By Votion Solutions — Albany, NY · Serving worldwide
Technical Consulting for Biotech, Medical& Technology
Votion Solutions delivers hands-on technical and validation consulting — with deep specialization in biotech, pharmaceutical, and medical device environments, and the flexibility to support semiconductor, manufacturing, machine learning, and software projects across other industries. Worldwide, from Albany, NY.
Areas of Focus
Active
Regulated & Life Sciences
CQV, CSV, data integrity, and ML validation for pharma, biotech, and medical devices under FDA, EU GMP, and ISO 13485.
CQVGAMP 5FDA / EU GMPSaMD
Flagship · primary focus
Semiconductor & Adv. Manufacturing
Equipment and process qualification, fab automation, and yield/defect ML for semiconductor and high-tech manufacturing.
SEMIAutomationSPCYield ML
New focus · advanced mfg
Software, Data & ML
Software quality, ML and data engineering, and process automation for teams in any sector.
SDLCMLOpsCloud / DataAutomation
Expanding · all industries
Where We Focus
Three areas of focus. One standard of rigor.
Votion Solutions was built in regulated life sciences — and that discipline travels. We bring the same senior-led engineering rigor to semiconductor and advanced manufacturing, and to software, data, and ML projects in any sector.
Flagship · Primary Focus
Regulated & Life Sciences
Where our expertise runs deepest. Validation, qualification, and compliance for pharmaceutical, biotech, and medical-device organizations operating under FDA, EU GMP, and ISO 13485.
Computer System Validation & Data Integrity — 21 CFR Part 11, ALCOA+
Machine Learning Validation for SaMD — FDA AI/ML, ISO 13485
FDA & EU Regulatory Compliance — inspection readiness, gap analysis
New Focus · Advanced Mfg
Semiconductor & Advanced Manufacturing
Validation and engineering discipline applied to the fab. Equipment and process qualification, factory automation, and data-driven yield improvement for semiconductor and high-tech manufacturers.
Equipment & Process Qualification — SEMI standards, IQ/OQ/PQ, metrology
Manufacturing Automation & MES — factory automation, CIM, process control
Yield & Defect Analytics — ML for defect detection & yield prediction
Reliability & Functional Safety — SPC, ISO 26262 for automotive ICs
Expanding · All Industries
Technology, Software & ML
The same engineering discipline, without the regulatory overhead. Software quality, machine learning, data, and automation for teams in any sector — from startups to enterprises.
Software Quality & Validation — test automation, SDLC, CI/CD
Machine Learning & Data Engineering — MLOps, pipelines, model assurance
Digital Transformation & Automation — workflow, integration, tooling
Technical Due Diligence & Advisory — architecture & code review
Why Votion Solutions
A different model of consulting
Most consulting firms assign junior staff managed by distant partners. Votion Solutions operates differently — every engagement is delivered directly by the specialist with the relevant expertise.
Direct Access to Specialists
You work with the person doing the work — not an account manager who relays messages. Both co-founders engage directly with every client.
Deep Regulatory & Technical Knowledge
FDA, EU GMP, ICH, ISO 13485, GAMP 5 — fluency across regulated requirements, plus modern software, data, and ML engineering practice. The same rigor, wherever the stakes are high.
Boutique Speed and Rates
Senior expertise at boutique firm rates. No overhead layers, no large-firm markup. Free initial consultation on every engagement, scope and pricing agreed upfront.
Client Testimonials
What our clients say
"The team's expertise in CQV automation cut our commissioning timeline significantly. They bring a level of technical depth that is genuinely rare in this space."
SR
S. Rodriguez
Director of Engineering, Biotech Manufacturer
"Their machine learning validation framework gave our regulatory team everything needed for submission. They understand both the science and the FDA expectations — that combination is rare."
AP
A. Patel
Head of Regulatory Affairs, Medical Device Company
"They brought validation-grade discipline to our ML pipeline and release process without slowing the team down. Engineers who think about risk and shipping in the same breath are rare."
JL
J. Lin
CTO, Data & AI Platform
Industries & Sectors We Serve
Based in Albany, NY · Engagements delivered worldwide
Pharmaceutical Mfg
FDA · EU GMP · ICH
Medical Device
ISO 13485 · FDA 820 · EU MDR
Biotechnology
USP · EP · BP
Cell & Gene Therapy
ATMP · EU GDP
Clinical Research
GCP · 21 CFR Part 11
Digital Health & SaMD
SaMD · FDA AI/ML
Diagnostics / IVD
IVDR · FDA 510(k)
Semiconductor & Fabs
SEMI · IQ/OQ/PQ
Advanced Manufacturing
MES · Industry 4.0
AI / ML Products
Model Assurance · MLOps
Software & SaaS
SDLC · Cloud · Data
Free initial consultation. Always.
