Expertise, Tailored to Your Needs

Services

Computerised System Validation

I offer comprehensive Computerized System Validation (CSV) services tailored specifically to your organisation. My flexible support covers the entire validation lifecycle, including:

  • Detailed validation planning and risk assessments
  • Validation protocols (IQ, OQ, PQ, UAT)
  • Efficient documentation and reporting
  • Flexible levels of support, from occasional reviews to full validation execution

With extensive experience in laboratory, clinical laboratory, and clinical trial settings, my approach ensures robust, secure, and compliant systems using optimized, risk-based methods.

Data Integrity Consulting

My Data Integrity services protect your organisation’s data accuracy and compliance. I perform detailed audits and risk assessments, ensuring adherence to industry-standard ALCOA++ principles:

  • Ensuring data is Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available and Traceable
  • Customised data governance frameworks
  • Advisory guidance and hands-on implementation

My solutions adapt to your specific needs and budget, enhancing data integrity throughout your processes.

Training and Coaching

I deliver engaging, customised training and coaching sessions tailored to QA professionals, auditors, and teams involved in computerised system validation. Sessions can include:

  • Interactive workshops
  • Webinars or blended formats
  • Practical demonstrations and hands-on practice

Using the mentoring method “see one, do one”. I ensure participants build practical skills and confidence, enhancing your team’s capability in CSV, auditing, and regulatory compliance.

Audit Support

My Audit Support services streamline regulatory audits (MHRA, EMA, and other regulatory bodies) with structured guidance at every stage:

  • Pre-audit preparation and strategic planning
  • On-site audit assistance for clarity and immediate response
  • Expert post-audit guidance to address and document findings effectively

I help reduce audit-related stress and ensure your organisation’s compliance remains robust, transparent, and well-documented.

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