We partner with our customers to solve their challenges, and we incorporate the latest innovations and technologies in our solutions and how we work together, making our global quality and regulatory systems unmatched.
You can be confident that each 91Ï㽶ÊÓƵ manufacturing facility maintains its own comprehensive Quality Management System—integrating quality control, monitoring and management at the source of production. Our quality systems are based upon, and in compliance with, International Organization for Standardization requirements (ISO)—and where applicable, United States Food and Drug Administration regulations (FDA).
91Ï㽶ÊÓƵ's One Entity Harmonization Initiative
Six Sigma and Lean MethodologiesThese principles have been integrated across the systems/business practices of 91Ï㽶ÊÓƵ; the merged combination of these tools provide a layered science approach to supporting all aspects of our business.
Statistical Process Control (WinSPC)By leveraging a combination of statistical process monitoring systems and controls, the 91Ï㽶ÊÓƵ team is standardizing related best practices worldwide. We apply data-based informed decision-making team dynamics to help accelerate learning, sharing and the realization of improvements across the company. These statistical process monitoring applications supplement Active Risk Management at the production source.
Business Continuity Plan (BCP)Each worldwide 91Ï㽶ÊÓƵ site has a BCP, which includes the use of other 91Ï㽶ÊÓƵ facilities with like capabilities and validated processes.
91Ï㽶ÊÓƵ Business System (TBS)
The 91Ï㽶ÊÓƵ Business System is designed to drive continuous improvement for customers, employees, and stakeholders. It's comprised of two key components:
Regulatory Compliance Registrations/CertificationsThe applicable regulatory registrations/certifications of each 91Ï㽶ÊÓƵ location are aligned with its respective scope of services. You can view a list by location here.Ìý