Call Today - (844) HIRE-ASI Home Services Industries Served Careers About Us Contact Us Bringing Value, Enhancing Outcomes Dependable FDA Compliance Services Nationwide FDA Compliance Services It is critical to maintain your FDA compliance with regulations and guidance set forth by the FDA and its worldwide counterparts. ASI helps you do that by implementing workable strategies for key areas such as risk management and data integrity. ASI also provides auditing, gap assessments, and quality assurance project management services. Get peace of mind knowing that your business is operating in FDA compliance with all applicable regulations. This is our specialty, so trust us to help. FDA Response and Remediation ASI provides help when you need assistance responding to FDA and its European counterparts’ enforcement actions. We also help with the required remediation efforts. Quality Systems We help you build a quality system with management in the middle. From technical writing to gap analysis, we guide you every step of the way. Risk Management ASI helps your company by guiding clients to integrate the risk management system into your broader quality system. Validation We use a validation master plan (VMP) to help you document a complex and dynamic system. There are many strategies, and we customize yours. Data Integrity It’s important to have a functioning quality assurance system in place so your company can comply with the FDA. We help organize and implement that system. Software Qualification At ASI, we require our clients to have their computerized systems qualified or validated. Our method is based on GAMP5 and provides a pragmatic approach. Auditing and Assessment We provide auditing services including vendor audits and mock FDA pre-approval inspections. Our goal is to help you reach your FDA compliance goals. Project Management Increase quality of projects with enhanced project management by documenting, reviewing, updating, reporting, and communicating throughout the process. We Only Provide High-Quality Products to Our Clients Meet FDA Compliance Goals Ask About Your Options Corporate Headquarters (847) 735-8310 11 North Skokie Highway, Suite 115 Lake Bluff, IL 60044 Email Us Southeast Regional Office (813) 281-4675 3001 N. Rocky Point Drive East, Suite 200 Tampa, FL 33607 Email Us © 2021 ASI Systems Engineering. All Rights Reserved. Call Today - (844) HIRE-ASI