Rodrigo ÁlvarezConsulting S.L.U.Connect on LinkedIn
Senior CSV / CSA & IT QA Consultant

Rapid GxP, SaMD & AI Software Validation Packages & Services

Combining 10+ years of Computer System Validation (CSV/CSA) rigor with AI-assisted documentation workflows to deliver audit-ready compliance — from fast-growing HealthTechs to established Life Sciences enterprises. Agile execution, zero bureaucratic drag, 100% remote.

Services & Engagement Models
10+ YearsIn CSV / IT QA & GxP Compliance
GAMP 5 & IEC 62304Pharma & Medical Device Normative Mastery
Agile ExecutionDelivery scaled to project complexity
Proven Track RecordDelivered across Pharma, Biotech & HealthTech
Services & Engagement Models

Pragmatic validation solutions for GxP software, SaMD, and AI systems — tailored for scaling HealthTech startups and established Life Sciences enterprises.

For Biotech, SaMD & HealthTech

Fast-Track SaMD & AI Validation Packages

Audit-ready GxP & medical software validation dossiers tailored for agile engineering teams. Designed to satisfy FDA, CE Mark (MDR), and Health Authority requirements without slowing down product releases.

Engagement ModelsFixed-Price Turnkey Package / Advisory Retainer / Project-Based / Senior Consultant Augmentation
  • SaMD & AI Software Regulatory StrategyClassification, regulatory pathway determination, and validation master planning (VMP) compliant with ISO 13485, IEC 62304, and FDA Software Functions guidance.
  • AI/ML Medical Algorithm Compliance & ValidationGood Machine Learning Practice (GMLP) implementation, data integrity protocols for training datasets, model performance verification, and continuous monitoring controls.
  • Agile Technical Documentation & Risk ManagementAI-assisted generation of URS/FS, ISO 14971 Risk Management Files (FMEA), Hazard Analysis, and automated Traceability Matrices linked directly to code.
  • Developer-Friendly IQ/OQ/PQ Protocol ExecutionIntegration into modern developer stacks (Jira, Confluence, GitHub, GitLab) for automated test execution, electronic signatures, and audit-ready evidence capture.
  • Vendor Assessment & Cloud GxP QualificationComprehensive auditing of third-party cloud infrastructure (AWS, Azure) and SaaS dependencies to guarantee end-to-end 21 CFR Part 11 and EU Annex 11 compliance.
  • Audit Defense & Technical File Dossier CompilationFinal compilation of the complete Validation Summary Report (VSR) and Technical Dossier ready for Notified Bodies (TÜV, BSI), FDA submissions, or external audits.
For Established Biotech, Pharma & Mid-Market

Enterprise CSV / CSA & GxP System Consulting

Strategic advisory, staff augmentation, and GxP software validation for scaling Biotechs, Life Sciences mid-market, and established Pharma enterprises.

Engagement ModelsFixed-Price Turnkey Package / Advisory Retainer / Project-Based / Senior Consultant Augmentation
  • GxP Software & AI-Based System ValidationEnd-to-end life-cycle validation (GAMP 5 2nd Ed.) for GxP computerized systems, eQMS, ERP (SAP), cloud applications, and vanguard AI/ML-driven software deployed in regulated environments.
  • CSV to CSA Modernization & EnablementTransitioning traditional QA/IT departments from rigid CSV paperwork toward efficient, risk-driven Computer Software Assurance (CSA) and Critical Thinking frameworks.
  • GxP IT Integration in M&A & In-LicensingStrategic oversight and zero-gap data integrity management for computerized systems during corporate mergers, acquisitions, or asset in-licensing deals.
  • Data Integrity Remediation & High-Stakes RescueRapid recovery programs for systems and sites facing FDA Warning Letters, EMA non-compliance, or critical audit deficiencies under ALCOA+ frameworks.
  • Lean IT QMS Design & Compliance GovernanceImplementing streamlined, audit-ready Quality Management Systems (SOPs, WIs, policies) optimized for modern cloud platforms and agile delivery.
  • Cloud & Infrastructure Qualification (AWS / Azure)Formal qualification strategies for GxP-critical cloud environments, networks, and scalable IT infrastructure without sacrificing deployment velocity.
  • Inspection Readiness, IT Audits & Fractional QA LeadershipComprehensive GxP system auditing, Health Authority inspection defense (FDA/EMA), vendor assessments, and interim IT QA Director oversight.
The Approach

Modern GxP Assurance vs. Traditional Consulting

Replacing paper-heavy compliance with critical thinking, automation, and direct senior expertise.

Quality Over Pure Compliance (CSA Framework)

Applying GAMP 5 (2nd Ed.) Computer Software Assurance principles to eliminate bureaucratic bloat. The focus shifts from generating endless, low-value paperwork to risk-proportionate testing and real software robustness.

Agile & DevOps Native Integration

Embedding compliance directly into modern engineering workflows (Jira, GitHub, Cloud). Streamlined evidence capture and continuous verification aligned with rapid release cycles — without forcing legacy QA tools onto developer teams.

AI-Assisted Documentation Velocity

Leveraging custom LLM workflows and GxP-validated prompts to accelerate initial drafting of protocols, software specifications, technical documentation, and risk matrices — freeing senior time for high-level quality architecture and critical review.

Senior Authority, Zero Corporate Overhead

Direct, end-to-end engagement with a Senior Compliance Architect (10+ years GxP experience). No junior handoffs, no account managers, and no wasted corporate meetings.

Trusted by Select Life Sciences Enterprises
Novartis
Johnson & Johnson
MorphoSys
Grifols
Actelion