Senior Validation Consultant · GxP Compliance & Digitalization

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 for software supplier assessments.

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Anna Paleczny

Senior Validation Consultant | Lead Auditor, CSV Supplier Audits

// GxP experience

15+

years across Pharma & Biotech, Europe and the US

// expertise

Senior Validation Consultant

GxP Compliance, CSV Strategy & Digital Transformation in Regulated Environments

// independent consulting

years delivering validation expertise as an independent consultant

// background

MSc Biomedical Engineering

// based in

Munich, Germany

projects across Europe & globally

Validation expertise

When validation becomes business-critical

Effective validation starts with the right decisions: defining scope, requirements, assessing risks and establishing a practical path to compliance.

I work with QA, IT and business teams across Pharma, Biotech and MedTech to develop validation strategies aligned with regulatory expectations and operational needs.

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.

Validation strategy needs to be defined

New projects require a risk-based validation approach, clear responsibilities and a practical roadmap before execution begins.

Validation gaps need assessment

Existing systems, documentation or processes require a structured gap assessment to identify risks, remediation actions and compliance priorities.

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.

A vendor change, cloud migration or technology transformation is planned

New technologies and shared responsibility models require a validation concept aligned with GxP requirements and regulatory expectations.

Validation processes need improvement

Organizations need to optimize validation approaches, reduce unnecessary effort and implement efficient, risk-based practices while maintaining compliance.

Expertise

Core Validation Expertise

Intelligent validation approaches that connect business needs, technology and regulatory expectations.

Lead Auditor | CSV 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

Defining validation 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 the validation of individual systems.

Digital Transformation & Enterprise Systems

Supporting digital transformation in regulated environments by 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.

Applying risk-based approaches aligned with GAMP 5 infrastructure qualification principles and supplier responsibility models.

GxP Compliance Assessments & Remediation

Performing independent CSV gap assessments and regulatory compliance reviews to identify risks, define remediation priorities and strengthen validation maturity.

Supporting organizations in addressing gaps against current GxP expectations, data integrity principles and regulatory requirements.

FDA Inspection Readiness & Audit Support

Preparing computerized systems and validation documentation for FDA inspections and regulatory audits — ensuring system validation 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.

Regulatory & Industry Standards

Computer System Validation (CSV) Computer Software Assurance (CSA) GAMP 5 FDA 21 CFR Part 11 EU GMP Annex 11 ICH Q10 PIC/S ALCOA+

Systems & platforms

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 validation 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

Examples of platforms: SAP · OneWorld ERP · JD Edwards · PLM · OrderWise WMS · LIMS · Empower · Chromeleon · OpenLab · LabX · MassLynx · ValGenesis · MasterControl · TrackWise · SCADA · Sartorius MFCS · ELPRO · AWS

Intelligent validation.Critical thinking meets compliance.