Quality & Validation Management

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.