Intelligent validation.
Critical thinking meets compliance.
Senior Validation Consultant specializing in GxP computerized systems, risk-based validation strategies and regulatory compliance across Pharma and Biotech. Lead Auditor, CSV Software Supplier Audits.
When validation becomes business-critical
The right decisions come first: defining scope, requirements, assessing risks and establishing a practical path to compliance.
Strategies built around how your organization actually operates, not a template applied from outside. I work with business, quality and other subject matter experts across Pharma and Biotech to define the best solution.
A new GxP system is being introduced
SAP, LIMS, eQMS and other GxP computerized systems supporting manufacturing, laboratory and quality operations require a validation strategy that aligns business objectives, regulatory expectations and implementation timelines.
A clear approach needs to be defined
Before execution begins, new projects need a defined, risk-based approach with clear ownership.
Compliance gaps need assessment
A structured gap assessment identifies risks, remediation actions and compliance priorities across existing systems, documentation and processes.
A regulatory inspection or audit is approaching
FDA, EMA or other regulatory inspections require organizations to demonstrate a clear validation state, robust documentation, effective data integrity controls and audit readiness.
Cloud migration or technology change is underway
Shifting to a new platform or provider means renegotiating who owns what in the validation lifecycle, before go-live, not after.
Existing approaches need improvement
Organizations need to streamline validation approaches, cut unnecessary effort and scale practices to actual risk, while maintaining compliance.
Core Validation Expertise
Intelligent approaches that connect business needs, technology and regulatory expectations.
Lead Auditor, CSV Software Supplier Audits
Full-scope audits of software, SaaS and PaaS vendors for pharmaceutical organizations, covering SDLC, Quality Management Systems (QMS), risk management, supplier management, infrastructure, backup and disaster recovery.
Assessments performed against GxP requirements, GAMP 5, EU GMP Annex 11, FDA 21 CFR Part 11 and ISO 9001.
Validation Strategy & Lifecycle Management
Building compliance strategies for complex GxP environments, including Validation Master Plans (VMP), governance models, risk-based approaches and lifecycle management across manufacturing, laboratory and quality systems — from enterprise-wide strategy down to individual system qualification.
Digital Transformation & Enterprise Systems
Digital transformation in regulated environments depends on validating new enterprise platforms, system upgrades and technology-enabled processes.
Aligning business objectives, IT implementation and regulatory expectations to achieve compliant go-live and sustainable operation.
Infrastructure Qualification & Cloud
Supporting the qualification of cloud environments and infrastructure supporting GxP systems, including AWS services, servers, databases, networks, backup and disaster recovery processes.
Qualification effort is aligned with GAMP 5 infrastructure principles and supplier responsibility models, scaled to risk.
GxP Compliance Assessments & Remediation
Performing independent CSV gap assessments and regulatory compliance reviews to identify risks, define remediation priorities and strengthen validation maturity.
Gap closure is prioritized against current GxP expectations, data integrity principles and regulatory requirements, turning findings into an actionable remediation plan.
FDA Inspection Readiness & Audit Support
Preparing computerized systems and supporting documentation for FDA inspections and regulatory audits — ensuring records, data integrity controls and audit trails withstand scrutiny.
Experience supporting FDA pre-approval inspection (PAI) readiness specifically for validated computerized systems, within the broader site inspection effort.
Systems & Technology Landscape
Experience across diverse GxP computerized systems and technology environments, supporting laboratory, manufacturing, quality and enterprise operations.
Laboratory & analytical systems
GxP laboratory platforms, including LIMS, CDS (chromatography data systems) and analytical systems
Manufacturing & operational systems
PMS, SCADA, process control and monitoring systems (e.g. Sartorius MFCS)
Quality & validation systems
eQMS, document management and compliance platforms
Enterprise & business systems
ERP, PLM, WMS and business-critical applications
Cloud & infrastructure environments
Cloud platforms, infrastructure and services supporting GxP applications
Emerging technologies
AI/ML-enabled systems and evolving validation approaches aligned with current GxP expectations