Every Votion Solutions engagement starts with a no-cost scoping conversation with a specialist — no pre-sales intermediaries.
Technical Consulting Services
Senior expertise. Direct access. Accelerated results.
Votion Solutions delivers hands-on technical and validation consulting — rooted in biotech, pharma, and medical devices, and extending to semiconductor, advanced manufacturing, machine learning, and software engineering for other industries. Worldwide, from our base in Albany, NY.
Core Services
Three practices. One team of senior specialists.
Our flagship work is regulated-industry validation. We bring the same engineering discipline to semiconductor and advanced manufacturing, and to software, data, and ML for clients in any sector — always delivered directly by a senior specialist.
Practice 01 · Flagship
Regulated & Validation Consulting
Our deepest expertise — for pharmaceutical, biotech, and medical-device organizations operating under FDA, EU GMP, and ISO 13485.
01
Commissioning, Qualification & Validation
Complete CQV services for manufacturing equipment, utilities, and facilities. From design qualification through performance qualification with full regulatory traceability and a risk-based approach aligned to FDA and EU GMP expectations.
GMPGAMP 5IQ/OQ/PQEU GMP Annex 15
CQV
02
Automation
Automated commissioning and qualification workflows that reduce manual effort, eliminate documentation bottlenecks, and accelerate validation cycles without compromising regulatory rigor — principles we apply equally to non-regulated operations. A core specialization of our team.
AutomationIQ/OQ/PQGAMP 5Risk-Based
AUT
03
Computer System Validation
Comprehensive CSV for laboratory instruments, LIMS, MES, ERP, and cloud-based GxP systems. 21 CFR Part 11 and EU Annex 11 compliance with full data integrity assurance throughout the validation lifecycle.
21 CFR Part 11EU Annex 11GAMP 5CSV
CSV
04
Machine Learning Validation
Validation frameworks for ML/AI models deployed in regulated pharmaceutical and medical device environments. Covers model qualification, performance monitoring, change control, and regulatory submission support. A core specialization of our team.
AI/MLFDA AI/ML GuidanceSaMDModel Governance
ML
05
FDA & EU Regulatory Compliance
Navigate FDA 21 CFR, EU GMP, EU GDP, EMA guidelines, and ICH requirements with confidence. Compliance assessments, inspection readiness programs, gap analyses, and remediation strategies tailored to your regulatory exposure.
FDAEMAEU GDPICH Q10
REG
06
Data Integrity & ALCOA+
Robust data integrity programs meeting current FDA and EMA expectations. ALCOA+ assessments, remediation roadmaps, and ongoing monitoring solutions aligned to MHRA, FDA, and WHO data integrity guidance.
ALCOA+MHRA DIFDA DI GuidanceWHO
DI
Practice 02 · Advanced Manufacturing
Semiconductor & Manufacturing Engineering
Validation-grade discipline applied to the fab and the factory floor — equipment qualification, automation, and data-driven yield improvement for semiconductor and high-tech manufacturers.
01
Equipment & Process Qualification
Qualification of fab tools, process equipment, and utilities to SEMI standards — IQ/OQ/PQ protocols, metrology and gauge studies, and process characterization that brings structured, traceable rigor to capacity ramps and tool installs.
SEMIIQ/OQ/PQMetrologyProcess Characterization
EQ
02
Manufacturing Automation & MES
Factory automation, CIM, and MES integration for high-volume manufacturing — equipment connectivity (SECS/GEM), recipe and process control, and the workflow automation discipline we honed in regulated environments applied to the production line.
MES / CIMSECS/GEMAutomationIndustry 4.0
MES
03
Yield, Defect & Reliability Analytics
Statistical process control, ML-driven defect detection, and yield prediction on high-dimensional fab data — plus reliability and functional-safety support, including ISO 26262 for automotive-grade and safety-critical components.
SPCYield MLDefect DetectionISO 26262
YLD
Practice 03 · All Industries
Software, Data & ML Engineering
The same rigor beyond the regulated world — software quality, machine learning, data, and automation for teams in any sector, from startups to enterprises.
01
Software Quality & Validation
Risk-based software validation, test automation, and SDLC quality assurance for web, cloud, and enterprise systems — bringing the discipline we apply to GxP software to product and engineering teams in any sector.
SDLCTest AutomationCloudCI/CD
SW
02
Machine Learning & Data Engineering
Model development support, MLOps, data pipeline design, and model assurance — spanning regulated SaMD, commercial AI products, and internal analytics platforms outside the life sciences.
