. Formal GxP use and regulatory certification are not established.
Clinical AI requires explicit owner consent for an eligible Draft file. Suggestions are version-bound and source-labelled; human confirmation is required before metadata is changed.
AI output is not authoritative evidence or an approval. Personal-data screening is not guaranteed, and the public demo never calls live AI.
Production requirements must be assessed separately: privacy governance, malware screening, independent backup/restore verification, larger-scale testing and intended-use validation.
No universal SLA, uptime, ROI, deployment geography, certified compliance or enterprise-scale capacity is promised here.
Use the commercial contact form to describe your review requirements. A request is not an agreement to release confidential material or a promise that any particular evidence exists.
Request an evidence discussionPublic disclosures reviewed 24 October 2026.
From complexity to context
Discuss your document, quality and clinical operations priorities.