Computer Systems Validation (CSV) is a process used to ensure that a computer-based systems will produce information or data that meet a set of defined requirements. The process is used within highly regulated environments that directly impact public health and safety such as pharmaceutical and medical device manufacturing. Computer validation is more than a compliance requirement. It not only reduces regulatory risk, but it also increases understanding of system during project implementation and enforces a structured, well-defined execution of the project. Pharmaceutical computer system validation is a unique opportunity for a business to examine their computer systems to maximize effectiveness and enhance quality, with the potential to save cost and time. Subject matter expert (SME) of CSV will have a major role in achieving these benefits. This course will be of benefit to anyone involved in FDA audits and Computer Systems Validation (CSV) on both a domestic and global scale. Additionally, this course will be highly-relevant to those in Quality Assurance, Compliance, Validation, Informatics, Procurement, R&D, Commercial, Quality Control and other job functions which are impacted by CSV efforts. This course is particularly useful to those who interface with vendors, FDA and other regulatory agencies.
This course will provide extensive training in Computer system validation. The process is used within highly regulated environments that directly impact public health and safety such as pharmaceutical and medical device manufacturing. It’s crucial that any process within these manufacturing industries reliably behaves in a consistent way.
Pharmaceutical manufacturing and medical device manufacturing industries are increasingly relying on computer systems to operate a range of manufacturing processes, so it’s more important than ever that these systems can be relied upon to follow a predetermined specification.
So what exactly does CSV deliver to these industries?