More labels to manage, more changes requested, expansion into new markets, more and more versions of files to track; does this sound familiar?
How about lack of visibility into your E2E labeling process or logging in and out of multiple systems each day to manage labeling information?
I had the opportunity to attend and speak at the Pharma Packaging and Labeling Conference in Philadelphia, PA back in March. Companies at the event ranged from those with one or two products in clinical trials to top 50 pharmaceutical organizations. While the wide variety of attendees brought many different points of view, they also shared many common challenges.
One reoccurring theme this year at the show was End-to-End labeling, or more specifically, how to gain visibility into the E2E labeling process. Without this visibility, it can be difficult to make smart business decisions when changes are required, resulting in loss of productivity.
In my presentation, “Behind the Scenes of E2E Labeling,” I talked about a typical current state for the process, how it is improving and what the future may hold. Read on to learn more about what I covered in my presentation and some tips you can use to get started on improving your current process.
The Current State of E2E Labeling
Today, it is tough to gain visibility into the E2E labeling process. Many factors make this a challenge:
- The volume of content from the Core Data Sheet (CDS) to Patient Information to product information to the Instructions For Use (IFU) or User Guide, to the label or carton, is very unmanageable
- The relationships between a change request, the impacted CCDSs, the local market impact, and the SKUs and components affected
- The number of people involved in the process, from quality to regulatory to artwork design to supply chain, and all of these potentially in multiple countries or regions
- The complex technology infrastructure that supports the E2E labeling process
E2E labeling is messy and different at each organization. However, it is common to see a company use the following E2E process:
Often when I talk to customers, they claim they find:
- Change Control
- Product Registration
- Document Management
- Bill of Materials Management
- Specification Management
- Health Authority Submission
- Regulatory Information Management
- Artwork Management
- Supply Chain Management
A company may have more than one of each of these systems, either due to regional differences or legacy systems from an acquisition or simply because there is decentralized sponsorship of operations in the business; it’s not unusual to see upwards of 20 instances/versions of SAP running in a global organization.
With this complex supporting infrastructure, when someone in the company wants consistent E2E visibility, there is no one place to get it, and it ends up being a manual effort to populate Excel spreadsheets with data collected from multiple systems. Manually filling and managing spreadsheets is an enormous effort and as soon as it is created, it is often outdated. With this type of knowledge, many companies realize they need to improve their current state with appropriate technologies.
The Evolving E2E Technology Landscape
Some companies may already have started this journey with system consolidation or integrations, and solution providers are continuing to improve their solutions to meet this growing demand for better visibility. I’ve used the following three categories to describe what Esko is currently seeing in the marketplace:
- Global System Standards
Global System Standards
Global system standards (GSS) are driven by global process harmonization, and for the most part, life sciences companies are pretty good at implementing GSS.
Years ago, regions may have selected different tools for the same function because the tools were not mature enough to handle regional variations, but now most Enterprise applications can accommodate global usage. But even with a consistent global infrastructure, when an acquisition takes place, there are different SOPs and different supporting technologies that need to be combined and rationalized.
E2E visibility implies that a company has views into all of this data and can use it to analyze and report results. Data Warehousing has been a common reporting approach for many years and lets us create real-time bar charts and other graphical views of the data. Warehousing requires data modeling and “denormalizing” data, effectively organizing the data in a way that lets the user more easily get the metrics that are important to them. This denormalization is both good and bad.
One benefit of data warehousing is that it dramatically reduces the end user’s need to understand complex data models from all of the source systems, because the data is structured, or “denormalized.” The downside is that the data models are built based on what types of reports you want today. If your future needs change, it may require a change to the data model to accommodate the new requirements. Some companies are starting to use Data Lakes to address this challenge.
