Computer software validation has been a major issue for medical device manufacturers and is one of the leading causes of 483 observations, warning letters and product recalls. There are many different types of computer hardware and software found in the medical device industry, including:
COTS (Commercial Off-The-Shelf) applications
Custom in-house applications (databases and spreadsheets, web apps, etc)
Software embedded in medical devices
Software used to create or manufacture devices
All of the above must be validated for intended use and be under strict change control. The risk to patients can be severe for even small software bugs, and the cost of legal actions or product recalls can be financially devastating. The following topics will be covered in detail:
A review of recent enforcement actions as a result of inappropriate computer system validations.
The basics of computer software validation and what is expected in any validation effort.
A presentation of Ofni System’s methodology for how we create functional requirements, design specifications and test cases.
Education for users about specific hot spots, including Change Control and Risk Assessments.
A discussion of new technologies for automated testing and electronic protocol execution.
e-Conference, Presented by the Clinical Device Group