I work as the quality engineer for a fairly small service provider with many of our customers in the Life Sciences industry. Essentially what is provided by my Company is the system (Hardware & Software) that controls and automates the flows of material through valves, actuators and other accessories. Our customers may wish to use some of our verification and validation records in order for THEM to comply with FDA verification and/or validation requirements (which do apply to them and we would therefore wish to allow them to use our records as part of their FDA compliance requirements). My question is to better understand if and how 21CFR Part 11 requirements and cGMP requirements would apply to our business. We've been recently audited by one of our Life Science customers and they have asked that we provide 21CFR Part 11 training to our employees. Does anyone have any 21CFR Part 11 and/or cGMP Training Material? Am I missing something?