A Fully Integrated View of LIMS for Manufacturing R&D

Executive Summary

In the case of a manufacturing R&D laboratory serving a range of clients not only as an R&D resource but also as a quality and support/troubleshooting partner, there comes a time when the ever-increasing stockpiles of project documentation in the form of spreadsheets and, even worse, paper, become an unmanageable drain on staff resources, efficiency and therefore an unacceptable cost of time and money. The LabLynx solution vision is a fully integrated LIMS approach that will be detailed below.

Solutions to current issues presented by clients often rely on past solutions. When you rely on the memories of staff to access those solutions, it is clear you are working with a very imperfect system. And even if someone remembers a similar situation in the past, with no effective search mechanism it may be far too long a time before the documents are located – if at all.

It becomes clear – and probably has been for some time – that the introduction of some kind of data management technology must happen at some point. But what technology, exactly, and how do you assess and quantify the needs/requirements and identify the correct solution(s)? Some of the issues:

1. Difficulty finding old files relevant to new work. Scattered around different places, formats. Wasted time/money.
2. Relying on someone’s recollection as to whether there is something they have done before that can help with a current project. End up “re-inventing the wheel” too often.
3. Historical data goes back years, even decades, much of it on paper (not even spreadsheets)
4. Need to evaluate benefits, ROI, to decide if a LIMS or some other data management technology is the answer
5. Benefits should result in good, reliable, complete and easily-accessible data, increased productivity, and cost savings via return on investment (ROI)

Fortunately, the answers lie in a core skill of the lab: research.

The LabLynx Solution Vision

The LabLynx vision for lab data management is a holistic, Integrated Systems Approach. It consists of a single, secure, access-controlled cloud platform that hosts a specific, carefully-selected set of applications designed to interact with each other in a seamless, comprehensive, scalable and flexible schema to manage all of the laboratory’s data for the foreseeable future, no matter how its directions may change – and also support the addition of new tests, departments, personnel and even entire new locations and types of labs. LabLynx can use LabVia to migrate all relevant lab data currently held in spreadsheets or other databases into the ELab LIMS Data Warehouse for easy search and retrieval. Selected paper-based information may also be brought in. The new system will be fully validated and documented, ensuring quality and regulatory compliance. The vision is one of consolidating the past, securing it and making it available to the present and future, along with all ongoing and new project data.

An Integrated Systems Approach

LabLynx takes a holistic approach to providing a turnkey, full data management solution for laboratories. As the graphic above illustrates, it includes all of the LabLynx products that are designed to work together for comprehensive data storage and management, along with any existing apps/systems. This approach, in our opinion, provides the best likelihood of success, for three main reasons:

1. Change is stress, and provides opportunities for risk. The smaller the amount of change while still addressing the issues and pain points, the better.
2. Retaining familiar systems that work promotes better staff comfort level during periods of change.
3. Implementing fundamental systems requires a significant budget. Reducing initial outlay where possible without significantly reducing the increased benefits can help make the budget manageable.

Serving the Stakeholders (the Portal)

The LabLynx myLabCare client-facing web portal offers customized, secure, access-controlled client sample registration and submission, and results report access. The additional benefits it will provide include the ability for the lab to control levels of access, and client ability to enter project/sample information that is immediately stored to the LIMS database, and to print barcoded sample labels to accompany the incoming samples – as well as to see sample statuses and reports without constantly interrupting the lab with phone calls or emails. If desired, an e-payment handling feature may also be added.

The Laboratory Informatics Components (LIMS, ELN, SDMS)

The central core to your updated data management ecosystem is the laboratory informatics set of applications. These include:

• LabLynx ELab LIMS
• ELab Notes ELN
• LabDrive SDMS

These apps are all designed and developed by LabLynx to work together optimally, to meet specific aspects of data management for the Manufacturing R&D laboratory, resulting in a comprehensive solution.

The LabLynx ELab LIMS for Manufacturing

The LabLynx ELab LIMS is our flagship offering, the product of over two decades of development since its initial introduction as the world’s first cloud (web browser-based) LIMS at Pittcon in 1997. No other LIMS has a longer history of cloud technology, or contains a greater inventory of features and functions across the entire spectrum of laboratory industries. Your edition of the ELab LIMS has been customized and pre-configured to specifically meet the demands of manufacturing R&D and QC. Its capabilities comprise a long list, from extensive and granular administrative and access-related controls to flexible user-configurations, to various areas of laboratory process management. Some of these include:

• Sample Group Receiving
• Standard analysis report by single samples
• Item and Specs Management
• Orders Management
• Entity (Client) & Contact Management
• File/Document Management
• Supervisor and Technician Worklists
• Inventory Management
• Test and QC Test Management
• Instrument Maintenance/Calibration Tracking
• Training Tracking
• Object Tracking – Check in/out of storage locations, transfer of custody of samples, inventory, etc.
• QC Charts (Basic)
• Report Management Tools
• Auditing
• Labels and Worksheet: This item includes configuration of the sample label and analytical batch worksheet (one of each).
• Data Warehouse: Configure data warehouse archive table, with all results-related fields and advanced filter for data access/mining
• More…

Additional features/functions and tasks/services are available according to any requirements identified through demos and meetings leading up to the eventual contractual agreement.

