Change Control Management Solution

Change Control Management Solution

Optimize your organization’s Change Control Management to ensure continued compliance with GMP and associated regulatory documentation by meeting business challenges and legal obligations.

A fundamental formula to succeed in the competitive life science business environment to drive innovation with speed.

Change Management Solution
Change Management Solution
Change Control Management video

What is Change Control Management Solution?

A change control management solution is a structured process to ensure that changes are introduced while minimizing disruptions and risks. With these solutions, organizations can plan, assess, and oversee changes to systems, processes, products, or projects. With this process, businesses can maintain the overall integrity and quality of the organization's operations.

This process includes requesting and evaluating changes, determining their feasibility and impact, obtaining approvals, implementing changes, and monitoring outcomes to maintain the integrity and quality of operations.

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What is the Change Control Management Plan?

Change control management system refers to the controlled set of actions to ensure that a change does not negatively impact a product’s safety, quality or compliance. The control may be proactive or reactive, as a response to mitigate or eliminate the consequences of unplanned change, also known as deviation.

The important features of change control include:

  • A plan that identifies actions, inputs, outputs and control limits to determine successful achievement of the desired change
  • A record of required elements of plan review combined with supporting data
  • Essential regulatory approvals for the changed state before the product made under the change is released in the market
  • Enforcement of any new or updated Good Manufacturing Practice (GMP) documentation and appropriate staff training

An integrated change control management can automate and streamline the entire change control process, from submission through resolution. A robust change control solution can link users and data via a centralized system and connect the change control process with other quality processes to boost continuous improvement.

Change Control Management plan

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Why is Change Management Solution essential?

Change management solution is a structured, determined approach aimed to transform people, teams, and organizations from their present state to the desired future state.

Change management solution is essential for below practices:

  • Eliminate ongoing failures during the change as an opportunity for learning and promote an organizational culture that supports it.

  • Stay open for discussion and don’t think to alter strategic direction during the change journey.

  • Reprocess technological and organizational-based learning from past experiences.

  • Harmonize the approach to change according to the design and the levels of experience, phases of learning and various activities of each unit.

  • Place change management on top of the executive agenda and develop tools, methods, roles, and skills for its execution.

  • Improve and increase the employee experience and positive customer experience.

  • Increase engagement and reduce costs.

  • Minimize resistance and enhance innovation.

Document, Training and Change

The Role of Change Management in Digital Transformation

What are the effective steps in Change Control Management?

In today’s world, organizations experience changes whether it is caused by new technology implementations, compliance initiatives, process updates, reorganization, or customer service improvements. Change is constant and required for growth and profitability. A change control management process will reduce the impact on your organization and employees.

Here are the essential steps to ensure your change initiative is successful:

identify the improvement

Identify the Improvement

It is crucial to identify the focus and to clarify goals to ensure that the changes improve a process, a product, or an outcome. Recognizing the resources will facilitate a smooth transition to the changes, providing a solid foundation that enables successful implementation.

plan for the change

Plan for the Change

This step is the “roadmap” that determines the beginning, the route to be taken, and the destination. Incorporate the resources to be leveraged, the objective and the costs into the plan. A vital element of planning is providing a multi-step process rather than sudden, unplanned changes by outlining the project with clear steps with measurable targets, incentives, measurements, and analysis.

provide resources for evaluation

Provide Resources and Use Data for Evaluation

In the planning process, resource selection and funding are very important elements, as also the tools needed for re-education, retraining, and rethinking priorities and practices. Many models identify data gathering and analysis. Clear reporting allows for better communication, proper distribution of incentives, and measuring business successes.

communication

Communication

Identifying, planning, onboarding, and executing a good Change Management depends on enhanced communication. Providing clear and open lines of communication throughout the process is an essential element in all change modalities that recommend transparency and two-way communication structures to provide ways to release frustrations or applaud what is working and change what doesn’t work.

monitor and manage resistance

Budgeting Risks, Monitor and Manage Resistance, Dependencies

Resistance appears when there is a good amount of risk associated with change. The risk could be of influencing dependencies, return on investment, and associated with allocating a budget that can threaten the success of a project. Anticipating and preparing for resistance by equipping the leadership with tools to manage will assist in a smooth change lifecycle.

revise and continuously improve

Review, Revise and Continuously Improve

Even though the change is difficult, it is also an ongoing process to identify and remove roadblocks. And, this process is only as good as the commitment to measurement and analysis such as resources and data.

