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A California-based biopharmaceutical company that designs and develops off-the-shelf Gamma Delta T-cell therapy to treat cancer (and other diseases) is advancing a pipeline of innovative immune-cell therapies. As with many early-stage life sciences organizations, the company relied heavily on paper-based and document-centric quality processes.

The company was tracking documents using spreadsheets and found managing revisions, changes, and approvals difficult. The potential for human error or misplaced information created gaps in the control loop.

The company implemented ComplianceQuest EQMS and this has certainly made life easier for the quality team. The overall process of document management, MoC (management of change), and the end-to-end QMS workflow have all become digital. Additionally, with an integrated risk management solution in place, quality, design, and engineering leaders are able to assess the potential impact of a change on other business processes, making it a truly connected system.


In another instance, a leading manufacturer of hurricane-resistant windows and doors with over 3,200 employees – was struggling with an “Excel and e-mail based” QMS workflow.

With a manual, non-automated QMS system, quality leaders at the company were finding it extremely difficult to track, monitor, and manage changes. Whether it was a product or process-related change, it was getting complicated to make sure that the change was effective, or whether it induced any new risks into the product lifecycle.

The company then implemented ComplianceQuest EQMS and has since experienced vast improvements in Change Management and CAPA efforts. The integrated modules work together synergistically, increasing transparency and ensuring accountability within quality processes.

There is greater visibility, communication, and efficiency between each department. The team can work together seamlessly to assess risks, perform root cause analysis, manage investigations, create action plans, and conduct reviews and grant approvals.

Management of Change has Become a Core Aspect of Quality Management

In the modern, post-Covid world, change management has assumed greater significance, as pointed out by HBR. In the last year or so, businesses have seen greater disruption than in the last nine years. They are having to change their business processes with higher stakes and a need for faster adoption to survive and grow.

In such a scenario, traditional change management processes that are heavy, time consuming, and costly cannot help businesses become agile in implementing the changes. These changes range from introducing new product and service portfolios, reinventing supply chains, and pursuing large-scale restructuring of the organization for improving operational efficiency and transforming businesses effectively.

But, managing the changes and implementing them effectively is not a straightforward task. Some of the common challenges in this include –

  • Poor understanding of the need for change management
  • Organizational resistance to new ways of working
  • Introducing many changes parallelly
  • Pace without visibility
  • Insufficient communication of the changes, responsibilities, and benefits
  • Risks induced by a change

Critical Factors for Successful Change Management

For effective change management, it is important to have a champion for the change right at the beginning. Effective communication to notify all relevant teams of the intended change along with the impact and benefits for their areas of responsibility, top management commitment, and early wins are some of the critical factors that enable the change to be implemented effectively.

Establish a Business Case for the Change: A change must be seen to add value to a process or product or service. Communicating the change and creating awareness for clarity and getting the buy-in of the employees are essential for effective change management.

Leadership Commitment: For the successful implementation of the change, top management commitment and involvement are very important. This will percolate down the hierarchy and increase employee engagement in the change management process.

Employee Engagement: Empowering employees with tools and technologies to be proactive in introducing and managing the change is important. This will help improve commitment, embrace changes, and enhance skills.

Assign Ownership: Assign clear responsibilities to middle and front-line managers for the changes being implemented in their functional areas. This will help them show by example and facilitate a smooth change.

Incentivize or Reinforce Positive Behavior: Providing support to those who successfully implement changes, rewarding them, and sharing their contribution with the rest of the organization can motivate the person to do better and others to follow the example more diligently.

Data-driven, Collaborative, and Integrated Change Management with CQ EQMS

The ComplianceQuest Change Management software is cloud-based and provides teams across the organization and even in different locations with visibility and transparency . It helps with standardizing communication, while also streamlining the entire process and workflow, including sharing relevant information, data, and documents.

Further, the Change Management software seamlessly integrates with other modules such as CAPA, Document Management, Training, and Risk Management. CAPA helps to trigger any corrective and/or preventive action to be taken in case of any events due to the change.

Documentation is an important part of change management and also a regulatory requirement. By automating document management, the document lifecycle from creation to archiving becomes easier.

Identifying gaps and upskilling employees to meet the new needs following the changes also becomes possible. Training can be scheduled, reminders sent, employees assessed to make sure they have taken the course and assessing performance are some of the benefits.

Risk Management is a critical part of change management as it helps with identifying and prioritizing risks and determining the course of action to be taken.

Management Review is another key component of change management. It provides the management team with data to make informed decisions, assess and monitor progress, and assign roles and responsibilities.

A supplier management system helps to ensure the suppliers are aware of the changes and the action to be taken at their end to meet the new demands. The complaints module also helps identify the changes required and respond in a timely and appropriate manner to retain customer loyalty.

CQ Change Management Solution includes the following features –

  • Change Initiation
  • Change Evaluation
  • Change Execution and Tracking
  • Change Verification and Closure
  • Change Control with a risk-aware approach
  • Access to data and analytics to make change decisions
  • Ease of collaboration with multiple stakeholders

To know more about the ComplianceQuest Change Management software, visit: https://www.compliancequest.com/change-management-software-system/