Regulatory affairs is constantly changing, and these changes span the entire product lifecycle - from pre-market awareness of global regulations to managing varying and changing market placement and post-market activities. Managing all types of regulatory changes without streamlined processes and methods in place is a daunting task and one that can set regulatory affairs teams up for risks, including project delays, non-compliances, financial impacts, and employee turnover.

With regulatory affairs interactions and activities often spanning various departments, office locations, and external stakeholders, many regulatory affairs teams are left wondering how they can better streamline their process management.

We recapped core methodologies from our recent webinar, Navigating regulatory change: Why streamlined process management is critical for medtech regulatory teams, to help RA teams review their existing processes, identify gaps, and put together a remediation and implementation plan that will enable them to reduce risks and maintain regulatory continuity.

Phase 1 – Assess your team’s current processes

Assigning resources to provide an honest assessment of your regulatory processes can be tough. We've seen the most success by having awareness and involvement from all of your team’s stakeholders, as many of them have a vested interest in your regulatory processes and information. Additionally, we've seen even greater success when those efforts are supported by an executive sponsor who's committed to streamlining these processes and making the changes.

When we talk about assessing current processes, we don’t just mean reading common SOPs and flow charts. We're talking about an honest review of the adequacy of your regulatory inputs. Some questions you can ask to help with your assessment are:  

• Do we have everything that we need when we need it?  
• Does this process generate valuable deliverables? How hard are we working to generate these outputs?  
• Do we have the right tools in place? If not, what tools on the market can help us achieve our goals?  

It’s safe to say you can spend less time on processes that you've identified are working well. If you don’t know exactly where to start in a process assessment, it's helpful to think about where you spend most of your time. When focusing on the processes that are taking up most of your time, it’s easier to see where the inefficiencies lie.  

Once the opportunities for improvement are identified, it's time to consider all potential risks. Compliance risk is an important thing to consider, but there’s also business risk with slow processes, inefficient processes, or even worse, ineffective processes where RA professionals spend a lot of time arriving at the wrong output or no output at all.  

As risk is assessed for these opportunities, you should then consider the effort that it's going to take to resolve each. This measurement doesn't have to be highly specific. The intent for it is to ultimately help you prioritize which regulatory process changes you want to execute with your team first.

Phase 2 – Planning for Improvement

While there is some planning that needs to take place at the time that you kick off the assessment phase to help you understand and establish who's going to assess which processes., this phase is intended to focus on planning for improvement. It starts with prioritizing your inefficient processes from highest to lowest. Gaps should be prioritized and resourced first without trying to “boil the ocean.” This will help your team set itself up for a successful implementation phase next. From our experience, it’s hard to appropriately focus on process improvement when trying to change too many processes at once.  

Within the planning phase, you can review the results of the assessments with all of the regulatory stakeholders and any other stakeholders who are involved with the outputs of the processes. The process owners can then take this opportunity to break down silos by understanding the relationship that their processes have with other departments and the effect their outputs have on these departments. Taking the time to understand the impact your processes have on other departments will allow you to be able to make any necessary adjustments to the inputs and outputs of your processes and hone your communication strategies.  

From here, you can assign resources and tasks to manage the overall effort with regular check-ins.  

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Phase 3 – Implementation  

Implementation, the easy part as we jokingly say. As you work through the implementation tasks identified in the planning phase and check in with your stakeholders, it's a good idea to test and iterate on your changes to ensure that they continue to make sense. This is also crucial to verify that your changes are advancing the project or the task toward your overall process management goals.

Training is a key element in the implementation phase as well. Any upfront communication that can be provided to the users of the process ahead of the training is going to be beneficial for change adoption and change management. It’s important to not only communicate that  process changes are coming but also why they are coming and what benefits the end users of the process and the consumers of the outputs expect to see as a result.

Once those process changes have been implemented, and training is completed, it’s important to measure and monitor the process for the effectiveness of the changes. Some key questions to consider here are:  

• Did we gain efficiencies?  
• Did we make our lives easier with these process changes?  
• What impact have these process changes had on our team, other departments, and our organization?  

If you can’t answer these questions positively, it’s important to go back through the assessment planning phase activities to make sure all improvement opportunities and tasks were properly identified and assigned. When you’ve found those changes have made a positive impact, you should communicate those successes with all relevant teams to build a success story within your organization and to encourage additional adoption of these changes.  

Our webinar replay, Navigating regulatory change: Why streamlined process management is critical for medtech regulatory teams, has more tips to help you optimize your process management and explains how regulatory tools such as RIM systems can help RA teams automate, track, and manage their processes across global internal and external teams. Download the full replay here.  

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