2024 - 2026: DI Strategy Implementation for New Facility

Role: Lead Consultant

Customer: Global Biotech Company, Germany

Tasks:

Rollout of the existing Data Integrity strategy within a new facility

• Led implementation of the Data Integrity strategy
• trained stakeholders
• applied DI concepts in project delivery
• coordinated and led a team of consultants

Outcome

Enabled rollout of the Data Integrity strategy at a new site through training, implementation support, and team leadership

2025 - 2025: ML Validation Strategy for AVI

Role: Consultant

Customer: Global Pharmaceutical Manufacturer, Ireland

Tasks:

Validation approach for ML in AVI, including stakeholder training and workflow integration

• Developed the ML validation strategy
• designed and delivered a stakeholder workshop
• embedded the FDA draft 7-step AI/ML approach into the AVI workflow
• developed test strategies

Outcome

Established a structured validation approach for ML-enabled AVI with aligned stakeholders and risk-based test strategies

2025 - 2025: Validation Templates for ML-based AVI

Role: Lead Consultant

Customer: AI Software Provider, USA

Tasks:

Qualification and validation framework for AVI using unsupervised ML for anomaly detection

• Developed a template set aligned with FDA, EMA, and USP expectations; structured documentation for FS, HLRA, DS, IOQ planning, Train-Tune-Test considerations, and qualification strategy

Outcome

Delivered a template package for compliant qualification and validation of an unsupervised ML-based AVI solution

2023 - 2023: CRM CSV and Cloud Compliance Consulting

Role: Lead Consultant

Customer: Pharmaceutical Manufacturer, Germany

Tasks:

CSV strategy and cloud compliance consulting for implementation of a CRM system in project phase

• Provided high-level consulting on CSV scope and effort for the CRM validation project
• supported ongoing validation activities on demand
• prepared consulting sessions and documented recommendations in writing

Outcome

Supported definition of a risk-based CSV approach for the CRM system and provided written guidance for ongoing validation activities

2022 - 2022: DI Assessment

Role: Lead Consultant

Customer: Global Pharmaceutical Manufacturer, Germany

Tasks:

End-to-end Data Integrity assessment covering eight areas in scope, including preparation, on-site data collection, reporting, and consulting support

• Led the assessment across four phases: kick-off and preparation, GEMBA-based data collection, reporting, and consulting
• coordinated a two-person team of Team Lead and DI SME
• aligned activities with business conditions and agreed site availability

Outcome

Delivered a structured Data Integrity assessment across eight areas with reporting and consulting support to identify gaps and improvement needs

2021 - 2022: Global Data Integrity Framework

Role: Lead Consultant

Customer: Global Biotech Company, Germany

Tasks:

Data Integrity across all GxP areas; global policies with local implementation

• Developed the Data Integrity framework
• authored SOPs and policies on Data Governance, Data Integrity, Data Retention, Backup and Restore, Audit Trails and Audit Trail Review, and Access Controls
• created training materials; delivered training sessions
• supported a DI awareness campaign

Outcome

Established a global Data Integrity framework with governance documents and training materials for consistent local implementation

2021 - 2021: Data Integrity Workshop and Gap Assessment

Role: Lead Consultant

Customer: Global Software and Service Provider for Life Science, GCP, France

Tasks:

Data Integrity for GCP systems and services

• Lead Data Integrity workshop to train regulations (ICH E6) and best practices (ISPE GAMP framework)
• Lead Data Integrity assessment of procedures and their application
• Created report including remediation actions

Outcome

Strengthened Data Integrity knowledge; Gap assessment report and remediation plan

2019 - 2021: Data Integrity Program in Aseptic Filling

Role: Consultant

Customer: Global Pharmaceutical Company, Germany

Tasks:

Data Integrity program for aseptic filling operations, including procedural and validation support

• Authored Data Integrity Risk Assessments, Audit Trail Review Plans, and Data Retention Plans
• supported qualification and validation
• wrote a Backup and Restore SOP
• reviewed related local DI SOPs
• delivered trainings and workshops

Outcome

Strengthened the Data Integrity control framework for aseptic filling through documentation, training, and validation support

2018 - 2018: CSV Framework and QA Interim Leadership

Role: Interim QA Leader

Customer: In-vitro Diagnostics Manufacturer, Germany

Tasks:

Interim leadership of a QA group and development of a CSV framework aligned with ISO 13485:2016 and international guidelines

• Served as interim leader of a QA group
• developed a CSV framework in line with ISO 13485:2016 and relevant international guidelines
• provided audit support for ISO 13485 and MDSAP

Outcome

Established a compliant CSV framework and supported audit readiness for ISO 13485 and MDSAP

2017 - 2018: CSV and DI Implementation in Manufacturing and QC

Role: Consultant

Customer: Global Biopharmaceutical Manufacturer, Germany

Tasks:

CSV in manufacturing and Data Integrity implementation in the QC laboratory

• Supported CSV activities in manufacturing
• implemented Data Integrity concepts in the QC laboratory
• introduced Data Integrity SOPs

Outcome

Strengthened compliance in manufacturing and QC through CSV support, DI implementation, and SOP introduction