Think of a Data Lake as a holding area for all of the raw data from each system used in the E2E labeling process. With a Data Lake, you don’t need to know what reports you’ll want in the future; since there is no denormalization of the data, it can be more easily manipulated to meet your future requirements, whatever they may be. Of course, with a Data Lake model, there is a lot more data to manage, but the tools to analyze and report on higher volumes of data are much more capable of handling these volumes and expect that they will continue to get better.
Ten years ago, most integrations required custom code, but there are industry standard tools like Web Services, XML and APIs to simplify connectivity. Improvements will continue through the use of “connectors” that eliminate the need for any customization between applications. Common data models and taxonomy will be a critical factor in a seamless integration model as well. If attributes are labeled the same way throughout all of the E2E systems, it dramatically simplifies the connectivity design.
Having a set of systems that seamlessly exchange information not only improves data quality and eliminates duplicate data entry, but it also gets companies closer to true E2E visibility.
Single Sign-On (SSO) is also increasing in popularity, meaning companies’ employees will use the same credentials to log in to all of the E2E systems; eventually we’ll get to more widely used “portals” so users don’t have to remember or bookmark all of the various URLs of the systems they work in. A user’s portal will control their task list, and the portal will manage access to all of the underlying systems.
There are many examples of automation in a typical current state E2E labeling process. As a straightforward example, an event occurring in one system can automatically trigger an event or activity in another system. It could be as simple as a change request e-form routing the request to the right people based on the type of change requested, or a quality check like an automated proof-read being done on a file when it’s uploaded. There are lots of examples of automation used today; however, there is much more that could be done.
Many companies are now doing some level of content management but still rely on document-centric data, vs. database-centric data. By defining ‘content elements,’ whether they are images, logos, barcodes or copy, a company can molecularize the traditional digital asset allowing organizations to re-use elements, perform impact analysis of a change quickly and nimbly when rolling out changes. This molecularization will build the foundation on which companies can move from automation to intelligence.
Consider an example of a change to a warning statement in the future: When entering a change request, the appropriate person receives a notification of the CCDSs impacted, and any affected regions are also automatically notified. The change request event automatically kicks off the required processes for the labeling change (IFU, User Guide, label, carton, etc.), includes the right people in the process, and highlights the exact text that must be changed, or even automatically replaces the old warning statement with the new one.
Further, the user is notified that some of the components needing to be changed are already routing due to another change and provide recommendations on bundling/unbundling based on where they are in the approval process, how important the new change is and how much inventory is available.
Of course, until companies build the foundation of process and system standards, along with the integration of the systems that support the E2E process, and molecularization of content, they can’t get to this future “intelligent” state. And this all won’t happen overnight. But ever-improving technology tools can help companies get to real E2E visibility and drive efficiencies and quality through automation and intelligence.
An example of what a company’s future state could look like is listed below. Using a single Data Lake and E2E globally integrated systems, a company could gain much clearer visibility into their entire labeling process.
The benefits to E2E visibility are great – companies experience increased speed-to-market with their products, improved product packaging quality, fewer errors (which means fewer recalls) and consistently adhere to regulatory standards. Users collaborate across departments, removing the miscommunication (or lack of communication) that occurs between operational silos. Inventory management is easier because users can log-in to the appropriate integrated system and analyze data from the Data Lake. And using SSO, a user can access all the systems from a safe-secure portal.
Summary and Next Steps
While the E2E process is similar from one company to the next, each company has a different combination of systems that support and manage labeling and artwork and will have its own strategy and timeline to introduce many of the concepts I’ve described in this post.
If you’re putting a plan together, whether it’s focused on building the foundation, or introducing automation, here are some tips to get you started:
- Be open to change
- Identify areas of risk and opportunity. If you’re part of the E2E labeling process, you likely see examples of this every day
- Use a Digital Maturity Model to help you determine your current state and then further define your future state
- Begin implementing changes to your current state; small wins can go a long way in your overall plan
- Select technology partners who have integration capabilities, experience, and who understand the E2E labeling process and its complexities
To learn more about how Esko can help you with your E2E visibility, contact us.