Develop and maintain computer system validation (CSV) policies, procedures, and documentation in alignment with regulatory requirements (e.

g., FDA, EMA, GxP), industry standards (e.g., GAMP), and company quality management systems.

Lead and manage the execution of CSV projects, including risk assessments, validation planning, requirements gathering, testing, documentation, and validation reporting for computerized systems and software applications.

Define validation strategies, methodologies, and validation deliverables for various types of computer systems, including laboratory information management systems (LIMS), electronic data capture (EDC) systems, enterprise resource planning (ERP) systems, and quality management systems (QMS).

Conduct validation assessments and gap analyses for new or existing computer systems to identify validation gaps, risks, and opportunities for improvement, and develop remediation plans as needed.

Review and approve validation documentation, including validation plans, protocols, test scripts, traceability matrices, and validation reports, to ensure completeness, accuracy, and compliance with regulatory expectations.

Provide CSV guidance, training, and support to project teams, system owners, and validation professionals on validation principles, best practices, and regulatory expectations.

Stay informed about emerging trends, regulatory changes, and industry developments related to CSV, computerized systems, data integrity, and electronic records management, and recommend proactive measures to address evolving requirements.

Participate in regulatory inspections, audits, and assessments related to computer system validation, providing documentation, evidence, and support as needed to demonstrate compliance with regulatory requirements.

Last updated : 2024-04-03