Managing the Impact of eClinical System Updates
Many of us use cloud-based clinical systems that regularly release system updates. Sometimes these are optional updates and sometimes they are required. System updates do everything from fixing bugs to offering enhanced capabilities. Often organizations go through the motions of accepting these updates without considering the implication of these updates on their business processes. As part of a regulatory compliant change management, it is critical that each change be assessed from not only a systems impact, but also a process impact. When receiving a clinical system update it is important to consider the following questions related to your business processes.
Should I take the optional updates?
Organizations will often decline an optional system update because of the requirements to update supporting business process. This can be risky. System updates are often driven by advances in the industry or changes in regulatory requirements. When optional updates are repeatedly declined, organizations find themselves in situations where the system becomes outdated and then an update has a significant impact on the business. It is important to evaluate each change, both forced and optional, to adequately assess impact on operations. Periodically organizations benefit from retrospectively assessing updates that had been rejected to evaluate implementing these changes at that point will enhance the user experience.
Will the update impact current process?
Sometimes a simple change in the software can impact the process in a big way. It is important that the users understand the change and the potential impact this change will have on how the organization delivers the business. For example, adding a new functionality requires a process and rules for how that functionality is used. If you fail to establish a process and rules, then some users will create their own process and rules and the result will be a lack of standardization. Other users will not use the functionality because they are not aware of it or don’t understand the value of using it. This business process impact assessment should be a documented step within an organization’s change management procedure. Where a system change results in business process change it is important to evaluate the full impact across all business processes.
Does the process change impact existing business documents?
If the assessment indicates a change in process, then it is important that business documents that support this process are updated as well. Sometimes it is a minor business process update but does not require update to business documents. However. in many cases a change in business process results in a change to the business documents as well. These updated business documents should go through proper change control that includes user training.
How will business process and system changes be communicated to the users?
Whether there is a process change or simply a software change, people generally don’t like surprises. Once an organization is aware of the upcoming system change and has assessed the impact of the change, it is important that this change is communicated to users. If the impact is significant, then users will benefit from hearing that there is a change on the way. Any significant change impacting the user should be communicated in the form of documented training. This training can be a read and understand communication, a webinar demonstrating the change within the system, or live training. The impact of the change should help determine the type of training to best ensure user success.
Just in Time GCP is a leader in clinical system business and technology consulting. We have significant experience in leading organizations through process optimization to support the evolution of business technology in their organization. If you have found your organization rejecting optional updates or failing to modify business processes to support software updates, we can help you in evaluating your current technology and process environment. We will then support you in an optimization project that closes identified gaps. Please reach out to us at info@justintimegcp to find out how we partner with our clients in supporting these efforts.
Written by Donna W. Dorozinsky, President & CEO