The data management challenge
A successful lab is a lot more than just a scientific hub. Today, it is a digital data enterprise. A biobanking lab with a vast and complex inventory of samples, an oil and gas lab managing hundreds of concurrent tests, or a food and beverage lab tracking incubation in real time, it’s all data.
Day by day, week by week, it grows at a fast rate, creating an urgent need for an integrated informatics platform where that data is able to be securely and efficiently stored, retrieved, and analyzed.
From the experts
If the situation presents itself, take the opportunity to reduce the footprint of legacy ELN and LIMS systems, consolidate them into one system that is more suitable for expansion with the enterprise, and extend it to collaborators and supply chain partners.”1
Michael Shanler, Analyst, Gartner
Should that platform be one-size-fits-all across industries?
A diagnostics lab requires advanced tracking of biospecimens, while a pharma lab requires regulatory documentation. Usually, each would start with the same basic building blocks: a Laboratory Information Management System (LIMS) with standalone point solutions like an Electronic Laboratory Notebook (ELN) or a Laboratory Execution System (LES) put together to approximate an end-to-end solution.
Through a complex development and validation process, every one of these labs would customize their platform in response to their divergent requirements. Repeated across every industry, for every organization, this bulky deployment process presents a huge amount of effort and cost, and a huge amount of risk. Until now.
The case for a pre-configured, fully integrated solution
A purpose-built LIMS, with the option to embed ELN, LES, and other modules, leapfrogs the lengthy customization process. Because your industry’s best-established workflows and operating procedures determine its functionality, your platform is configured to meet your needs before you’ve even begun. The advantages of this accelerated start are numerous and notable.
1. Save Money – Improved functional efficiencies and quicker deployment translate to significant cost savings. Abandoning stand-alone ELN and LES products and other point solutions in favor of fully embedded, pre-packaged modular capabilities in one streamlined platform will help you optimize your return over time.
2. Save Time – A pre-configured LIMS can deploy up to 75 % more quickly than a more typical LIMS system. Its purposeful functionality reinforces a consistent, industry-standard workflow to help your lab attain better productivity and efficiency.
3. Stay Focused – In a purpose-built LIMS, lab managers can conceal or disable non-essential functionality. The result is a user experience which is responsive not just to your industry, but also to the specific requirements and use cases of your front-line staff. That means more productivity, shorter training time, and better overall quality.
4. Decreased Risk – A purpose-built LIMS mirrors industry best practices and the latest regulatory and compliance developments within your industry. As a result, it stops the requirement for custom code and decreases the overall configuration effort, lowering the risk inherent with other LIMS projects.
5. Future-Proof a Business – Industry regulations and conditions change over time, and your lab is likely to also change. New tests, new service areas, or new users may be added as you expand.
A purpose-built, modular LIMS which makes use of industry-standard web technology can grow with you, from startup labs through to worldwide operations, without the prohibitive cost, time, and compliance issues of specialized coding.
Built better for the biobanking industry
Registries, biobanks, and biorepositories must allow advanced biomedical research while protecting data integrity and confidentiality. To achieve this, they require a data management solution compliant with patient privacy, regulatory requirements, and ethics policies, which is designed for richly annotated biospecimens.
For the majority of these facilities, success is determined by the answers to two crucial questions:
1. Is the facility able to connect the right people to the right biospecimens securely and quickly?
2. Is the facility compliant with the latest regulations and best practices?
The first question is about how biobanks support research interests while considering issues of patient privacy, as stipulated in the Health Insurance Portability and Accountability Act (HIPAA).
A single specimen may move between external and internal researchers; it may be divided into aliquots or pooled into a composite sample; it may be engaged in academic or clinical protocol. The potential for error multiplies at each twist and turn in this chain of custody.
Biobanks utilizing manual-intensive systems are particularly vulnerable; the integrity of epidemiological and medical data frequently depends on a user’s ability to accurately copy and paste a column of data from one spreadsheet to another.
One wrong click and clinical data may be scrambled or patients’ consents may be lost, which would be a catastrophe. In order to safeguard against such errors while facilitating streamlined research and collaboration, biobanks must have an alternative to manually built datasets and data silos. They need an automated and centralized solution which can:
- Manage internal and external requests and uphold donor privacy.
- Track and confirm specimen details, including precise location and genealogy.
In response to question two, like labs in most industries, biobanks need to adhere to the data integrity regulations enforced by the U.S. FDA’s 21 CFR Part 11 or the EU’s Annex 11.
Biobanks are also under pressure to uphold a wide scope of industry-standard best practices proposed by organizations such as ISBER, the International Society for Biological and Environmental Biorepositories.
In 2012, the College of American Pathologists (CAP) introduced the Biorepository Accreditation Program (BAP) to help biobanks understand, apply, and maintain these best practices. CAP BAP is an elective program that, as of early 2018, has engaged 66 biorepositories; it is just one example of the many influences which affect biobanks as they navigate an ever more complex regulatory landscape.
With the right information management system such complexity would be a lot simpler. A system that is agile enough to adapt alongside changing regulations, robust enough to maintain a high security threshold, and intuitive enough to support global collaboration efforts between researchers.
That system is LabVantage Biobanking, it supplies advanced functionality based on more than 15 years of experience working with biobanks. The result is a platform which has the benefits outlined below.
