In a recent letterdated June 17, 2024, the FDA raised significant concerns about the data integrity and management practices at a contract research organization (CRO), highlighting issues with their ISR processes during bioanalytical studies. This letter detailed several critical areas where data anomalies and mishandling led to questions about the reliability of bioanalytical study results. Here, we explore the FDA's ISR findings and discuss how LabWare's Bioanalytical LIMS and ELN platform could have mitigated these issues. 

Data integrity is fundamental across numerous industries, but the terminology, practices, and language can often be complex and inconsistent. This article aims to clarify the concept of data integrity within laboratories and illustrate how LabWare LIMS canplay a vital role in ensuring accurate, reliable data, specifically addressing and mitigating regulatory concerns around dry-labbing.  

Effective data management is the backbone of bioanalytical laboratories, ensuring accuracy, compliance, and productivity. While traditional bioanalytical LIMS (laboratory information management systems) serve essential functions, they fall short in several critical areas, such as inventory management, instrument maintenance, and sample preparation documentation. Enter the LabWare enterprise laboratory platform for bioanalysis, which seamlessly combines the strengths of LabWare LIMS and LabWare ELN (electronic laboratory notebook) into a single, all-in-one package. This comprehensive system addresses the critical gaps found in traditional bioanalytical LIMS and enhances overall lab efficiency and compliance.

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WILMINGTON, Del., June 4, 2024 /PRNewswire/ -- LabWare, a global leader in Laboratory Information Management Systems (LIMS) within the Pharma and BioPharma industry, last month played a key role in spearheading and guiding an exploratory delegation led by the Governor of Delaware to investigate and exchange opportunities within Ireland's BioPharma sector. This visit focused on Ireland's success in biopharmaceutical manufacturing, fostering collaborations, exploring innovation, and leveraging valuable insights from LabWare. Other participants included the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) and the University of Delaware. 

Patrick Callahan, LabWare's Director of Analytics and Tom Brohan, LabWare's Ireland Service Delivery Manager, the sole industry participants, engaged with esteemed organizations, including Ireland's National Institute for Bioprocessing Research and Training (NiBRT,  the University of Limerick, Trinity College, regional economic development entities like IDA Ireland and The Science Foundation Ireland Research Centre for Pharmaceuticals (SSPC) and several of LabWare's BioPharma clients including Astra Zeneca. 

During the delegation visit, key observations were made: 

• Advancements in Ireland's Biopharmaceutical Manufacturing: Substantial investments in workforce development, government incentives, and robust collaboration between government, industry, and academia have all contributed to their progress.
• Growth in BioPharma Manufacturing and Research and Development: Ireland's trajectory in Manufacturing and R&D, backed by venture capital and state-of-the-art facilities, presents significant opportunities.
• Technology Companies' Interest: Major tech players like Amazon, Microsoft, and Google are intensifying their focus on Ireland's BioPharma sector, indicating a conducive environment for innovation.
• Commitment to Science Education: Ireland's early investment in science education nurtures a skilled workforce and fosters collaborative research initiatives.

Patrick Callahan, representing LabWare, remarked, "Our engagement and leadership with Ireland's BioPharma sector has been key to our growth in the BioPharma industry. The commitment to innovation and collaboration we have witnessed aligns perfectly with LabWare's ethos of driving technological advancements in the biopharmaceutical industry and our investment in scientific education." 

LabWare identified numerous collaboration and expansion opportunities during the visit, reinforcing its commitment to advancing technology integration and strategic partnerships within the global biopharmaceutical landscape. 

This experience underscores LabWare's dedication to innovation and collaboration in driving the biopharmaceutical industry forward.  

"As an Ireland native and long-term employee of LabWare, I am proud to see the significance of software advancements in the Biopharmaceutical space and showcase what has transpired in our country.  We look at this as illuminating the path for future innovations in the U.S." says Tom Brohan, LabWare's Ireland representative.  

"Organizations without a solid data management strategy are on a collision course with catastrophe." 

Thorton May, CIO Columnist 

The consequences of poor data management are evident in many large firms, which often struggle with what is known as a "Major Data Mess." This term effectively captures the chaos from decades of accumulating data without a coherent strategy. These circumstances highlight the need for robust data quality practices and how an effective laboratory information management system (LIMS) master data management plan can shield your organization from similar problems. By adopting strong master data management, your lab can enhance operational efficiency, reduce costs, and avoid the issues of disorganized data. 

A well-structured Master Data model, tailored to your business needs, can significantly accelerate the LIMS implementation process and set the system up for optimal success. 

