GxP validation, risk-based
Validation that keeps pace with your release calendar, not the other way around.
Mayona GxP provides:
- 01 End-to-end validation services for enterprise IT applications
- 02 Cloud system validation and vendor upgrade management
- 03 QMS, CAPA, periodic review governance, and procedure improvements
- 04 QAM audits — supplier, internal, and vendor qualification
- 05 Team building and GxP training
- a.FDA regulation 21 CFR Part 11
- b.Annex 11 — EU regulation
- 06 Implementation of CSA (Computer Software Assurance) program and framework
- 07 Application and infrastructure validation
Overview
One validation partner, from your first system to your fortieth.
We work with health-regulated companies at every size — funded biotechs standing up their first Veeva instance, and global manufacturers coordinating validation across a dozen platforms at once. The scope changes; the rigor doesn't.
Early-stage & scaling teams
Lean validation packages sized for your headcount, not a Fortune 500 SOP library. Get audit-ready without hiring a full quality function on day one.
Enterprise & global manufacturers
Multi-site, multi-platform validation programs with governance, tri-annual upgrade cycles, and traceability that holds up across every regional inspection.
Everything in between
Most of our clients are somewhere in the middle — one core GxP system, a handful of connected platforms, and a small team stretched thin. That's our sweet spot.
The problem we can help with
Validation shouldn't be why your release slips.
Every quarterly upgrade shouldn't trigger a six-week validation cycle. Every low-risk config change shouldn't need the same scripted testing as a GxP-critical feature. And every audit shouldn't come down to hoping your documentation holds up.
Traditional CSV treats every system the same — script everything, test everything, document everything. That's slow, expensive, and increasingly out of step with how regulated companies actually ship software today.
Our approach — why CSA, not CSV
Risk-based, not rubber-stamped.
Mayona builds validation around FDA's Computer Software Assurance (CSA) guidance — critical thinking over scripted documentation. High-risk, GxP-critical functions get rigorous testing. Low-risk functions get tested efficiently, using vendor evidence and unscripted testing where it's justified. The result: compliant, audit-ready systems without the padding.
Partner ecosystem
Experience in implementation and validation of below systems and platforms.
AWS · Google Cloud · Microsoft
Compliance-first cloud and infrastructure validation — data integrity, access control, and AI-ready foundations for regulated workloads.
Veeva, Salesforce, ServiceNow & more
Quality, clinical, CRM, ITSM, e-signature, and cold-chain platforms — each with a pre-scripted accelerated validation path.
See the full partner list
Every accelerator package, what it covers, and how fast it typically deploys.
How engagements run
From kickoff to a signed release package.
Scope & risk assess
We map your system's GxP impact and determine the assurance approach it actually needs — high-risk functions get rigor, low-risk functions don't get gold-plated.
Plan & strategize
We build the Validation Plan — approach, acceptance criteria, and roles — so everyone knows what "done" looks like before testing starts.
Test with critical thinking
Unscripted and exploratory testing where risk allows, formal scripted protocols only where warranted — leveraging vendor evidence and your team's expertise.
Capture assurance, not paperwork
Right-sized records — traceability, evidence, and rationale captured in real time, so documentation proves assurance without padding the file.
Release & sustain
Sign-off, plus a maintenance plan for your next quarterly or tri-annual platform upgrade.
Who we are
Built by validation experts, for regulated teams.
Mayona is an IT consulting firm delivering end-to-end services for FDA-regulated industries — project management, validation, testing, quality assurance, and program management. Founded by validation experts with over 12 years of combined experience, Mayona provides full lifecycle GxP validation across IT systems, processes, products, and equipment, spanning laboratory and manufacturing environments.
Our founders have spent their careers supporting pharma, biotech, and medical device clients — building and scaling resource organizations that place trained validation engineers with regulated companies. That hands-on foundation shapes how we work today. Independent Verification and Validation (IV&V) is one of the fastest-growing needs in FDA-regulated industries — Mayona is built to meet that demand.
More about our team →Have a platform waiting on validation?
Tell us what you're running and where it needs to land — we'll scope it honestly, sized to the work in front of you rather than a standard package.