MLOpsData PipelinesModel AssuranceAI
AI
03
Digital Transformation & Process Automation
Workflow automation, system integration, and process digitization that cut manual effort and error — translating hard-won lessons from regulated automation to operations in any industry.
AutomationIntegrationWorkflowEfficiency
DX
Engagement Models
Flexible ways to engage
Whether you need focused expert advice or a long-term embedded partner, we structure engagements around your needs.
Project-Based Engagement
Defined scope, timeline, and deliverables for validation projects, gap analyses, or inspection readiness programs with a clear end state.
Typical duration: 4–24 weeks
Fixed deliverable set with milestone reviews
Direct access to senior specialist throughout
Retainer & Embedded Advisory
Ongoing access to senior expertise — your dedicated specialist acts as an extension of your QA or engineering team.
Monthly retainer, minimum 3 months
10–40 hours per month of guaranteed access
Consistent relationship, no rotating contacts
Inspection Readiness Program
Intensive structured program to prepare your site for FDA or EMA inspection. Covers documentation review, procedural gaps, and readiness assessment.
Typically 4–8 weeks on-site or remote
Gap assessment plus remediation roadmap
Aligned to current FDA and EMA inspection priorities
Advisory & Expert Review
Focused expert opinion for document review, regulatory strategy questions, or technical guidance on a specific compliance challenge.
Available by the hour or as a day-rate block
Ideal for second opinions or targeted technical review
Response within one business day
Free initial consultation. Always.
Every Votion Solutions engagement starts with a no-cost scoping conversation with a specialist — no pre-sales intermediaries.
Client Results
Work we have done. Results that speak.
Representative engagements reflecting the type of work Votion Solutions delivers. Client names are withheld for confidentiality. Every result described reflects real project work.
Confidentiality Notice: All client names and identifying details are withheld. Outcomes are reported as delivered — we do not exaggerate results.
Pharmaceutical Distributor · Automation
Automated CQV program reduced commissioning cycle time for a multi-site distribution network
A pharmaceutical distributor operating multiple temperature-controlled facilities engaged Votion Solutions to redesign their commissioning and qualification process. Manual IQ/OQ/PQ documentation cycles were creating significant delays and resource strain across sites.
Votion Solutions designed and implemented an automated qualification framework aligned to EU GDP and GAMP 5. Protocol generation, execution tracking, and summary reporting were automated, substantially reducing cycle time and eliminating common documentation errors.
AutomationGAMP 5IQ/OQ/PQEU GDPMulti-Site
Reduced
Commissioning Cycle Time
Fewer
Documentation Errors
EU GDP
Compliant Output
Medical Device Company · ML Validation
Machine learning model validation framework for a regulated AI-assisted diagnostic system
A medical device company developing an AI-assisted diagnostic tool needed a validation framework for their ML model satisfying FDA SaMD requirements and supporting their 510(k) submission.
Votion Solutions designed a qualification protocol covering model performance specification, test dataset governance, equivalency testing, change control procedures, and post-market monitoring requirements — fully aligned to FDA's AI/ML-Based SaMD Action Plan and ISO 13485.
ML ValidationSaMDFDA AI/ML Guidance510(k) SupportISO 13485
SaMD
Validation Framework
510(k)
Submission Support
ISO
13485 Aligned
Biotech Organization · CSV & Data Integrity
Computer system validation and data integrity program for a cloud-based GxP platform deployment
A biotech organization migrating from an on-premises LIMS to a cloud-based GxP platform needed full CSV documentation and a data integrity gap assessment before going live in a regulated environment.
Votion Solutions delivered a risk-based CSV package aligned to GAMP 5 and 21 CFR Part 11, including user requirements, functional specifications, IQ/OQ/PQ protocols, and traceability matrices. A concurrent ALCOA+ assessment produced a prioritized remediation plan aligned to FDA and MHRA data integrity guidance.
CSVGAMP 521 CFR Part 11ALCOA+Cloud GxPMHRA DI Guidance
GAMP 5
CSV Package Delivered
ALCOA+
DI Gap Assessment
Cloud
GxP Compliant
Client Testimonials
What clients say about working with us
"The team's expertise in CQV automation genuinely changed how we approach qualification. They brought a level of technical sophistication we had not seen from a consulting partner before."
SR
S. Rodriguez
Director of Engineering, Biotech Manufacturer
"Their ML validation framework gave our regulatory team everything needed for submission. They understand both the science and the FDA expectations — that combination is rare."
AP
A. Patel
Head of Regulatory Affairs, Medical Device Company
"Working directly with the founders made all the difference. No handoffs, no junior staff — just experienced people who understood our compliance environment from day one."
MK
M. Kowalski
VP Quality, Pharmaceutical Distributor
Let us discuss what we can do for you.
