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Change management: 7 steps to a streamlined transition

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Change is essential for growth, no matter which sector your company or organization excels in. However, change can also be a trying period in any company if you and your team don't take the necessary steps to prepare for it. To help set you up for a successful transition, we’ve put together a list of 7 steps you and your team should consider thoroughly before embarking upon the change journey.

 

1. Identify Your Reason for Change

Why do you want to implement change in your organization? This is the first step in the transition process. Maybe you want to offer new services or products. Perhaps you'd like to streamline your operation to make it more convenient for your customers, or you're using older technology and want to transition to newer software and hardware. Maybe a crucial new regulation or ISO requirement is imminent and will affect your organization. Whatever the reason, make sure you clearly identify it.

 

2. Take Note of Any Industry Regulations

Regulated industries like pharma, biotech, and medical devices require additional research and planning when it comes to organizational change. You have to consider so many more legalities, and you have to take note of any special rules or regulations that govern what you can and can't do. You want to keep these on hand throughout the transition to ensure that your organization doesn't experience any legal setbacks. 

 

3. Perform a Risk and Impact Assessment

It's essential that you know the risks and impacts of any type of change that you want to make in your organization to ensure that your changes are going to improve your processes or products and extend your organization's relevance and longevity. This assessment can help you start to define which goals are going to work best for your organization, and it can get everyone on the same page. There are a variety of risk assessment tools available that can help greatly with this step.

 

4. Get a Cost Estimate

Once you identify your reasons for the change or transition, start searching around to get a cost estimate. This will help you get a clear picture of what your organization can and can't afford, and you'll also learn about alternatives to help you achieve your goals.

 

Did you know Scilife has a dedicated module to help life science companies handle change? Find out more about our Change Control module here!

 

5. Implement Change Control

You want to implement change control to keep your organization on track throughout the transition. Change control can help to ensure that your organization doesn't make a lot of unnecessary changes, that everything gets documented, that you use your resources efficiently, and that you experience no unnatural disruptions in your day-to-day operations.

Once your organization decides to go ahead with the change and the change control is approved after having completed the first four steps (reason, regulations, risk assessment & cost analysis), you should create a comprehensive Change Control Action Plan.  

 

6. Generate your Action Plan

An action plan describes the steps you intend to take before and after the change. In order to provide the conditions for implementation before implementing change, you need to take several actions. Then, after the implementation, there are Quality Assurance (QA) and Quality Control (QC) actions that must be taken. Before you’re able to implement the change officially, you might need to take one or more of the following actions: validation, verification, qualification (such as Design (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Perfomance Qualification PQ)).

 

7. Set up  Quality Assurance

Once you have clear goals, you can start setting up processes to ensure that your organization maintains the same level of quality throughout (and after) the transition period. Ideally, you want to improve your organization's quality assurance, but it's more important to monitor it during the transition period and work to keep it up to your standards. This could include setting goals, identifying your success factors, implementing electronic signatures for your employees, listening to your customers, and taking steps like additional training or correcting your processes to streamline them.

 

Make change simple
with Scilife

Ready for change, about to start a transition, or already in the middle of it? Our  Change Control module not only helps you to monitor and implement a simple and solid quality assurance process for change, it also gives you an incredibly powerful tool that can help you maintain that process of change and make small but vital continuous improvements

Our Change Control module is just one out of an array of useful Quality Management modules that you can pick and choose from to build your Scilife; your all-in-one life sciences management platform! To learn more, get in touch.

The requirements of Life Sciences companies (including in the pharma and medical device space) inevitably change over time. Sometimes, a change is due to regulatory requirements; sometimes, customer needs change. Keep reading if you want to...