Modern labs generate vast volumes of data, courtesy of expanding throughputs and information-rich analytical technology. With increasing regulatory requirements, the demands on data management systems are higher than ever as organizations work to reduce risk.
These pressures aren’t entirely new—the inefficiencies of paper-based records have been acknowledged and addressed for many decades. The earliest laboratory information management systems (LIMS), used for sample tracking in the lab, are about as old as lab computers. Born of the frustrations of manual sample management, they caught on quickly, and the first commercial solutions were introduced in the 1980’s. Since then, software solutions to paper process woes have arisen for all aspects of lab management, including electronic lab notebooks (ELNs), comprehensive scientific data management systems (SDMS), inventory management, and asset management. These solutions have evolved rapidly alongside developing computational and networking capabilities. Most labs now have one or more of these solutions in place to improve workflow efficiency, productivity, and data accuracy and integrity, with growing adoption driven by a simple fact: paper-based lab systems are not sustainable.
These software solutions form a crowded landscape with differing options and functions, interfaces, and management requirements. Addressing lab challenges like bottlenecks one at a time can result in isolated software from multiple vendors, generating new questions. Do you still need an ELN with a LIMS? Are they compatible? What about asset management, inventory, and workstations? Is your data repository compliance-ready, and do you have both adequate backups and complete archives in place? Integrating these systems into a single, central dashboard saves considerable time and effort in lab management, and is key to forming an effective, comprehensive approach. Upgrading and automating lab processes while maintaining integration may seem daunting, but the right tools not only reform current lab processes, they also lay the foundation for future growth while reducing risk.
THE PROBLEM WITH PAPER
The push for paperless workflows is grounded in cost, efficiency, data integrity, accuracy, and regulatory compliance. Data transcription errors abound with paper recording, and it takes enormous amounts of time and money to adequately maintain records. Data review is onerous with splintered records, searching archives is a nightmare, and audits take weeks of prep.
Moving to electronic data management systems has a dramatic effect on paper volumes. In one example, Vitaquest, a custom contract manufacturer of dietary supplements, overhauled their paper-based processes by implementing a Waters™ NuGenesis™ Lab Management System (LMS) with integrated sample management and scientific data management. They process 3,000 samples per month, and manually transcribed data from output to report, to a hard-copy certificate of analysis form. Not only did automating the process with the LMS improve data accuracy and cut turnaround from weeks to days, it eliminated a ½-inch-thick stack of paper per sample. That’s 1,200 feet of paper per year.
Automating data workflows minimizes data handling and drastically speeds up operations and response time for information requests or audits.
“Everything is more efficient. Our software is validated. Our workflows just work.”
THE IMPORTANCE OF INTEGRATING INSTRUMENTS
Data form the core of every lab—backups for disaster recovery and complete, searchable archives are vital to the ongoing success of a lab. Historically, data outputs from analytical instruments have been printed or recorded in a myriad of formats and locations, sometimes in proprietary file types. Frequently, these instruments are managed at the workstation level using native software packages, but broad integration simplifies their management and smooths the data workflow.
Chromatographic reporting, for example, forms a particular concern for many analytical testing labs. In one case, a major generic pharmaceutical company maintained a diverse set of chromatography instruments, each managed at the workstation level with vendor-provided software. Keeping staff fully trained on each interface and ensuring all workstations were current and validated was challenging and resource consuming. Data were stored across various drives, CDs, DVDs, paper, and spreadsheets, hindering data exchange and creating many points of failure that ultimately increased risk. Their analytical services formed a major bottleneck in product release.
The company needed to harmonize their chromatography data and automated workflows, so integrated a LIMS with a Waters Empower™ Chromatography Data System (CDS). The CDS provided GMP compliant technical controls for all HPLC and UPLC instruments, vastly improving instrument and data workflows and management
To consolidate all analytical equipment and data generation across the lab, a full scientific data management system is required. An SDMS should similarly integrate with sample management and execute appropriate backups and data archival. This type of system is sometimes included in a lab management system (LMS), like the Waters NuGenesis LMS which includes an SDMS, an ELN, and sample management to provide a broad, integrated foundation.
