Problems you know. Frameworks that solve them.
Eight connected services, organised around the problem in your words rather than a product I want to sell. Most clients start with one and grow into the next. The work is senior-led and built to survive an inspection, because most of it already has.
The first conversation is free and useful by design: you leave with three concrete next moves. I lead a small number of programmes at a time.
AI-enabled QMS
Put AI inside deviations, RCA, queries and CAPA without risking a finding. More than 20 tools deployed in live GxP quality, validated and audit-ready.
Explore → 02AI in GxP governance
A way to validate something that learns. The AI Governance Stack, Annex 22-ready, decision integrity on top of data integrity.
Explore → 03CSV to CSA
Move from documentation volume to risk-based assurance across every site. The DRIVE framework and Modular Qualification.
Explore → 04Digital Validation
Paperless, automated and vendor-neutral validation so new products and sites stop multiplying cost. One electronic backbone.
Explore → 05Cloud GxP validation
Risk-based qualification for SaaS and IaaS, shared-responsibility models, and a playbook that fits the cloud.
Explore → 06Digital Quality & QMS
Make the eQMS intelligent. QMS 2.0, predictive quality KPIs, and a Pharma 4.0 data layer underneath.
Explore → 07Lab Systems & Automation
LIMS, CDS, ELN, instruments and robotic cells validated as one data estate. The lab is where inspectors go first.
Explore → 08Deploying Veeva
Independent, client-side leadership for Vault Quality: fit-gap, CSA-aligned validation, migration and multi-site rollout.
Explore →For validation, quality-tech and AI vendors
If you build software for regulated quality, independent advisory makes your product more credible to the buyers who matter. This is advisory, never paid endorsement, and it stays at arm's length from the client work above.
Vendor advisory →