McDougall's Commitment to Quality

McDougall's Quality System (QS) is a risk management-based approach. Understanding and mitigating hazards and risks is at the core of our commitment to quality services.

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. Pre-defined quality assurance checkpoints are performed by the Quality System Manager, who verifies the execution of tasks against the SOPs and work instructions.

The business processes are also based on published regulatory requirements and guidelines (e.g. ICH GCP, GCDMP, 21CFR11 and predicate rules, GAMP5, and relevant IEEE standards). McDougall warrants that computer systems are validated and kept in compliance with these requirements. All systems and applications adhere to the principles of a Systems Development Lifecycle (SDLC).

McDougall's entire computing infrastructure is supported by a comprehensive business continuity (BC) plan that encompasses disaster prevention and recovery. The BC plan, developed by the resident Business Resilience Specialist (certified by the Business Resilience Certification Consortium International), undergoes scheduled reviews, maintenance and testing.

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