Data in a pharmaceutical lab provides not only actionable insights in terms of drug development and quality, but also in regard to instrument use, inventory, personnel, workflows and more. Adequate management, storage and accessibility of data is essential to stay in compliance with regulatory requirements, and further allows organizations to identify weak points in their operations, leading to improvements in efficiency, error reduction, cost savings and greater peace of mind.
Labcompare recently discussed the importance of data in the modern pharmaceutical lab with Tracy Hibbs, Principal Product Marketing Manager for Waters Empower Chromatography Data System. Hibbs described the ways that pharmaceutical labs can leverage valuable data insights, and the importance of having a data system in place that meets the needs of today’s busy, regulated lab environment.
“There’s not a smaller amount of data being generated these days. That’s for sure,” said Hibbs. “When we look at the landscape of what’s going on as technology improves and people automate, there’s more and more data collected, it seems like every second … [With] the volume of data being created, they have to do something with it or it explodes.”
Online Data Systems
Digital technology has done wonders for the way we handle data, both in business and in our personal lives. However, many labs still rely heavily on paper-based management systems, and the transition from paper to online is not always smooth. Hibbs acknowledged that “change is hard” when it comes to the digital shift, with organizations and staff needing time to adjust to SOP changes and retraining.
“You can have the drop in efficiency that you can get as you ramp up toward that future state,” Hibbs explained. “That being said, when I am no longer on paper and things are online, I have a lot more transparency. I have a lot fewer errors and I have greater accessibility to the data.”
The switch to an online data management system is worthwhile not only due to the day-to-day benefits of faster data access, data visualization, greater accuracy and more; digital systems ensure laboratories have durable data that fully complies with regulatory mandates. Data is durable when it can be securely stored long-term and accessed as soon as it’s needed – maximizing data durability provides more confidence that data won’t be lost, compromised, or out of your reach in a regulatory situation.
“You can only truly have durable data if you can actually access it when you need it, over the lifetime of the use of that information,” said Hibbs. “That’s really hard to do if it’s on paper.”
Data as a Powerful Problem-solving Tool
Digital systems empower labs to leverage their data in a way that not only saves time and minimizes errors, but also brings new light to trends and correlations that may not have been noticed before. The ability to tap into and visualize these patterns at the click of a mouse offers new possibilities to identify and troubleshoot weaknesses in processes, transforming bits of information into actionable insights. Hibbs provided one example of how an organization could follow the data to diagnose and resolve an overlooked inefficiency.
“You’re able to see that, ‘Oh, wow, why is it taking people 14 days to sign off on something? Everybody signs off Level 2 on the 14th day, we have such a bottleneck.’ Well, they sign off on the 14th day because that was what the process says, but they never really looked at the outcome of that process until they were able to visualize and see it on a chart and in a graph to understand why that’s there,” Hibbs explained.
Analysts can also look to their data when failures occur, to identify potential contributing factors. Hibbs gave the example of an analyst noticing that column failures typically occur after a certain number of injections. Tracking this information enables the analyst to prevent future failures by changing the column after fewer injections, and having this information readily available through an intuitive digital management system guides users to a precise solution much faster.
“You start to think about what that saves you as an organization,” said Hibbs. “It saves a failure and it saves out of specification, and the documentation and investigations around that. It’s not a small thing.”
What to Consider When Purchasing
According to Hibbs, one of the first things labs should consider when planning a change or upgrade to their data management system is how smoothly and effectively the system can be integrated with their existing operations. Difficulties harmonizing the new system with instruments, devices and infrastructure can lead to a rocky and lengthy transition process.
“How well do the pieces connect with each other? How can you effectively integrate the pieces that you need for success? I can sell you the most beautiful thing in the world but if it takes five years or 10 years to implement that, you’re not able to realize the return on investment,” Hibbs noted.
Also important is having synergy between the facets of data management, such as sample tracking, ELNs and application-specific tools like chromatography data software. You want to ensure data can be transferred efficiently and securely with the ability to maintain an electronic trail where these facets interconnect. Complementary systems that are designed to optimize these interconnections, such as Waters’ Empower Chromatography Data System and NuGenesis Lab Management System, can help streamline data management strategies, along with the benefit of a shared service team for both products, said Hibbs.
Onboarding a new data system and understanding how to best take advantage of its capabilities also requires a project management partner with the expertise to address your lab’s needs. Choosing a vendor that will make this expertise available, and work closely with your team to ensure a successful implementation, is an important decision that can ease the transition and save the time and cost of bringing in outside consultants to get the project done.
“You’re gonna have to look for gaps with how you do things today and who you partner with to help you on that journey–it kind of matters,” Hibbs said. “How much experience do they have? What are they bringing to the table to help you get from point A to point B?”
About the Expert: Tracy Hibbs has worked for Waters Corporation since 1999 and has held a variety of positions including Technical Trainer, Business Impact Consultant, Training Manager for Informatics and Data Integrity, and currently, Principal Consulting Marketing Manager focusing on Informatics solutions. Tracy provides support for Waters Empower Software Suite and is concentrated on developing laboratory data management software solutions that help organizations achieve their scientific and operational objectives in regulated environments. Prior to joining Waters, Tracy was a Research Scientist where she gained experience with chromatography and associated data systems.