SALGADO ADVISORY · San Diego, CA
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AI Governance for GxP Quality Systems

Does AI touch your quality system?

The EU AI Act's next enforcement phase is in effect, FDA has published its expectations for AI model credibility, and AI features are already shipping inside your eQMS, LIMS, and document workflows. Most quality teams cannot yet say where their exposure sits. I help you find out — in two weeks, with a documented method.

Book a 20-minute exposure review Free. No deck, no pitch — bring your system list, leave with a first read on your risk.
The engagement

AI Readiness Gap Assessment for GxP Quality Systems

A two-week, fixed-scope assessment for pharma, biologics, and medical device quality organizations. No open-ended consulting retainer — a defined method, a defined deliverable, a defined price.

01
InventoryEvery AI/ML touchpoint in your QMS and validated systems — including the features your vendors switched on without asking.
02
Gap matrixEach touchpoint scored against the FDA AI credibility framework, 21 CFR Part 11 / CSA, and EU AI Act risk tiers.
03
RoadmapA risk-ranked 90-day remediation plan your team can execute — sequenced by patient risk and audit exposure.
04
Executive readoutA 60-minute briefing that gives QA leadership and the C-suite the same defensible answer.
$4,995 pilot rate, first three clients · $7,500 list · fixed scope, two weeks
Verified results
18%
reduction in documentation nonconformance
THERMO FISHER SCIENTIFIC
25%
acceleration in batch release
AJINOMOTO BIO-PHARMA
99%
ERP data accuracy sustained
VICAL
Who you're working with

Abel Salgado

Ten-plus years implementing the quality systems that keep regulated products moving and audits clean — Veeva Vault and Oracle Cloud eQMS environments across pharma, biologics, and medical device. Document control, CAPA and deviation management, CSV/CSA, and CMO/CDMO oversight under 21 CFR Parts 11, 210/211, 820, and EU Annex 11.

Most AI experts can't tell you what enforcement means for a validated system. Most QA teams can't tell you where AI has already crept into theirs. I work in the overlap — bringing the same validation rigor to AI that I'd bring to any GxP system.

MBA · B.S. BIOCHEMISTRY & MOLECULAR BIOLOGY
AIGP CANDIDATE · EXAM AUG 2026
BILINGUAL ENGLISH / SPANISH · SAN DIEGO · ON-SITE OR REMOTE
Next step

Book a 20-minute exposure review

Bring a list of your quality systems. In twenty minutes you'll have a first read on where AI likely already touches them and whether a full assessment is worth your budget. If it isn't, I'll tell you that too.

Pick a time Prefer email? abelsalgado@gmail.com