In the pharma industry, research and manufacturing once existed as separate worlds. The distance between them often slowed new drug development. But over the past few years, driven by guidance from the International Council for Harmonization and global regulators, more life sciences companies are taking a holistic view of these two essential functions and aligning them more closely.
For Merck, this journey began after it acquired Schering Plough in 2009. The company restructured Merck Research Lab (MRL) and Merck Manufacturing Division (MMD). It also adopted a quality by design approach that continues to speed the development of innovative therapies and vaccines. However, its quality management operations had become very complex.
Since 2017, the company modernized and streamlined its IT infrastructure, focusing resources on applications that provide the most value. In 2019, the company adopted cloud-based systems for content management and quality management (QMS) to eliminate manual and paper-based processes. The implementation transcended traditional boundaries between R&D and manufacturing and is redefining processes and tools.
Diane Larson, Director of IT Account Management, leads these efforts. Her 24-year career at Merck, which spans both R&D and manufacturing, has given her a multifaceted view of quality, regulatory, and safety functions and how they connect. Her strategic thinking, ability to bring people together, and manage change have proved critical in successfully driving quality transformation at Merck.
R&D and manufacturing have different goals and ways of operating, but from the start, aligning their quality management programs made perfect sense, according to Larson.
“After all, we both use many of the same suppliers, and we audit similar people,” Larson said. Nevertheless, getting staff to adjust to new tools, approaches, and ways of thinking has been a challenge. “We at Merck have been very siloed, and our different divisions tend to operate autonomously,” she explained.
One Governance Structure Across Two Divisions
MRL and MMD had previously used on-premises QMS and quality documentation systems and couldn’t upgrade them without significant help from vendors. Larson wanted to shift that focus by partnering with vendors to evolve the systems with new functionalities.
The team rolled out cloud quality systems for content management, audits, audit management, inspection management, and issue management across R&D and manufacturing. So far, these efforts have consolidated workflows for seven different functional areas across R&D and manufacturing. Fundamental to progress was ensuring the proper governance structure.
“Originally, there were different governance structures for each of our quality systems. Within a year, the team merged the two structures into one that would cover both applications across R&D and manufacturing,” Larson recalled.
Communication has been crucial to the project’s success, particularly getting the team together to check in with each other. “We needed everyone from MMD and MRL aligned and meeting regularly, and they needed to understand their responsibilities,” Larson explained. Tuesday afternoon status meetings soon became a favorite way to share laughter, air frustrations, or clear up confusion.
The group has also had to work through some philosophical differences between how R&D and manufacturing approached topics. For instance, the manufacturing division preferred a closed approach to data security and locking data down at the plant or site level. The R&D division advocated a more open approach. Ultimately, the implementation team found a way to meet both demands. Subsequently, the manufacturing division decided to mimic the more open approach with their documentation leading to better sharing of documents across both divisions.
Incremental, Rather Than ‘Big Bang’ Implementation
Larson and her team took a phased approach to implementation, dividing the work into chunks and realizing the value for each one incrementally. They started with audits, then moved into inspection, and, finally, issue management. She opted for this approach after conferring with internal stakeholders and groups that had taken a “big bang” approach to software implementation.
The phased approach has not been without its challenges.
“Every time we touched a record, we had to go back and assess whether that change had an impact on the audit or audit findings. We had to be very careful that our work didn’t impact other workflows,” Larson said. However, the gradual implementation allowed the team to realize value from the project early on.
Realizing the Benefits of Change
Despite progress, change management remains a challenge. There is always fatigue with projects like this, but sharing the overall strategy and keeping stakeholders aware of progress is key.
In the beginning, first-time users found that they needed to enter more data into the system than they did with previous solutions. Still, they only needed to enter that information once, and the tools saved them a significant amount of time, reduced errors, and eliminated tedious manual processes.
Over time, Larson has been encouraged to see more users appreciate these benefits and the ability to enter data into the system directly. “We are continuing to work toward use of the system in a more transactional way instead of having to use external Microsoft Word templates and cutting and pasting information.”
The ability to report and analyze data has been another improvement. Now, teams can provide better reports based on accurate data, and everyone can analyze data independently.
Users can also combine data from multiple sources, including old and new audit systems, saving significant effort and reducing operating and querying costs. “If someone is trying to close out a clinical trial and report on all the audits related to that trial, they can access the information in one step. Previously, many manual processes would have been required to obtain it,” Larson explains.
Improved access to documentation has been helpful, especially for those who use both the manufacturing and R&D sides of the cloud systems for different facets of their jobs. The company now has one source for all related documents. If there are five or ten documents they use regularly, users can store them as favorites for quick access, making sharing information much easier.
Best Practices for Driving Transformation
As can be seen from experience at Merck, rethinking the quality ecosystem takes thoughtful planning, a clear strategy, and time to realize benefits.
If you are considering quality transformation for your company, here are five best practices to get started.
- Tackle the fear of losing control of data: The shift to the cloud is an opportunity to rethink roles, permissions, and access to information. You won’t lose control of your data, but it is critical to invest in understanding the appropriate levels of security that will be required for both internal and external users.
- Let go of legacy ways of working: Give your company a clean slate to avoid recreating the same requirements and processes used with legacy systems in a cloud environment. Take advantage of native functionality and built-in best practices in the cloud system to maximize value and increase speed.
- Bring together stakeholders across teams to map processes and requirements: Getting your subject matter experts (SMEs) across groups in the same room is a vital step toward ensuring needs are documented, rationalized, and agreed upon. Take time to evaluate these requirements against what the cloud system offers and what features or configurations are needed for reports, data collection, and analysis.
- Forget paper processes, think digital: Keeping paper on the mind can hold you back. Use the shift to a new system as an opportunity to refine your processes. Getting stakeholders from different areas across R&D and manufacturing can offer the diversity of thought to determine how individual records will look, how workflows will run, or how documents should be used.
- Look for scale: Ensure all quality functionality is offered on a single platform that can scale with business growth and enable continuous improvement over time.
Advancing Quality Management
When asked for advice on how to approach projects like this, Larson emphasized the need to harmonize processes before starting the implementation and prioritizing efforts that will provide the most value. The Merck team is now considering extending the use of its cloud quality system to areas such as risk management.
For companies evaluating is technology can help streamline quality operations, the lessons learned from Merck’s journey are valuable. Align manufacturing and research teams, establish clear governance structures, and take a phased implementation approach. These learnings, paired with our cloud best practices, can help organizations realize the benefits of a quality transformation faster. In doing so, we can accelerate innovation and speed time to market for potentially life-changing medicines and products.