Only so much activity fits into a work week. Pressing deadlines, critical projects, and a growing list of priorities can make it difficult to complete everything that needs to get done. Introducing changes adds new layers of complexity to the mix.

But fear not. Managing change throughout your organization does not need to be stressful. Having the right processes and tools can help. Let’s take a look at some of the top challenges and how to beat them.

1) Managing multiple teams

In regulated environments including those in the Life Sciences, quality system requirements spark myriad touch points for documenting changes, investigations, root causes, and more. Part of these processes tie into actual documents—your standard operating procedures (SOPs), work instructions, policies, etc.—and part alludes to actual changes to the processes or products themselves.

A change management software solution designed for organizations like yours—medical devices manufacturers, pharmaceutical manufacturers, biologics and combination products developers—includes best-practice logic for managing multiple teams. Does your Quality team manage global quality throughout your organization? Do you have different regulatory teams in different countries? An effective solution for managing change contains the logic needed to easily assign the right teams to the right change processes at the right time.

2) Differentiating the needs of multiple sites

Does your organization operate across multiple sites? What if you uncover a reoccurring nonconformance or deviation and need to update your processes at two out of seven sites, based on the supplies they are receiving for a particular product? This challenge can cause chaos if you are ill-equipped to manage/run your sites separately sometimes, and collaboratively at other times. With the right solution, you can easily identify which sites are affected by a change and either align them or separate them as needed.

3) Updating appropriate documents to align with changes

As we all know, documents are central to our processes, and we need them to be tightly controlled and appropriately reviewed. Additionally, we need to assure traceability by incorporating adequate audit trails. A highly-effective change management solution will keep all changes well-documented and transparent, particularly when it comes to documents and the content within.

4) Juggling multiple simultaneous changes

What do you do when a complaint comes in and leads you to identify an issue with your supplier? The changes start to feel like a domino effect: a corrective action preventive action (CAPA) is created, requiring an update to your specifications; now you might need to change your incoming materials and the inspection of those materials, designs need to be updated, and supplier oversight needs to be increased; your packaging and labeling need to be adjusted; who knows how many changes will result and how long it will take to make the adjustments? The way to overcome the challenge of managing multiple, varying changes, is through harmonized processes. Tracking every controlled change, assessing its impact, and effectively implementing changes consistently, every time, is the answer. You should also look for a system with simple, meaningful dashboard visibility into open tasks, and email alerts to keep everyone on track to complete his or her part of the process. These built-in best practices will help you solve this, and many change challenges.

5) Lacking visibility into your change processes

Just as dashboards and email alerts help with keeping your processes harmonized and consistent, they can also help solve the dilemma of losing sight of where you are. A well-planned change can take time to roll out throughout an organization, particularly in global environments. That’s why you need a centralized system for viewing open tasks, and which phase your change is in. Has QA not approved a change while the owning department has? With this knowledge at your disposal, you can follow-up sooner to ensure you’re making compliance-driven decisions to minimize risk in your organization.

6) Reversing a problematic or ineffective change

All the planning, prep work, and impact assessments in the world do not guarantee an effective result 100% of the time. Having a contingency plan keeps you prepared for unforeseen events. This can happen when implementing a new system, introducing new software, or simply modifying any of your processes. Hand-in-hand with managing changes, a solution that incorporates roll-back functionality helps you effectively plan, assess, and implement a roll back plan in any situation to reset your quality system or your environment to its prior state.

7) Quickly gaining appropriate approvals

There’s nothing worse than finishing something and waiting for approval so you can wrap up your project. This applies to implementing changes. Your organization may require an approval from the process owner and by QA. The right automated system will automatically route your tasks for the appropriate approvals, with rules and actions for overdue tasks and escalations. This helps keep everyone on track.

How will you overcome your challenges?

SmartSolve^®, from IQVIA, helps organizations like yours maintain efficient and compliant quality management systems. SmartSolve’s integrated platform provides a solution for overcoming the challenges of managing change, and further enables quality to become a centralized hub for continuous improvement throughout your business.

For additional information about this next generation QMS, download the fact sheet. Then, schedule a personalized discovery session with one of IQVIA’s QMS solution experts today. We'll review your current quality processes and show you how to get the most out of them using SmartSolve.