I agree with the previous commenters that it's important to have a solution or plan before raising the alarm. Having said that, once you raise the alarm and you're not being heard to your satisfication, there are several options available: * First, clear your mind of what you think you know about software development and what SHOULD be and try to see the situation from an open-minded perspective. Are the issues you're seeing really an indicator of poor quality or are they an indicator of a system that's different from what you know/like? As a quality/regulatory person myself, I've seen many unnecessary projects and alarm bells simply because of a lack of understanding/perspective on a given topic. I'm not saying that's the case with you, just that this is the kind of issue that's good to be absolutely clear with yourself about. * Once you're clear that there is in fact an issue, go to QA and request an internal audit on your software development/quality systems. If your QA team doesn't have a procedure by which you can request an audit, then you should find a QA partner who can work with you on this. It's good to have a QA partner anyway so building the bridge on this project won't be a waste of time regardless of the outcome. * If auditing isn't an option, or if you need ammo to sell the audit idea, another approach is to analyze deviation and/or CAPA trends on your software development process, as well as your validation process. For example, try to find out how many validation deviations are being generated when new/updated software is released from your development team. Working with QA, you could develop an estimated cost-per-deviation, which would be a huge pile of ammo for your management presentation. Also, pretty charts and graphs will help too. * Find other tangible evidence of the issue. Without specific examples it will be difficult to be clear about the problem and/or the solution(s). * If you find evidence and QA and/or management still won't listen, it's time to consider your options. You can either stay, knowing that a ticking time-bomb exists, or you should carefully plan and execute your exit from the company. My litmus test for working at a company is to regularly ask myself whether I'd give my company's medicine to a family-member [a family member I love :P ]. If the answer is no, I don't stick around. So far, I've only had to do that once in 10 years and it was absolutely the right choice. Good luck!