Understanding Computer System Validation (CSV)
Computer Systems Validation (CSV) is a process used to test, validate and formally document that a regulated computer-based system does exactly what it is designed to do in a consistent and accurate manner that is secure, reliable and traceable. The system has to be relied upon to:
- produce data accurately and consistently
- create an indelible electronic data trail that is transparent, traceable and tamper-proof
- store electronic data records in a way that is safe, secure and can stand the test of time
Computerised system validation and compliance is a regulatory requirement. Inadequate or inappropriate validation can lead to serious non-compliance and quality problems. Compliant and validated computer systems are a prerequisite for effective data integrity.
This course covers the key concepts of computer systems validation and provides practical guidance on how to comply with the regulations applicable to the pharmaceutical industry. It will include the regulatory requirements, the industry standards and best industry practice based on Good Automated Machine Practice (GAMP®5).
This course will provide a practical and efficient framework for computerised systems validation and compliance, and gives attendees an appreciation of how these ideas may be applied to their own systems and processes.
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Benefits of attending
- Gain a comprehensive overview of computer system validation (CSV)
- Enhance your understanding of the key terms used in CSV
- Recognise how Good Practices apply to computerised systems
- Understand the different approaches which might be employed
- Learn how to manage the risk associated with data integrity
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Average rating 4.7
My overall opinion is that this course was very worthwhile and well taught. I feel as though I learned a lot but I have learned in a way in which I will be able to apply this kn...
Good, well presented and full of information and knowledge
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International Professional & Industry Academy (IPI) is an international leading professional training organisation based in London. Our training solutions provide a return on your investment with measurable results, and are delivered by experienced professionals and managed with exceptional care and...
Paul gave a very informative and interactive course. He made the learning enjoyable, and it was obvious how knowledgeable he was.