ELab Notes Electronic Lab Notebook (ELN)

Custom-built for seamless performance, the LabLynx ELab Notes ELN provides your scientists and engineers with the latest technology at their fingertips, allowing experiments, processes and other reference materials to help guide their work, while all observations, process updates, notes and uploaded images or other files can be recorded and stored in the master LIMS database for instant retrieval any time by authorized users. The ELab Notes ELN is where research meets quality, through leveraging modern technology.

LabDrive SDMS

Scientific data management systems (SDMS) are digital tools for the safety and accessibility of scientific data. These systems allow for more efficient data organization and analysis.[1] LabDrive, from LabLynx goes far beyond basic data storage, organization and access. It is essentially a secure, comprehensive cloud-based office where all non-core LIMS lab-related communications, files and functions can be managed. It is also a platform that allows an almost unlimited range of apps to be added from open source and custom-developed sources. Key features include:

• Secure file exchange within and between organizations
• Collaborative editing of docx, xlsx and more
• File versioning, protection, retire, restore and retention control
• Comment on files, add notes, share links
• Integrated chat and secure audio-video calls
• Calendar, mail and task management tools
• Comprehensive set of security capabilities
• Automate repetitive tasks and build efficient team collaboration workflows.
• Review/approval steps with digital signoffs
• Intuitive, drag-and-drop, user-friendly UX
• Extensive range of additional apps and tools available – dashboard, integration, organization, multimedia, communication, monitoring/metrics and more

The scalability and flexibility of LabDrive helps make the Manufacturing R&D LabLynx Integrated LIMS Solution an agile, future-proof data management strategy for long-term efficiency, effectiveness and ROI.

Integration / Automation / Monitoring (LabVia)

LabVia is our exclusive connectivity solution. It incorporates the very latest technology, including artificial intelligence (AI) and Internet of Things (IOT) techniques along with cloud-based management, to intelligently manage multiple data communications between all kinds of devices, services, systems, or other sources. It consists of two components: the onsite hub and the cloud platform control portion.

LabVia Hub

The onsite part of the LabVia solution is the LabVia Hub. It is a hardware/software product that provides a central nexus point for all of the integrated nodes (instruments/devices, software applications etc.), intelligently managing their data. Full instructions on installation and setup are provided, and a LabLynx professional will guide you through the process. Or, if you prefer, we can come onsite and install it for you, ensuring all interfaced data points communicate properly. Many systems need only be able to provide files that your Manufacturing R&D LabLynx LIMS Integrated Solution can access to process and report, and/or be able to receive sample information from the LIMS. If serial connections are required, then a LabVia channel is utilized, and your hub will link up with the cloud-based software portion of LabVia to ensure perfect data routing and management.

LabVia Cloud

The cloud portion of LabVia is hosted for you in our sciCloud.net® cloud platform infrastructure as a service (IaaS), keeping your integrations securely managed in real time. And any time you need more integrations (e.g., you buy new instruments that you’d like to interface with your system), we can add a new channel for you that is configured to transfer the data you want, in the ways you want them. All maintenance, support and warranty are included in your annual agreement.

The Complete Integration Solution

LabVia is flexible enough to handle all integration management, throughout your complete Manufacturing R&D LabLynx Integrated LIMS Solution. Integrations like:

• SDMS – Scientific Data Management System
• LIMS or other Laboratory Information Systems
• MES – Manufacturing Execution System
• Billing Services
• PLM – Product Lifecycle Management
• Regulatory/Reporting Agencies
• Instruments
• METRC, Other Seed-to-Sale Tracking Integration
• Environmental and Storage Monitoring Devices/Apps
• Field Devices, Mobile, Hand-held etc.
• Reference or Contract Labs
• Point-Of-Care (POC) Devices
• ERP – Enterprise Resource Planning systems
• Other internal or external databases or systems

Bringing in data from the entire range of disparate sources is a key part of any integrated data management solution, and LabVia is the outstanding, powerful tool for the job.

