ASI can help manage, automate, and validate innovative life science technologies. We are a group of professionals who specialize in FDA compliance and process automation for manufacturers regulated by the FDA. ASI’s large staff of engineering, life science, and computer science professionals, all of whom possess cGMP regulated industry experience, bring to life creative and compliant pharmaceutical, medical device, biotech, and API manufacturing solutions.
- ASI's FDA compliance staff has experience with equipment, facility, utility, computer hardware/software, process, cleaning, and test method validation/qualification in environments ranging from bulk chemical manufacturing to aseptic filling.
- Data Integrity Assessments and Solutions
- Product Serialization and e-Pedigree Solutions
- Advanced proficiency with PLC, HMI, SCADA, and DCS design, development, and systems integration.
- Well versed in Quality Systems
- Full Lifecycle Software Development
- 21 CFR Part 11 Expertise