A basic introduction to the main features and benefits of Ellabs ValSuite validation software.
Software validation webinar. We will explain the role of Risk Management in Non-Product Validation. Then to provide a solid. Non Product Software Validation is a challenging area and SSI will have a conversation with an industry SME Tom Bento on what defensible compliance is critical thinking and your checklist for Validation of NPS and defining the entire scope of what Validation of Non Product Software should look like.
This webinar describes the validation planning process with particular emphasis on avoiding six common pitfalls. What is the appropriate sample size for software testing. How to apply IQ OQ and PQ techniques to software.
For decades now computer system validation CSV has revolved around the thump factor. The approach to developing software performing validation and maintaining a system in a validated state through its entire life cycle should be carefully considered in order to meet changing needs. This webinar will teach you how to design build and test medical device software in preparation for the successful 510k submissions.
Areas Covered in the Webinar. In this free 60-minute webinar Joe Cassar of dSPACE discusses the benefits methods and processes associated with virtualized vehicle software verification and validation. Development of software test plans.
Most recalls can be traced back to computerized equipment exposing the validation process to scrutiny. This course will teach how to comply with 21 CFR Part 82070i and effectively implement a software validation program for medical devices meeting the FDA requirements and produce a safe product. This FDA software validation training will discuss how to approach strategic software validation planning so as to satisfy FDA by complying to new enforcement initiatives by FDA.
How does Software Validation relate to Design Validation. Increased use of software from automated manufacturing and quality systems means increased exposure. This webinar will address the use of the FDA GAMP and other applicable industry software validation models coupled with the ISO 14971 model to structure run and document acceptable software validations.