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Industry: Medical Devices

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.