Validation

Synertec's areas of expertise include:

  • Analytical Method Validation
  • Cleaning Validation
  • Computer System Validation
  • Design Qualification
  • Equipment Validation
  • Final Product Testing
  • GMP Principles
  • Installation Qualification
  • Operational Qualification
  • Performance Qualification
  • Process Qualification
  • Raw Materials Specifications
  • Risk Assessment
  • Validation Master Plans
» Automation & Electrical 
» Compliance
» Construction
» Manufacturing
» Process & Mechanical Engineering
» Project Management
» Training & Outsourced Professionals
» Validation

Medical Device Manufacturer,
Australia

The project was to develop and implement a software application to automate existing paper-based systems used in the management and tracking of a number of QA processes. The new system was to include the use of electronic signatures, electronic records and system audit trails.