Process, Operator, Equipment, Materials Enforcement

Camstar Manufacturing enforces the as-designed process, ensuring the right procedures, operators, equipment and materials are being used, in the right sequence at the right time.

Electronic Enforcement and Control

Camstar’s electronic enforcement and control over global manufacturing processes helps remove manufacturing variability and costly reduce scrap, rework and non-conformances. Camstar’s Enterprise Platform is the only solution that: 

  • Automatically enforces adherence to the defined manufacturing process, and 
  • Ensures that corrective and preventive measures are effectively implemented, enforced and monitored to prevent reoccurrence. 

Camstar’s Enterprise Platform verifies all materials, operators, processes, parametric data, dates and times, electronic signatures, exceptions, resulting actions – globally. 

  • Operator training and certification are automatically checked before work can begin, as are equipment maintenance and calibration statuses. 
  • Electronic procedures and work instructions guide operators and ensure that all steps are performed in sequence and that required data is recorded. 
  • Equipment Preventive Maintenance (PM) optimizes scheduling and performance of primary and sub-tools based on time or usage. 
  • Electronic signatures are compliant with FDA Title 21 Part 11, and must be recorded before associated work can be shown as completed. 
  • Device, lot, batch or unit manufacturing history record (e.g., eDHR, eLHR, eBR) is automatically created and audited in real-time, providing full accountability, and facilitating product auto-release or exception-based-release. 
  • Compliance to GMP and other standards is a natural outcome of the enforced Good Manufacturing Processes.