Best Practices Projects (paper-based):

  • Manufacturing process improvement projects including Lean Manufacturing, Kanban systems, etc.
  • Document/data management system projects including document and change controls, data controls, engineering changes
  • Manufacturing execution systems
  • Complaint Handling systems
  • Supplier Qualification programs
  • CAPA and Nonconformance Programs
  • Post-Market Surveillance programs

Best Practices Projects (software-based):

  • Electronic system programs (eDMS, MES, ERP, training databases, etc.) from concept through monitoring phase.
  • Any software-related project from corporation-wide ERP systems down to local level of electronic manufacturing or change control systems
  • Develop concept and system requirements
  • Identify CTQ Customer Requirements, identify potential solutions, pilot solutions, and roll-out final solution
  • Work with vendor/supplier of electronic system to manage system customizations to your specifications
  • Provide Software Quality experts that write, perform, and report software test protocols and reports for software validation purposes
  • Work with vendor/supplier to develop training materials and then can lead client training to any level needed (site-wide to one-on-one).
  • Provides full roll-out of software solution including Road Shows to all key stakeholders
  • Establish processes and controls for the continued use of the software solution into the future including bug reports, customization, and requests for future enhancements

Neozene, as your Process Improvement partner can help you answer the following questions:

  1. Which technological solution is best for my document control system or supply chain?
  2. What is post-market surveillance, exactly and why do I need to do it?
  3. How do I determine which complaints are reportable and which are not?
  4. Do I have to perform supplier audits?
  5. I have a lot of manual processes in manufacturing. How can I create processes that are not so subject to human error?
  6. How do I validate my software that is used in the manufacturing process?
  7. When do I need to validate my software?
  8. Who says that I have to close CAPAs within 30 days and why do they say this?