Syntegrity™ is a maturity model and a set of human-in-the-loop AI tools that measure how coherent, integrated, and inspection-ready a pharmaceutical quality system really is — where most GMP failures actually happen: at the handoffs between functions and across the lifecycle.
Most GMP failures don’t happen inside functions — they happen at the seams between them. Syntegrity™ makes those seams measurable.
Each pillar maps a way a quality system stays whole across functions and the product lifecycle — and each is anchored to the standards inspectors actually cite.
Inputs, scope and requirements controlled and agreed before work begins.
Design, validation and operation connected across the lifecycle — no orphaned handoffs.
Traceable, attributable, reconstructable records — data you can stand behind.
Effort and rigor proportionate to risk — decisions justified, not asserted.
Prevention over reaction — trends acted on before they become findings.
Decision-support tools for quality records — each produces a draft for a qualified person to review, never a final decision.
Score a record’s maturity across the five pillars — evidence-based, with a gap analysis anchored to named standards.
A regulation-anchored completeness pass: what’s missing, what to fix, every finding citing its clause.
Baseline drafts from structured input — never fabricated; blanks become [NEEDS INPUT], not invented data.
A client-ready package: review report, redline, and tracked suggested-fixes to accept or reject.
The Scientific Systems Architect role that drives the model at project level — turning framework into design decisions grounded in real systems.
Every output is a draft. AI does the tireless completeness-and-consistency pass; a qualified person owns the disposition and the sign-off. Accountability stays with people.
Findings trace to the frameworks inspectors use — not to opinion. Built for defensibility under audit.
Backlog triage, investigation and CAPA quality, inspection-readiness, or a scoped pilot on your own records — let’s talk about the fit.
Email aaviles@syntegrity.ioArmando Aviles · Biopharma Quality Consultant