Creating One Version of the Truth for Emergent BioSolutions

Overview

Emergent BioSolutions (EBSI) is a global life sciences company headquartered in Gaithersburg, Maryland, USA with approximately 1,600 employees. They provide specialty products for civilian and military populations that address accidental, deliberate, and naturally occurring public health threats, such as biological and chemical agents, emerging and existing infectious diseases, and opioid overdoses.

Background

Being in a highly regulated environment, it is critical for EBSI to maintain up-to-date training records. EBSI is required to retain training records for a minimum of seven years past a product lifecycle. They are subject to planned and surprise audits by a number of US, Canadian and EMEA agencies. At any point in time, EBSI could have to prove to an auditing agency that they are in compliance by showing evidence that the people they have manufacturing their products are qualified to do so. If they are unable to, they can receive a finding or even be shut down. Not maintaining compliance is an extremely costly risk, both financially and to the company’s reputation. What’s more, EBSI is a high-growth company and their current processes were not scalable to accommodate future transformation. Consolidating data would be foundational to helping them achieve their long-term corporate growth strategies.

EBSI had a variety of approaches and technology platforms across their different sites to maintain training records, but using disparate methods was a cumbersome and costly process. For reasons previously stated, the company decided to use one active source for training that contained all necessary historical data as well as contemporary data moving forward.

Objectives

The key initiative in this project was to implement an enterprise-wise learning management system (LMS) that combined information and harmonized data and content – including training records, curricula and item assignments – from SAP, Veeva, TrackWise, Microsoft Access and Microsoft Excel into SAP SuccessFactors.

Migrating information from different applications that sit on top of multiple technology platforms is always a challenge from a technical point of view. The original systems were designed and implemented for different sets of users, data and processes across the company. Implementing a single LMS would not only bring all the siloed data together, but standardize processes for users and provide a single view of training items and their statuses.

Validation Became the Deciding Factor

While the entire team was prepared to make this change, there was still the challenge of resource availability to execute the project from start to finish. EBSI decided to bring in a vendor to assist with the migration, but there was still a choice to be made on how to handle verifying the migrated and harmonized data, as many companies only offered a non-validated process.

Amy Silins, Senior Director, Project Management Office with EBSI, described the different external support options that were considered for this project.

“We looked at other companies that would have just migrated the data, but then we would have had another step to validate the data once it was in the target system. That would have required extensive use of critical internal resources with minimal bandwidth. We went with Valiance because not only did they migrate the data, but their validated process minimized the back end data validation process.”

– Amy Silins, Sr. Director, EBSI

Overcoming Unexpected Challenges

The approach that Valiance Partners takes with data migrations is to verify not only during one designated stage of the project, but to continuously verify throughout in order to identify and remediate issues faster. Unfortunately, during dry-runs, it was made clear just how intricate some of the details associated with each of the source systems functionality and data storage were.

With what ended up being nine separate sources, there were certain commonalities in how documents were stored and managed across the systems. However, when bringing over the data to a singular new system, the training records from one system that corresponded to records in another also had to be harmonized. Simultaneously, data that was part of another system’s source data had to be excluded.

VERSION INCONSISTENCIES ACROSS PLATFORMS

Not all data are created equal. The rules that are put into Veeva systems are not going to be the same rules that are put into TrackWise or SAP. Because of the change in technologies, the data and documents needed to be maintained in different ways. For example, when documents in Veeva were updated, different versions of the document would remain allowing a user to revisit a prior version if needed. Alternatively, users in TrackWise would update the document directly without versioning it, meaning there would only ever be one available version.

When migrating the documents from both systems, it was a challenge to address version history since Veeva often had multiple versions of a document available, while TrackWise had just the one.

SETTING EXPECTATIONS ON SYSTEM FUNCTIONALITY

Another major challenge was that the EBSI team did not fully understand the operational implication of the target system functionality. This is a common struggle with any platform change as people are used to seeing and dealing with their existing system or systems.

Nagesh Sarma, Managing Director with Valiance Partners and team lead for the EBSI migration project, understood the importance of educating users and setting expectations.

“When a situation like this arises and the target system works in a particular way that’s drastically different than what users are familiar with, it can be confusing to understand if a particular document has come over properly or not, because they are unsure if this is how the data should look and behave once migrated. It’s very important to set expectations with users and show examples of how the data will look and function in the target system. Without this context, the EBSI team could not confidently utilize their new investment.”

– Nagesh Sarma, Managing Director, Valiance Partners

As a response to this, the Valiance team took a more agile approach and increased the number of trial runs performed, adding complexities and rules with each cycle. This way, instead of having to review and learn every aspect of the migration at once, the EBSI team could take the learnings from the previous cycle into the next and develop a more holistic understanding of how to perform these checks and balances with the data as well as be comfortable with their new system.

DISCOVERING AN OLD RULE DURING PRODUCTION

The biggest issue that arose during the migration happened as a result of accidentally including an old rule early in the migration process. After an old rule was changed, it was somehow overridden and the old rule was mistakenly carried over instead. Something so small could have been corrected immediately if caught right away, but unfortunately none of the team members noticed until the migration was in production. One tiny snowflake of a problem had, over time, become a bigger issue that threatened to significantly delay the entire project. Amy Silins was impressed with how Valiance mitigated the matter.

“During cutover, we identified a data problem that could have impacted our go-live date, but it didn’t and that’s because of Valiance’s call-to-order. They immediately came on site to enable effective collaboration with EBSI team members from multiple sites and developed solutions to meet our critical timelines. Valiance really showed up in ways that I don’t think another vendor would have. They acted as a partner every step of the way.

– Amy Silins, EBSI

Results and Business Outcomes

After the project was complete, EBSI was able to decommission all of their other data management systems and eliminate manual spreadsheet work in favor of one unified and scalable LMS. They were able to achieve not only having a single version of the truth for users, but – more importantly – EBSI ensured that they would be able to demonstrate compliance on all of their products at any given time.

“This project was a great success for us. Not only did we achieve the intended business outcomes, but we also identified Valiance as a very strong partner. We are a high-growth company and are continuing to work with Valiance to enable our integration efforts associated with recent acquisitions. They are such a pleasure to work with and they always show up.”

– Amy Silins, EBSI