This computer system validation training will show how you can document evidence to ensure that each computer system will fulfill its intended purpose in a GxP production, laboratory, or clinical research operation.
Why Should You Attend:
Many people have asked for specific guidance on what FDA expects them to do to ensure compliance with the Quality System regulation with regard to software validation. The extent of validation depends on the complexity of the computer system. The extent of validation at the user’s site also depends on the widespread use of the same software product and version.
This session is intended to help you avoid medical device related software problems that could have serious impact. The objective of Defining and Managing User Requirements is to document evidence that each computer system will fulfill its intended purpose in a GxP production, laboratory, or research operation.
Specific requirements for computers and electronic records and signatures are also defined in FDA’s regulations 21 CFR Part 11 on electronic Records and Signatures. This regulation applies to all FDA regulated areas and has specific requirements to ensure trustworthy, integrity and reliability of records generated, evaluated, transmitted and archived by computer systems.
Added by complianceonlinecom on February 20, 2013