Life sciences: IT quality management system (QMS)

IT quality management system (QMS): international biopharmaceuticals provider

Challenge:

Over time there was a proliferation of redundant and inconsistent quality and validation procedures and processes, leading to confusion and increased risk that the company would not be able to effectively demonstrate regulatory compliance. Our client needed to develop and implement a global IT Quality Management System (QMS) that would:

  • Ensure all IT quality and compliance activities were risk-based and balanced
  • Drive consistency and quality in the development and implementation of all computerized systems
  • Ensure the company could effectively and efficiently demonstrate compliance with applicable laws and regulations
  • Integrate and align with the overarching company quality assurance and compliance strategies and objectives

Solution:

Mazars USA worked with the our client’s IT Quality and Compliance and Quality Assurance functions, along with various operations groups to develop and implement a company-wide IT Quality Management Framework and strategy. Integrity facilitated strategy and working sessions across all stakeholder groups and managed a phased implementation of the key quality foundational components including:

  • Obtaining cross-functional executive buy-in on the IT Quality vision and framework
  • Establishing a Quality Agreement
  • Developing and rolling-out key Standard Operating Procedures and supporting templates/forms
  • Implementing an integrated and comprehensive training and awareness program

Results:

The Mazars USA team was able to drive the development and implementation of a new IT QMS that:

  • Established clear, unambiguous roles and responsibilities for IT quality and validation activities
  • Promoted a risk based approach to quality and compliance activities
  • Ensures consistency in the development and implementation of all computerized systems that promotes quality and that will allow the company to effectively and efficiently demonstrate compliance with applicable laws and regulations
  • Effectively integrated IT quality and compliance with interdependent corporate functions
  • Facilitated a significant culture change, promoting collaboration and breaking down silos between IT, QA and operations