McDougall's Commitment to Quality

McDougall's Quality System is based on a risk assessment approach and is documented in the company's Quality Management Plan. Understanding and mitigating hazards and risks is at the core of our commitment to quality services.

The business processes adhere to published regulatory requirements and guidelines (e.g. ICH GCP, GCDMP, FDA 21CFR11 and predicate rules). For each business process, we maintain a process description, flowchart, and risk analysis. The mitigation strategies for identified hazards to quality are mapped to steps in the supporting SOPs (Standard Operating Procedures) and work instructions. McDougall staff receive appropriate SOP training which is tracked through a state-of-the-art computerized system.

McDougall warrants that computer systems are developed, validated and kept in compliance with regulatory requirements. All systems and applications adhere to the principles of a Systems Development Lifecycle.

McDougall's computing infrastructure is housed in a Tier 3 collocation facility and is covered by a comprehensive business continuity plan that encompasses disaster preparedness and recovery.

Contact us to find out more about our Quality System.