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
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.
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
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
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 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.
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.
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.
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.
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.
What is the difference between change control management and change management solution?
No matter what industry you work in, change happens everywhere. To accomplish and track these changes, organizations use change management and change control correspondingly. Even though change management and change control share similarities, they refer to two different processes.
Change control is a specific element of the overall change management procedure; while change management refers to the complete span of a particular change procedure. Change control explains the consideration and approval processes that determine whether a particular change will occur within a given organization or not.
- Change Management:
Change management is an essential element of all organizations, a systematic process of enacting and tracking change within an organization. However, it is especially important in manufacturing and healthcare industries with precise and regulated processes. Every organization should have its own change management procedure depending on what sort of industry you work in, what kinds of processes your organization operates daily, and what sorts of standards and regulations are applicable. Irrespective of the industry, there are a few standard elements to a good change management process, including:
- Detecting the problem at the root of the change
- Reporting a change request
- Getting approval from stakeholders
- Implementing a strategy to enact the change
- Monitoring the success of the change once it has been implemented
- Change Control:
Change control is a distinct concept, the process of evaluating suggested changes and determining whether they should be enacted within the organization or not. The change control process is the best way to prevent organizations from facing too many unnecessary changes ensuring that each approved change will be valuable and worth the effort of integration.
Why is CQ best for Change Control Management?
CQ Change 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.
Frequently Asked Questions
What is a Change Management Solution?
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.
What is the importance of Change Control Management?
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 the product safety or quality.