SEBALD CONSULTING: Your Partner in Meeting Regulatory Requirements
Headquartered in sunny San Diego, California, Sebald Consulting is dedicated to providing customized engineering support system and software developers that are targeting FDA and EMA regulated industries. If your software or computer related technology needs to meets Annex 11 and/or 21CFR11 requirements, we can put our decades of experience to work in finding gaps in your compliance, developing plans to address them, and getting your product to market as quickly as possible. These are not short-cuts but tried and true methods to get to a reliable, proven, and well documented system that can face the scrutiny of your partners, investors, and regulatory agencies. This can give you the best chance to meet your goals quickly. Projects may include web-based applications, AI projects, medical devices, manufacturing facility control systems, monitoring systems, etc.
We can contribute to projects of any size, from getting equipment up and running, getting through a compliance issue, or managing large projects, we are here to help where we can.
We have real-world industry experience designing and implementing systems and participating in FDA audits. Our experience includes electrical and process engineering, and project management. We also support computer system validation CSV and equipment qualification from conception through the full validation life cycle.