Industry: Medical Devices
Service: Quality Assurance
Background The company had experienced substantial growth through the acquisition of numerous medical device and pharmaceutical operations over the previous ten years.
Business Issue With a large diversity in medical products and services and a global presence, the company had encountered increased regulatory pressure and organizational challenges for managing computer technology.
The Objective Establish a corporate computer system quality policy and related procedures to ensure compliance across the corporation.
The Solution Along with the company's executive management, Arbour Group defined a quality system architecture. Working with quality compliance, IT and major system owners (e.g., QC laboratory, engineering, R&D, manufacturing and quality control), Arbour Group developed a computer system master compliance plan and the following corporate policies and procedures:
- Computer Validation Policy
- Special Uses Policy
- Legacy System Remediation Procedure
- New System Implementation and Validation
- Quality System Change Control
- Network Configuration and Change Control
The master compliance plan identified corporate expectations for implementing a divisional rollout of this quality system. Major components included training (overview and skills-based), technical assistance, quarterly progress reporting and compliance monitoring.