One of the largest challenges for deployment of an enterprise-level calibration management program is to provide enough flexibility in the workflow to accommodate regional needs while also establishing a common structure consistent with corporate objectives. This is best exemplified when working in a highly regulated environment, where all sites may be forced to follow the most stringent rules set by the most regulated locations if they plan to take advantage of the benefits that come with a centralized system. In some cases, corporate management may see this as a strength, expecting that the additional forced regulation for some will minimize the overall risks for non-compliance. In reality, many of the actual users that interact with the program daily will see this as unnecessary friction being added to the process, ultimately hurting productivity & ROI.
The freedom to function independently of other sites is vital for large-scale deployments, especially amongst regulated industries. As a real-world example, one of our clients recently installed our CMS across 14 sites and all information was encapsulated within a centralized database. Each of those sites had established their own unique, autonomous account, though all accounts were globally managed by a single super user. The requirements for each site varied greatly, from a full production location with critical equipment to an R&D site that allowed for more flexibility in its processes. With the ability to set a unique regional configuration & workflow, end-users and management alike were able to fine-tune their system to ensure a high degree of user satisfaction, minimal operational friction and yet still maintain their individual level of required regulatory compliance. This was not only vital for end-user adoption of the system, but it ultimately ensured that each site was performing at peak productivity.
When harmonization is key, certain companies will decide that a universal configuration and workflow is an ideal situation. We have seen this as a popular option amongst companies that function in industries with lighter regulatory requirements, as well as those that would like to ensure, from a corporate management level, that all locations are functioning in a specific and approved manner. This approach is also frequently taken by those that wish to have a single-validated Performance Qualification across all their locations. While there might not be as much site flexibility at this level, the benefits of higher-level direction are popular for those looking to save time and resources on the initial deployment.
Regardless of the path that your organization decides to take, the freedom to decide whether all sites will adhere to harmonized practices, or develop their own localized workflows, brings an important question to the forefront of the deployment. Both options have their benefits, though one very well may integrate better within your organization. When considering this, it is important to not only understand the measurable outputs from either approach (such as productivity and cost-savings) but also the results that are more difficult to quantify (for instance end-user buy-in and local variables). Regardless of the option that better suits your organization, our team stands ready to assist with your planning and results objectives.