Solutions

Computerised System Validation Services

Deloitte offer GxP Computerised System Lifecycle Validation Services to Life Science companies that operate in highly regulated environments.

Deloitte focuses on leveraging its understanding of GxP processes and technologies to provide a risk based cost-effective solutions to life science organisations.

Deloitte is aware of the latest thinking, current trends and best practice in the Life Science Industry with respect to Waterfall/ Agile frameworks in software development in a regulatory environment

Our team endorse a risk based approach to validation prioritising the processes and systems to assess. The validation strategy taken is tailored to a risk based strategy targeting the validation effort to where it is required.

Our experience can help you understand where the opportunities for improvement are in your current process and team, and  we can provide clear guidance on how to achieve regulatory compliance in your current environment.

There are a number of factors that position Deloitte as forerunners in the provision of Computerised System Validation (CSV) Services:

  • Our understanding of the regulatory requirements and the latest industry approach to validation
  • A team comprised of SME’s in validation to facilitate a successful compliance outcome
  • Our GxP/CSV advisory practice, working in conjunction with your team, to create a compliant waterfall/agile process in line with the required validation/regulatory standards
  • Our commitment to transferring knowledge to your team through on the job coaching with flexibility to work to your needs

All Deloitte Validation personnel are trained and experienced, allowing you to achieve compliance focussed on the regulatory environment you are working in. Working with Deloitte ensures you stay ahead of current and new regulatory requirements. Our proven success is manifested in successful validated client solutions that have withstood the rigour of regulatory body scrutiny.  We can assess systems/applications either on premise or remotely to deliver a solution that fits each organisation’s requirements and budget.

Meet the team

Eileen Healy

Eileen Healy

Partner - Operational Risk

Eileen is the Life Sciences partner lead in the Irish firm’s Risk Advisory practice. Eileen has over 20 years’ experience in the provision of risk, compliance and audit related services. Eileen leads ... More