Software Validation of IT Systems and Production Equipment

I support organisations with validation of software and computerised systems used in regulated business processes, Quality Management Systems and production equipment.
My experience includes software used in IT systems, Quality Management processes and production equipment in regulated life science environments.

Areas of Support

I can support organisations with:

• Establishment and improvement of Software Validation processes
• Validation strategy and planning
• User Requirements Specifications (URS)
• Risk-based validation approaches
• Validation plans, protocols and reports
• Traceability between requirements, risks and testing
• Review and improvement of existing validation documentation
• Validation of software used in production equipment
• Implementation and validation of IT systems in regulated environments
• Training and knowledge transfer

Risk-Based Approach

The extent of validation should be based on the intended use of the system and the associated risks.
I use a structured and risk-based approach to define the appropriate level of documentation, testing and control, with focus on ensuring compliance without creating unnecessary complexity.

Experience

My experience includes validation of IT systems and software supporting regulated processes across Quality and Operations, including software integrated into production equipment.
I have also been involved in implementation of IT systems supporting Quality Management processes, where validation forms an integrated part of the overall implementation.

Regulatory and Quality Frameworks

My experience includes Software Validation in accordance with applicable regulatory and quality requirements in regulated life science environments.

If you would like support with Software Validation of an IT system, Quality Management System or production equipment, you are welcome to contact me.