GxP-aware AI governance for regulated research.
Pharmaceutical and life sciences companies face a unique AI governance challenge: the same tools accelerating research must produce evidence artifacts that satisfy FDA, EMA, and ICH expectations. 2Trust.AI bridges the gap between AI productivity and GxP compliance.
GxP environments weren't designed for AI — and regulators know it.
Validation requirements
21 CFR Part 11 and EU Annex 11 require that computerized systems used in regulated research be validated. Most AI tools aren't designed with GxP validation in mind — and using them in regulated workflows creates a qualification gap.
Controlled vocabulary enforcement
Research teams using AI to draft protocols, SOPs, or regulatory submissions may inadvertently introduce non-standard terminology. MedDRA, WHO-DD, and company-controlled vocabularies aren't enforced by commercial AI APIs.
IP and CCI exposure
Prompts containing compound names, trial designs, or unpublished study data sent to commercial AI APIs represent potential IP disclosure and competitive intelligence exposure — especially for pre-submission pipeline work.
Validated AI governance that produces evidence regulators accept.
GxP-aligned deployment
2Trust deployment packages include IQ/OQ/PQ documentation templates, change control procedures, and audit trail specifications aligned to 21 CFR Part 11 and EU Annex 11. Qualification evidence is a deliverable, not an afterthought.
Terminology enforcement
Load MedDRA, WHO-DD, or proprietary controlled vocabularies as dynamic disallowed and required-term lists. Screen prompts and responses for terminology compliance before documents enter regulatory workflows.
CCI and compound screening
Disallowed lists for compound codes, trial identifiers, and pre-submission data markers block confidential information from reaching external AI APIs. For sensitive pipeline work, route to in-VPC local models instead.
21 CFR Part 11 audit log
Every prompt, response, and policy change is logged with user identity, timestamp, and data hash. Audit trail is tamper-evident, exportable, and structured for inclusion in regulatory submission dossiers and site inspection readiness.
Protocol and SOP authoring
Ingest your approved protocol library, SOPs, and regulatory guidance documents into scoped DocumentCollections. AI-assisted drafting draws only from your approved corpus — reducing hallucination and terminology drift.
No data leaves your environment
Run 2Trust inside your validated cloud environment or on-premises. Pipeline data, compound structures, and trial designs never transit external infrastructure. Satisfies the data governance expectations of FDA and EMA for AI-assisted submissions.
Ready to make AI GxP-compliant?
We work with quality, regulatory affairs, and IT validation teams. Let's map your AI use cases to your GxP obligations and design a deployment your QA team will sign off on.
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