Find samples and investigate genealogy using advanced inventory management tools
Track specimens and know with precision who is involved at every point along the chain of custody. In addition, easily uncover the genealogy of derivatives, aliquots, and pooled samples.
Quickly locate specimens by utilizing expanded search criteria
Users are able to run searches based on sample or subject. This means researchers are able to search the specimen collections and related clinical data more easily.
Protect donor privacy with phi masking
The platform provides enhanced privacy control with the user-driven Protected Health Information (PHI) masking function. It enables managers to anonymize information related to a specimen selectively, ensuring data integrity in compliance with HIPAA.
Save money by optimizing storage space
The platform includes a visualization tool which supplies a hierarchical view of specimen flow. This actually shows the freezers and the boxes and plates within them. This enables users to track inventory closely and to uncover opportunities to better manage freezer capacity, lowering energy costs and enhancing efficiencies overall.
The accelerated implementation experience
Selecting a purpose-built LIMS is like strapping a rocket booster to the implementation process. It means much of the background work is done before you even start, giving you a boost without sacrificing compliance, consistency, or performance.
Source: LabVantage Solutions
| A Typical LIMS Implementation |
LabVantage LIMS Implementation |
| Minimum 12 months to deploy |
Deploys in as few as three months |
A huge up-front investment drives this deployment process, which begins with a detailed discovery and documentation of user needs and progresses through multiple design iterations and testing phases. Heavily customized and configured systems introduce risk and its corresponding compliance requirements, necessitating a significant investment in validation and test planning.
Once fully customized and compliant, the system is ready for use – however only after a significant investment in training for all users and administrators. Training timelines are contingent on the complexity of customization and are often a significant factor in typical deployment costs. When updates are required after deployment, the vendor must be involved for specialized customization and/or installation, further adding to the costs and time required to maintain performance. |
As this system is already configured for your industry using established industry best practices, the implementation process is much more efficient. Data templates are integrated and the functions and products most commonly relied upon by industry-specific users are engaged and ready. If further configuration is required, the system’s modular design is easily adaptable without code; ongoing updates and enhancements require no specialized skill or outside management. |
Improve data integrity with controlled vocabulary
The platform compels all users to apply standardized terminology through pre-established specimen accessioning. There are minimal “free text” forms; instead, users choose category labels from drop-down menus, which helps to establish a single consistent language and reduce confusion.
The best and most secure technology in the industry
LabVantage’s feature-rich LIMS is fully web-hosted, giving networked users access to the same information from one easy-to-use, secure system – whether they are across the world or in the same lab.
Hosted on-premise or in the cloud, the system also connects labs with third-party contributors outside of their firewall, such as manufacturing partners or research organizations, enabling harmonized data input through a single platform.
Run your digital enterprise with LabVantage
Over every industry, every successful laboratory functions at the nexus of technology and talent: the right people utilizing the most streamlined, best tools. As the market leader in modern and efficient LIMS solutions, LabVantage is crucial to that winning formula.
A system which adapts to your requirements – without code
LabVantage’s purpose-built LIMS has a modular design which invites further configuration and adaptation without specialized coding skills. Users are able to configure their platform themselves or rely on LabVantage’s global professional services team to do it; both choices decrease the effort, cost, and complexity of additional testing and compliance.
A fully interoperable experience from beginning to end
The end of siloed informatics systems for individual use cases within a product life cycle. LabVantage’s system interconnects your processes within a single, central hub.
This means that documentation produced during early R&D explorations is consistent throughout manufacturing and final quality assurance testing. The result is a more efficient lab with fewer opportunities for risk, resulting in a stronger business performance overall.
A professional support team in lockstep with your needs
LabVantage’s global professional services team of solution engineers, business analysts, and project managers offer consistent and top-rated support services from deployment through validation and ongoing monitoring.
LabVantage looks to become more partner than vendor via their managed services offering; for example, their team will monitor, optimize, administrate, and enhance your system regularly, giving you greater confidence and more control over your labor and IT costs.
Conclusion
LabVantage Biobanking helps registries, biobanks, and biorepositories to store and distribute high-quality specimens while ensuring donor privacy and regulatory compliance. Enhance your biobank with the full-featured, entirely web-based informatics platform designed specifically for success in your industry.
References
1 Gartner, “Hype Cycle for Life Sciences, 2018”, Published 25 July 2018, Analyst(s): Stephen Davies, Michael Shanler, Jeff Smith
About LabVantage Solutions
LabVantage Solutions, Inc. is the leading global laboratory informatics provider. Our industry-leading LIMS and ELN solution and world-class services are the result of 35+ years of experience in laboratory informatics. LabVantage offers a comprehensive portfolio of products and services that enable companies to innovate faster in the R&D cycle, improve manufactured product quality, achieve accurate recordkeeping and comply with regulatory requirements.
LabVantage is a highly configurable, web-based LIMS/ELN that powers hundreds of laboratories globally, large and small. Built on a platform that is widely recognized as the best in the industry, LabVantage can support hundreds of concurrent users as well as interface with instruments and other enterprise systems. It is the best choice for industries ranging from pharmaceuticals and consumer goods to molecular diagnostics and bio banking. LabVantage domain experts advise customers on best practices and maximize their ROIs by optimizing LIMS implementation with a rapid and successful deployment.
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