quality systems and regulatory compliance

Quality Systems and Regulatory Compliance

The Adhesives Research (AR) and ARx, LLC divisions are dedicated to delivering the highest possible quality and reliability in the design, manufacture and delivery of products and services. Each division is guided by the appropriate quality systems relevant to the products they manufacture, regulatory requirements, and industries they serve.

The AR Quality System is driven by ISO 9001-2015 and ISO 13485-2016 certifications plus certain elements of the FDA pharmaceutical requirements.

The system operates with these functions:

  • QA (Quality Assurance)
    • Document control, final product release
    • Non-conforming material control, change control, CAPA and¬†audits, Quality Certifications,¬†Customer Requirements Review
  • QC (Quality Control)
    • Incoming, in-process and final product testing
  • QE (Quality Engineering)
    • Developmental and ongoing product support
  • Supplier QA
    • Raw material control and testing
    • Supplier relations and audits
  • Metrology

ISO 9001 Certification

ISO 13485 Certification

The ARx facility is registered with the FDA and operates under the cGMP regulations outlined by 21 CFR 211. They are solely focused on pharmaceutical applications involving active pharmaceutical ingredients (APIs).