Imagine a scenario where a simple software oversight could jeopardize your entire operation. A manufacturer of finished pharmaceuticals faced this unfortunate situation during a U.S. FDA inspection in April 2024. The investigatorobserved that the drug company lacked appropriate controls over its systems, allowing unauthorized changes to master production and control records. A commercial software used for microbiology documentation, integrating with barcode scanners to automatically populate sample locations, sample information, and time and date details, allowed analysts to override the scanner and make manual entries. Surprisingly, the software lacked an autosave function, leading to untracked changes and significant data integrity issues. 

Integrating the Internet of Things (IoT) into laboratory environments represents a crucial shift in the constantly evolving world of scientific discovery, paving the way for a more interconnected and efficient future that's more interconnected and efficient. A recent LabWare workshop illuminated the transformative impact of IoT—or, as aptly coined, the Internet of Laboratory Things (IoLT)—on the laboratory world, revealing a landscape where devices communicate seamlessly, enhancing operational efficiency and paving the way for groundbreaking advancements.

Bioanalytical testing is a cornerstone in pharmaceutical development, providing crucial data on pharmacokinetics, pharmacodynamics, and immunogenicity to determine the patient safety margins of effective new drugs. For laboratories conducting small and large molecule bioanalysis, harmonized sample management processes, study protocol organization, quantitative assay development and validation, and data flow optimization are compulsory. Adopting a combined LIMS and ELN platform transforms disconnected practices, providing better control over data and improving efficiency and compliance with regulations. 

The digital revolution is transforming industries worldwide, and the petroleum sector is no exception. A landmark event in this transformation was the recent announcement that the Egyptian General Petroleum Corporation (EGPC) and Cairo Oil Refining Company have partnered strategically with laboratory software leader LabWare. This collaboration aims to implement LabWare’s Laboratory Information Management System (LIMS) to improve EGPC and Cairo Oil Refining laboratories' operational efficiencies and data management practices.

Green Valley Analyticsis a full-service independent analytical testing laboratory fully licensed by the Massachusetts Cannabis Control Commission. The lab offers a comprehensive menu of services to support cultivators and manufacturers licensed to grow and produce medical and recreational cannabis products.In a recent conversation with the laboratory's CEO and co-founder, Jonathan Ferguson, the spotlight was on LabWare GROW, a cloud-based laboratory information management system (LIMS)purpose-built for CBD/THC testingand its instrumental role in revolutionizing cannabis laboratory workflows.

Cannabis testing laboratories are essential in protecting the safety and quality of cannabis products. Cannabis testing helps identify and quantify the levels of cannabinoids (such as THC and CBD) and the presence of harmful contaminants like pesticides, heavy metals, mold, and bacteria, safeguarding consumers from health risks. The cannabis plant's chemical diversity, variability in cannabinoid concentrations, difficult contaminant detection, evolving industry practices, and the continuous emergence of new compounds make testing a complex endeavor. 

Lüneburg, DE / Delaware, US

LabWare® has achieved the “Ready” level required to join Körber's Ecosystem of partner companies.

With that, the two companies are taking the seamless integration capabilities between LabWare’s LIMS (Laboratory Information Management System) and Körber’s PAS-X MES (Manufacturing Execution System) to a new level of cooperation.

Körber's collaboration with LabWare marks the next milestone following the launch of Körber's "PAS-X LIMS Integration" program, a new element within the Körber Ecosystem. This program offers customers improved convenience in identifying LIMS suppliers compatible with PAS-X MES. It demonstrates to customers that Körber and its partners can significantly reduce the effort and risk involved in integrating LIMS with Körber's world-leading Manufacturing Execution System PAS-X MES by using a standardized interface. 

LabWare, a trusted partner to most of the top 25 global pharmaceutical companies and a worldwide leader in laboratory informatics, brings profound expertise and operational excellence to this relationship. “Our LIMS is used at more than 29,000 laboratories with more than 150,000 daily users and a billion samples tested a year,” says Mark Gonzalez, Technical Director at LabWare. As a certified partner, LabWare demonstrates seamless integration capabilities with PAS-X MES. “The successful collaboration between LabWare and Körber has already greatly benefited our shared customers over the years,” Gonzalez adds. 

The integration of MES and LIMS has emerged as a pivotal component in the digital transformation journey within the pharma and biopharma industry, especially given the laboratory's critical role in the overall production and supply chain processes. Lars Hornung, Senior Principal Alliances & Technology Partners Software, Körber Business Area Pharma, elaborates: “For instance, as part of the manufacturing process, PAS-X MES triggers a sample request to the LIMS, and the LIMS communicates detailed sample data back to the MES, enabling efficient label printing for each sample. After sample collection, PAS-X MES sends a sample confirmation to LIMS, including additional information for Quality Control (QC) purposes. The laboratory conducts the tests, and LIMS manages the results, which are then transmitted back to MES for further processing. Therefore, seamless integration between these systems is vital to streamlining processes and eliminating human error.”