A free initial consultation with a specialist — no obligation, no pre-sales process.
About Votion Solutions
Validation expertise. A better model.
Built by specialists who recognized that regulated industries deserve better consulting — expert-led, transparent, and structured around the client's outcomes, not the consultant's billing cycle.
Our Mission
Accelerating innovation in high-stakes industries
Votion Solutions was founded on a straightforward premise: regulated industries are still running validation programs built on outdated methodologies, and they deserve better — better tools, better methods, and a consulting model where the specialists you engage are the people who deliver.
We specialize in automation and machine learning validation for biotech, pharma, and medical device clients — and we bring the same engineering rigor to semiconductor and advanced manufacturing, and to software, data, and ML projects in other industries. Available worldwide from our base in Albany, New York.
Speed
We deliver results while large firms are still assembling project teams.
Cost Efficiency
Senior expertise without enterprise-firm overhead. Work with the people doing the work.
Innovation
Modern methods applied to compliance challenges that have long resisted improvement.
Transparency
Scope and pricing agreed upfront. We deliver exactly what was promised.
Why we built Votion Solutions
We watched regulated organizations spend enormous effort on compliance programs relying on outdated methodologies, generic software, and consulting teams where the most experienced people were furthest from the actual work. We believed there was a better way — and Votion Solutions is that model.
The Team
The people behind Votion Solutions
Votion Solutions is operated by two subject matter experts whose skills are complementary and whose commitment is the same: direct, senior-level delivery on every engagement.
N. Gurny (Founder)
Automation Specialist
Deep specialist in commissioning, qualification, and validation for pharmaceutical and biotech manufacturing environments, with a focus on automating CQV workflows to reduce cycle time, eliminate documentation bottlenecks, and accelerate regulatory readiness. Experienced across FDA 21 CFR, EU GMP Annex 15, EU GDP, and GAMP 5 frameworks. Works directly with clients on every engagement.
Specialist in validating machine learning and AI-driven systems within regulated pharmaceutical and medical device environments. Expertise spans ML model qualification, performance specification, post-market monitoring, and change control aligned to FDA AI/ML guidance for Software as a Medical Device (SaMD). Works directly with clients on every engagement.
ML ValidationAI/MLSaMDFDA AI/ML GuidanceISO 13485Model Governance
Our Values
Principles that guide every engagement
These are not values statements on a wall — they are the operating principles that determine how we scope, staff, and deliver every project.
Excellence Without Exceptions
In regulated environments, a 95% answer is a failed answer. We deliver complete, audit-ready outputs every time.
Principal Delivery
Every client works with the specialist doing the work. No handoffs, no interpretation layers, no junior stand-ins.
Radical Transparency
We tell clients what we find, even when uncomfortable. Sugarcoated assessments lead to inspection surprises.
Build Client Capability
Our goal is to make clients less reliant on consultants over time — we teach while we deliver.
Regulatory Frameworks We Work Within
FDA, EU, WHO, and international standards covered
21 CFR Part 11
Electronic Records
21 CFR Part 211
Current GMP
EU GDP 2013/C 343/01
Good Distribution Practice
EU GMP Annex 11
Computerised Systems
EU GMP Annex 15
Qualification & Validation
GAMP 5
Risk-Based Validation
FDA AI/ML SaMD
AI/ML as Medical Device
ISO 13485
Medical Devices QMS
MHRA DI Guidance
Data Integrity & ALCOA+
WHO GDP
Technical Report Series
ICH Q10
Pharma Quality System
ICH Q9
Quality Risk Management
SEMI Standards
Semiconductor Equipment
ISO 26262
Functional Safety
Work with the specialists directly.
No intermediaries, no junior handoffs. Every Votion Solutions engagement is delivered by a specialist.
Contact Votion Solutions
Let's discuss your project.
Whether you are preparing for an FDA or EMA inspection or looking for expert validation consulting — reach out. Every inquiry is handled directly by a specialist.
Get in Touch
Albany, NY. Serving clients worldwide.
Votion Solutions is headquartered in Albany, New York. We deliver consulting engagements to clients across North America, Europe, and Asia-Pacific. All inquiries are responded to directly by a specialist.
Headquarters
Votion Solutions LLC · Albany, NY · United States Consulting services delivered worldwide
Email
info@votionsolutions.com
Response Time
All inquiries receive a response within one business day. Free initial consultation available for every engagement.
Phone
Available upon request. Provided after initial email contact.
Regulatory Coverage
We work within FDA, EU GDP, EU GMP, EMA, WHO, ICH, ISO 13485, and MHRA regulatory frameworks. Mention the relevant regulation in your message and we will ensure the right specialist responds.