Whether you are in regulated industry or not a sound quality management system QMS based on ISO (international standards) will ensure your business has a systematic and documented method for ensuring business continuity. The extended requirements for regulated industries such as Pharmaceuticals is that they have documentary evidence to support there business operations based on a risk based approach.

A strong emphasis on Validation, with

  • Requirements planning
  • Risk based validation strategy planning
  • Validation policy
  • Validation master plan
  • Steering Committee
  • Definition of responsibilities
  • Standard operating procedures (SOPs)
  • Documentation
  • Change management
  • Maintenance of the validated state
  • Periodic reviews
  • Record Integrity
  • Appropriate training where a need is identified.