Computer System Validation (CSV) professionals develop, review and conduct activities related to the validation of computer systems and processes to establish and ensure compliance. This involves all regulated systems through their life cycle including planning, requirements, specification, design, test, install and verification. Duties include:
- Review and evaluate computerized system validation (CSV) strategies, policies, standards, processes, SOP’s and other documents and provide guidance and counsel as needed.
- Develop and perform all CSV activities, documentation requirements and reports including plans, risk assessments, function requirements, configuration specifications, testing, change controls, traceability matrix, qualification protocols, validation and compliance reviews.
- Develop and complete deliverables as needed and in line with project/business objectives.