Business Details
37 Years
experience
Your Partner for FDA Compliance & Systems Automation Solutions
Since 1989, Automated Systems has been a trusted leader in delivering FDA compliance, systems automation, and technical staffing solutions to highly regulated industries. Our team combines decades of experience in life sciences, pharmaceutical, and medical device sectors with specialized expertise in plant automation, data analytics, and quality systems consulting. With professionals averaging 10-15 years of industry experience, we provide tailored strategies for risk management, data integrity, and software qualification. Our nationwide services include PLC programming, HMI/SCADA integration, and manufacturing execution systems (MES) implementation. We maintain rigorous compliance with FDA and international standards through auditing, gap assessments, and validation master plans.Our commitment to technical excellence is supported by dedicated management teams and continuous employee training in cGMP and consulting best practices. By combining automation expertise with regulatory knowledge, we help clients achieve operational efficiency while meeting compliance requirements. Our track record spans 35 years of delivering project management, technology transfer, and infrastructure testing services to global clients. Our validated solutions cover product serialization, energy monitoring programs, and real-time performance analytics across life sciences and parcel handling industries. With corporate headquarters in Lake Bluff, IL, and regional offices nationwide, we remain dedicated to solving complex technical challenges through innovation and expertise.
Services
FDA Compliance Services
Systems Automation
Data Analytics
Technical Staffing
Plant Automation
Product Serialization
Validation Services
Quality Systems Consulting
Risk Management
Software Qualification
Details
- Year established: 1989
Highlights and features
- Dedicated professionals with 10-15 years of industry experience
- Customized FDA compliance strategies for life sciences sectors
- Integrated systems automation solutions for pharmaceutical manufacturing
- Nationwide technical staffing services across regulated industries
- Proven track record since 1989 in validated system implementation
Services
FDA Compliance Services
Our FDA compliance experts implement strategies for data integrity, risk management, and software qualification. We provide validation master plans, gap assessments, and auditing services to ensure adherence to FDA and international standards. With specialized knowledge in GAMP5 and quality systems consulting, we help pharmaceutical and medical device companies maintain regulatory compliance through remediation efforts and mock FDA inspections.
Systems Automation
We deliver automated solutions for manufacturing processes including PLC programming, HMI/SCADA integration, and MES implementation. Our automation services optimize production efficiency through network design, infrastructure testing, and DCS systems integration. Specializing in life sciences applications, we provide validated control systems for facility engineering and equipment validation projects across pharmaceutical and biotech industries.
Data Analytics
Our data analytics services create unified visualization platforms for manufacturing performance monitoring. We implement real-time dashboards, energy efficiency systems, and production data collection solutions. Using industry-leading historians and OEE reporting tools, we help clients improve asset utilization and operational efficiency through predictive analysis and process data storage systems.
Technical Staffing
We provide highly qualified professionals for project management, software development, and quality assurance roles. Our technical staffing services cover validation, automation, and facility engineering needs with experts averaging 10-15 years of experience. Specializing in life sciences sectors, we supply trained personnel for short-term assignments or long-term project support across pharmaceutical, diagnostic, and medical device companies.
Quality Systems Consulting
Our consulting services help clients build comprehensive quality management systems integrated with risk management frameworks. We provide technical writing support, gap analysis assessments, and remediation strategies for FDA compliance. Through customized validation approaches and audit preparation services, we ensure quality systems meet regulatory requirements while supporting operational excellence in pharmaceutical manufacturing.
Questions
What industries does ASI Systems Engineering serve?
We specialize in life sciences industries including pharmaceutical, biotech, medical device, and diagnostic companies, as well as serving packaging, parcel handling, and OEM machinery sectors.
How does ASI approach FDA compliance solutions?
We combine regulatory expertise with technical implementation through validation master plans, data integrity strategies, and risk-based qualification approaches aligned with FDA and international standards.
What automation services are available?
Our automation solutions include PLC programming, HMI/SCADA integration, MES implementation, network design, and infrastructure testing tailored for life sciences manufacturing environments.
What staffing expertise does ASI provide?
We supply technical professionals with 10-15 years of experience in validation, automation, quality assurance, and project management across regulated industries.
How long has ASI been in business?
We've been serving clients nationally since our founding in 1989 through three specialized groups focusing on compliance, automation, and technical staffing solutions.
What data analytics capabilities do you offer?
We implement real-time dashboards, process data historians, and energy monitoring systems to improve manufacturing productivity through predictive analytics and OEE reporting tools.