Powering Enterprise Excellence with Analytics/BI (LabVista)

Collecting, organizing and managing disparate data is of vital importance. But the next part is of even greater importance: retrieving, presenting, interpreting and understanding the data so that it results in fully-informed decision making, in both real time/short term and over long-term planning strategies. That’s where LabLynx’s LabVista business intelligence (BI) analytics and visualization platform comes in.

LabVista integrates data analytics, dashboards, and BI reporting functions into your existing software applications and the Manufacturing R&D LabLynx Integrated LIMS Solution, reducing end-user push-back and minimizing the learning curve while enabling a full range of data presentation and analysis. Once you experience its incredible ease of use and depth of functionality you will wonder how you ever managed without it.

The crowning glory of data management, LabVista brings all of the dry, mind-numbing data sets to vivid life, full of meaning and rife with useful, actionable, hard information. Examine all aspects of your metrics to obtain a fuller understanding, and generate all kinds and formats of formal reports – all in a secure, collaborative environment.

A Platform for now and the Future (sciCloud.net®)

Providing the overall secure and reliable cloud platform (platform as a service, or PaaS) for your complete Manufacturing R&D LabLynx Integrated LIMS Solution is sciCloud.net®. This is your dedicated cloud environment that hosts the entire solution, including database and applications. It is a private, secure server network dedicated specifically to your applications and not shared across other clients or laboratories, through Amazon Web Services (AWS), the world standard in cloud hosting. It leverages modern application virtualization technology to enable secure networking across multiple clouds, reducing vulnerability with load balancers and autoscaling groups in each region so that there is no single point of failure. Data are encrypted both at rest and in transit.

SciCloud.net® is fully scalable, guaranteeing reliable, affordable infrastructure hosting for the long-term future. It is designed to be the perfect vehicle for LabLynx’s Next-Generation Informatics (NGi) Integrated LIMS Solution: affordable, state-of-the-art, proven, comprehensive, scalable and reliable, designed for the lifetime of your laboratories.

The Next Step

The next steps forward are designed, more than anything, to facilitate the collection of your lab’s LIMS requirements as accurately and as completely as possible, and with as many details as possible, while also providing your team with clear, transparent and plentiful information about LabLynx the company, the people and our products and services.

Our meetings will be in the form of demos, where you show us your current ways of doing things, including what works as well as the pain points, followed by one or more demos of our systems and resources, focusing on the features and functions relevant to your specific processes and requirements. We will seek to identify the key performance indicator (KPI) metrics that have importance for you, and how we intend to manage them, and your short and long-term goals. We will work with you to tailor your solution to deliver maximum return on investment (ROI). To that end, we will create a Requirements and Budget document, which we will update and adjust as we go through the process. This document will ultimately make up part of your contractual agreement – which itself will be reviewed together and adjusted until it reflects exactly what you want.

Our process is characterized from the start by personal professional communications and collaboration. Our sales team are lab people, and will remain available to you any time, as you are assigned a personal, dedicated LIMS Engineer – who is also an experienced laboratory professional (most are in fact former clients!), Your dedicated LE will work with you throughout the implementation processes, and continue to be your point of contact for as long as you are a LabLynx client. Use the 24/7 LIMShelp help desk for all questions, issues and requests. And feel free to chat directly with your LE or simply call or text them on their cell phone directly. At LabLynx, we greatly value professional, yet personal, people-based, relationships.

LabLynx Consulting Services

If desired, LabLynx can provide any consulting services you may designate, even if you use them to assess other solutions. These include:

• Development of laboratory software requirements
• Support with good laboratory practice guidelines
• Support for compliance and regulatory reviews
• Optimization of workflows
• Planning and staffing of your lab
• Acquisition and integration of instruments
• Validation of software installations
• Improvement of lab performance and efficiency
• Training

Resources

LabLynx has a number of helpful resources designed to aid laboratories in understanding and selecting LIMS, many of which are available through the free laboratory, scientific and medical community LIMSforum.com:

• eBook: Justifying LIMS Acquisition and Deployment within Your Organization
• eBook (includes Manufacturing Lab LIMSpec LIMS Assessment Tool): LIMS Selection Guide for Manufacturing Quality Control

Summary and Contact Information

We at LabLynx very much look forward to an initial meeting and further communications, and we are excited to potentially provide the comprehensive long-term laboratory data management solution that will stand the test of time, as our partnership grows over the coming not years, but decades. We look forward to working collaboratively with you to realize the successful establishment of a shared vision that is mutually rewarding both now, and for a long time to come. Please contact us here (https://www.lablynx.com/get-started/) and we will contact you to set up an initial meeting!