Computer System Validation (CSV) Expert/Life Sciences & Regulatory

I am a seasoned consultant and expert in Regulatory Compliance, Quality Assurance, and Computer System Validation (CSV) with over 15 years of experience in the pharmaceutical industry. My extensive background includes:

Regulatory Compliance: I have successfully navigated complex regulatory requirements, ensuring adherence to standards set by FDA, EMA, and other global health authorities. My deep understanding of regulatory frameworks has consistently guided companies through complex audits and inspections.

Quality Assurance: I specialize in creating, reviewing, and maintaining comprehensive documentation that meets all regulatory expectations. This includes developing validation plans, protocols, and reports to ensure compliance with current Good Manufacturing Practices (cGMP) and Good Automated Manufacturing Practice (GAMP) guidelines.

Computer System Validation (CSV): With solid experience in CSV for GxP critical systems, I am well-versed in regulatory standards such as US FDA 21 CFR Part 11, EU EudraLex Annex 11, ISPE GAMP5, US FDA 21 CFR Part 820, and ICH Q10. I have validated various software and applications, including SAP modules, CMMS, PharmaSync, and Automated Logic’s WebCTRL.

Throughout my career, I have developed and executed validation strategies, conducted risk assessments, and managed remediation projects with a detail-oriented approach. My commitment to excellence and passion for upholding the highest standards of regulatory compliance have earned me a reputation as a trusted advisor in the industry.

Services I provide include:

Computer System Validation: Validating new or updated software, databases, and computer systems as per 21 CFR requirements.

Part 11 Assessments: Assessing the compliance status of your computer systems.

Process and Equipment Validation: Ensuring all controlled systems and processes are compliant with relevant regulations.

QMS Documentation and Regulatory Writing: Expertise in writing regulatory content, technical articles, Sops for Pharma and blog posts.

I have worked with a diverse range of clients, from small biotech startups to large multinational pharmaceutical companies, helping them achieve and maintain compliance throughout the product life-cycle. My experience includes leading cross-functional teams, conducting training sessions, and mentoring junior staff to build robust compliance cultures within organizations.

Contact me today to discuss your Regulatory Compliance, Computer System Validation (CSV), and QMS document development needs, and embark on a journey towards pharmaceutical excellence.