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.
Put AI inside deviations, RCA, queries and CAPA without risking a finding. Three tools, deployed and inspected, zero observations.
Explore → 02A way to validate something that learns. The AI Governance Stack, Annex 22-ready, decision integrity on top of data integrity.
Explore → 03Move from documentation volume to risk-based assurance across every site. The DRIVE framework and Modular Qualification.
Explore → 04Paperless, automated and vendor-neutral validation so new products and sites stop multiplying cost. One electronic backbone.
Explore → 05Risk-based qualification for SaaS and IaaS, shared-responsibility models, and a playbook that fits the cloud.
Explore → 06Make the eQMS intelligent. QMS 2.0, predictive quality KPIs, and a Pharma 4.0 data layer underneath.
Explore → 07LIMS, CDS, ELN, instruments and robotic cells validated as one data estate. The lab is where inspectors go first.
Explore → 08Independent, client-side leadership for Vault Quality: fit-gap, CSA-aligned validation, migration and multi-site rollout.
Explore →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 →