A global pharmaceutical CDMO chose the integrated approach with NuGenesis LMS when upgrading its processes to improve data integrity, allowing them to automatically import data from instruments, scientists, and outside sources. Already running Empower CDS, the network integration and archival improved data accessibility across the company, boosting collaboration and productivity.
Like Vitaquest, the CDMO’s new LMS sample management workflow replaced a time-consuming and error-prone manual, paper-based process. According to their quality and regulatory vice president, the automated workflows increased accuracy and “saved an enormous amount of time every day.” They deployed barcode labelling for samples, chemicals, and instruments, enabling scientists to quickly input and validate data with automated reporting that dynamically linked both instrument and interpreted data. Buy-in amongst staff was high, with one relieved quality specialist noting that the new workflows “completely revised how we’re functioning. The actual launch of the software and changes to how we do things here went so much better than any of us expected.”
Compliance and the need to reduce risk frequently drive changes to data management strategies. The CDMO’s transition to LMS described above was triggered by updates to the FDA’s data integrity guidance (21 CFR parts 210, 211, and 212). Working with Waters, they brought stand-alone legacy equipment into compliance. The automated electronic data workflows enabled generation, indexing, and storage of scientific data in an environment built for compliance with embedded approval mechanisms and compliant e-signatures.
Compliance was a major concern for the generic pharmaceutical company as well, with facilities across Europe, the US, Australia, and South America. Deploying the solutions as individual networks using the same GxP configurations ensured regulatory compliance in a validated environment while streamlining documentation and validation overhead for a considerable increase in operational efficiency.
Both companies described drastically reduced time, effort, risk, and stress associated with audits and root cause investigations.
FULL INTEGRATION AND THE POWER OF PRODUCTIVITY
Full integration of all workflows and software solutions is becoming increasingly necessary. Deploying multiple solutions that do not interface well adds new bottlenecks and counteracts the efficiencies gained by the individual solutions, dragging overall productivity back down.
The pharmaceutical division of a global healthcare organization experienced precisely that—housing 100 chromatographic instruments in a single quality control lab. The lab used two different CDS solutions, a legacy LIMS, and a third-party solution for the weighing process. The lack of integration across chromatography platforms resulted in a continued reliance on a paper information exchange process.
Needing to improve data integrity, the division introduced NuGenesis LMS and made Empower Software the sole CDS. This solution allowed full integration of all workflows, linking internally generated work lists, LIMS, weighing system, reporting system, e-signatures, and inclusion of an audit trail. The lab is now over 90 percent paperless, has a single, compliance-enabled, searchable repository, and completes analytical processes in half the time.
Moving labs into an all-encompassing and integrated management system with a single dashboard, like the one available with Empower LMS, provides the ultimate solution for efficient, streamlined operations. Choosing a software system with flexible integration and modularity provides considerable room for further growth and development, benefitting both the lab and the business. Waters has found that many of their clients begin by addressing a single problem, then discover that their remaining challenges can be solved with the tools at hand.
The CDMO was one such client, first improving compliance. As other departments searched for software solutions to additional challenges, they realized that their newly implemented LMS could fulfill those needs. A full LMS rollout across the departments effectively streamlined their operations. As their VP reflects, “everything is more efficient. Hundreds of bound paper logbooks where people had to make entries every day are now obsolete. Our software is validated. Our workflows just work. Our review time is a fraction of what it used to be.”
Having this foundational management framework in place has since facilitated expansion and new manufacturing initiatives, setting the stage for further growth. Overall, the company has reduced costs, accelerated decision making, and moved clients’ products to market faster.
Ultimately, the modern lab must maximize data integrity, efficiency, and flexibility to meet new challenges as they arise. The right integrated lab management software solution can make that task much easier, delivering better data so you can make faster, quality decisions.