  • identify the improvement

    Identify the improvement

    It is crucial to identify the focus and to clarify goals to ensure that the changes improve a process, a product, or an outcome. Recognizing the resources will facilitate a smooth transition to the changes, providing a solid foundation that enables successful implementation.

  • plan for the change

    Plan for the Change

    This step is the “roadmap” that determines the beginning, the route to be taken, and the destination. Incorporate the resources to be leveraged, the objective and the costs into the plan. A vital element of planning is providing a multi-step process rather than sudden, unplanned changes by outlining the project with clear steps with measurable targets, incentives, measurements, and analysis.

  • provide resources for evaluation

    Provide Resources and Use Data for Evaluation

    In the planning process, resource selection and funding are very important elements, as also the tools needed for re-education, retraining, and rethinking priorities and practices. Many models identify data gathering and analysis. Clear reporting allows for better communication, proper distribution of incentives, and measuring business successes.

  • communication

    Communication

    Identifying, planning, onboarding, and executing a good change management system depends on enhanced communication. Providing clear and open lines of communication throughout the process is an essential element in all change modalities that recommend transparency and two-way communication structures to provide ways to release frustrations or applaud what is working and change what doesn’t work.

  • monitor and manage resistance

    Budgeting Risks, Monitor and Manage Resistance, Dependencies

    Resistance appears when there is a good amount of risk associated with change. The risk could be of influencing dependencies, return on investment, and associated with allocating a budget that can threaten the success of a project. Anticipating and preparing for resistance by equipping the leadership with tools to manage will assist in a smooth change lifecycle.

  • revise and continuously improve

    Review, Revise and Continuously Improve

    Even though the change is difficult, it is also an ongoing process to identify and remove roadblocks. And, this process is only as good as the commitment to measurement and analysis such as resources and data.

Journey from Paper to Digital

Customer Success

Making the Journey from Paper to Digital is a Game Changer for Life Sciences Company

Journey from Paper to Digital
Read Case Study

ComplianceQuest delivers!

I’ve been using ComplianceQuest (CQ) for about 9 months and am extremely pleased with the product, the implementation team and ongoing support.

I selected CQ for a number of reasons. Functionality and a simple user interface were key requirements. CQ has all the functionality needed in support of a global QMS. Implementation includes; Document control, change order, personnel training, NC/CAPA, equipment management, supplier management, audit management, and customer complaints all on a single platform. As a small biologics company it was critical to find a single solution to meet our GMP quality system requirements. We wanted a cloud-based system, that would be quick to implement, that could be expanded globally and in other languages, all for a reasonable price. The user interface – it is exactly what I was hoping for. I constantly hear the staff saying, “I love CQ, it’s so straightforward to use”.

Donna Matuizek,
Sr. Director Quality

Just Logo
Just Logo

Why is CQ best for Change Control Management?

CQ Change Control Management links automatically with other QMS processes including CAPA, Document Management, and Training Management to ensure seamless integration between QMS processes. It not only ensures compliance by maintaining detailed documentation on all changes, such as those related to design specifications, SOPs, materials, suppliers, and processes but can also greatly increase your company’s productivity and customer satisfaction.

why CQ best for Change Control Management

Manage your entire change control management process with ComplianceQuest's Change Control Management for detecting, reporting, implementing, and monitoring the success of the change

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Frequently Asked Questions

  • Change management solution is a methodical approach to transitioning individuals, teams, and organizations from a current state to a desired future state. It can be applied to situations such as growing organizations, downsizing, or even adding new people or technology. It is an organizational process intended at helping employees to understand, commit, accept, and embrace changes in their current business environment.

  • In the life sciences industry change control management plays an important role. Life sciences companies must report every change when adding a new procedure or changing an existing procedure approved by appropriate authorities. A pharmaceutical company will make changes to any existing product after obtaining approval from the regulatory bodies by strictly adhering to the policies determined by regulatory authorities such as the US FDA and MHRA. Handling a change in pharmaceutical, biotech and life sciences companies is challenging if the process is paper-based. In a cGMP-regulated environment, regulatory guidelines monitoring has a tremendous impact on quality performance. Manual or paper-based change control systems have scope for human errors, undesired repetitions, lack of traceability and many other challenges which affect time. This can significantly impact productivity and eventually product safety or quality.

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