Faster from research to release. In control all the way.
Submission hubs, pharmacovigilance signals, GMP document control, and Part 11 / Annex 11 trails.
GxP-aware knowledge without shadow IT
Quality, regulatory, and safety functions cannot afford ambiguous sources. When AI assists drafting or signal detection, outputs must map to controlled documents, validated systems, and the reviewers who approved them.
KnowledgeHub keeps corpus boundaries explicit, versions artefacts, and records prompts, models, and human decisions, supporting submission readiness, PV case work, and manufacturing document control in environments where deviations become regulatory events.
Controlled document search with access aligned to quality and safety roles
Lineage from generated summaries or extractions back to the underlying record
Separation of draft assistance from released records through workflow gates you define
How quality and PV functions shorten evidence cycles without bypassing controlled records
GxP regimes demand controlled narratives: deviations/CAPA, pharmacovigilance case narratives, study reports, validated SOPs, and batch records, with strict separation between draft assistance and released truth.
Common pains where unstructured data and agents matter
- 01
Deviations reference historic versions the organisation cannot find instantly
Older CAPA annexes linger in ECM without obvious obsolescence flags.
Version-aware corpus search highlights effective vs superseded wording before closure.
- 02
PV CASE ASSESSMENTS PULL FROM UNSTRUCTURED LITERATURE INCONSISTENTLY
Signals demand narrative synthesis referencing approved benefit-risk language.
Agents propose cited excerpts; safety physicians decide.
- 03
Generative drafting risks mixing draft with released artefacts
Shortcuts publish AI prose into controlled spaces.
Workflow gates segregate drafts, record prompts/models, and require human reviewers before issuance.
Outcomes organisations typically target
- Faster, safer authoring cycles under GxP scrutiny
- Consistent literature and SOP grounding for PV drafts
- Explicit separation between assistive drafts and controlled records
Easy to start. Safe to stop.
The pilot runs at a fixed price: we map the workflow, deploy it in your environment and prove it on your own cases. Then you decide.
Fixed price · Fixed timeframe
- 01
Map the workflow
Two weeks with your people where we document what happens today, including the parts nobody wrote down.
- 02
Deploy in your environment
Inside your tenancy, on your data residency terms, with no exports and nothing leaving through the side door.
- 03
Prove it under audit
Controlled evaluation against your own cases with compliance and the process owner signing off before go-live.
- 04
Run in production
We stay on with retraining, reporting and ongoing oversight for as long as the workflow runs.
Fixed price, Fixed timeframe. 8–12 weeks pilot: Continue (Expand once you know it works) / Stop.