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 → 09Computer system validation
The CSV discipline delivered across LIMS, eQMS, ERP, MES and equipment: full lifecycle, Part 11 and Annex 11, right-sized to the CSA standard.
Explore computer system validation → 10QMS harmonization
One quality system across sites and acquisitions instead of a patchwork. One process set, one eQMS design, one quality-data layer.
Explore QMS harmonization → 11 · paidInspection readiness review
A paid 90-minute session on the one system or AI use case that worries you most, with three moves in writing within 48 hours.
See the review →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 →