Lab Digitization 101: A Comprehensive Overview

– Introduction
– Section 1: What is Laboratory Digitization?

– Section 2: Key Concepts and Terminology

– Section 4: What’s Involved in Lab Digitization

– Transforming Laboratories by Embracing Digitization

The landscape of scientific research and discovery has witnessed unprecedented advancements in recent years. From mRNA vaccines to cell and gene therapies, the life sciences industry has been at the forefront of driving innovation and improving the quality of human life. However, amid the rush of scientific progress, laboratories have often faced challenges in efficiently managing data, integrating diverse equipment, and optimizing research workflows. Research and development processes heavily rely on accurate data collection, analysis, and interpretation. Laboratories have long been inundated with paper-based records, cumbersome data silos, and data management challenges. The concept of lab digitization has emerged as a solution to these inefficiencies. This article seeks to explain lab digitization and the myriad benefits it offers to the life sciences industry.

What is Laboratory Digitization?

Laboratory digitization refers to the process of integrating traditional laboratory equipment and data silos into a unified digital format, or unified namespace. It involves the use of various data acquisition drivers that enable data contextualization and visualization independent of any specific software package.

Lab digitization is an application of Industry 4.0 principles. Industry 4.0 refers to the integration of advanced technologies into manufacturing and production processes, while lab digitization specifically refers to the use of these advanced technologies to improve laboratory processes and workflows. Lab digitization aims to streamline data collection, analysis, and sharing processes by capturing raw experimental data digitally. Researchers can now utilize electronic data capture systems to record results, measurements, and observations in real-time rather than rely on handwritten notes in lab notebooks. To get away from using paper notebooks, labs often look to Paper on Glass (PoG) digitization solutions. These digital records, supported by standardized data formats, facilitate seamless data sharing and collaboration among research teams. Data can be shared not only within a single lab but also across different geographical locations. This shift towards a digital environment enables researchers to access and analyze data efficiently, leading to improved decision-making processes and accelerated research outcomes.

Current State of Laboratory Environments

Traditionally, laboratories rely on a paper-based system to record experimental data and protocols. Researchers meticulously note observations, results, and procedures in lab notebooks, creating an immense repository of information stored solely on paper. While these notebooks serve as tangible records, they also present significant limitations. The process of manually recording data is time-consuming, susceptible to human errors, and can potentially compromise the integrity of research outcomes. Moreover, accessing historical data or sharing it with collaborators and peers requires substantial effort and coordination. In addition to data management obstacles, laboratories often face challenges using specialized laboratory equipment from different manufacturers. Each piece of equipment often comes with its own proprietary software and data access methods, making it difficult to establish a universal method of communication and data extraction across different instruments.

These limitations in traditional laboratory practices sparked the need for a solution that can enable laboratories to move beyond manual record-keeping and start using automated data collection to promote data accessibility. Lab digitization emerged as the answer and aims to revolutionize how laboratories operate, manage data, and conduct research.

Importance and Significance

The life sciences industry thrives on data-driven insights and evidence-based decision-making. Therefore, accessing accurate and real-time lab equipment data is critical. Lab digitization enables data capture and integration and simplifies access and sharing of historical data to accelerate research progress. Furthermore, digitizing and historizing data prevents data loss. If a paper lab notebook is lost or purposefully taken, the data stored within is gone. With lab digitization, researchers can better harness the power of data to drive innovation and develop life-changing medicines, rather than spend time combing through paper records or manually extracting data from equipment.

Key Concepts and Terminology

Industry 4.0

Industry 4.0 is a common industry term used to describe the fourth industrial revolution that is currently happening in manufacturing. The third industrial revolution adopted computers and automation into manufacturing processes. The fourth industrial revolution builds on the third by enhancing existing computerized systems with data and analytics. Industry 4.0 is characterized by leveraging cloud computing, machine learning (AI), and connected devices through the Internet of Things (IoT).

Unified Namespace

A Unified Namespace (UNS) acts as a centralized repository of data, information, and context. Any application or device within an organization can publish or consume data needed for its use. Each application or device and the data it generates is uniquely identified to allow for easy identification. By normalizing disparate data structures across the enterprise within a single hierarchical framework, the UNS creates seamless business data connectivity.

Rather than having isolated namespaces across the business which creates data silos, each software system gathers its data from a singular Unified Namespace. Once a new data point is added to the UNS, it is immediately accessible to all nodes in the business. A node is defined as any application, or software in the network which produces or consumes data. A UNS eliminates the challenge and cost of creating and maintaining an unfeasible number of discrete connections for each data point between multiple namespaces.

Paper on Glass

Paper on Glass (PoG) describes the process of digitizing a traditional paper-based workflow or batch record. This method of digitization minimizes retraining, as it mirrors the paper records scientists and other lab personnel are already using, just on a screen instead of paper. Mobile tablets are often used as the digital interface for execution as they are just as portable as paper notebooks. PoG approaches typically have significant benefits when compared to paper notebooks. The data generated while executing a workflow/batch record is already in a digital format which simplifies data capture. Losing or breaking a tablet is inconsequential to data loss as data is captured the moment it is generated. Finally, quality review is often faster as it is no longer necessary to comb through entire paper batch records.

Benefits

Enhanced Data Integrity

Data integrity is a cornerstone of reliable and trustworthy research data. With manual data entry, there is a human error risk due to transcription mistakes or misinterpretations of data. Data entry errors are eliminated when the need for manual data entry is eliminated by capturing data directly from laboratory instruments, equipment, and sensors. Furthermore, digitized systems can often incorporate validation checks, ensuring that collected data conforms to predefined standards such as ALCOA+. Another way lab digitization supports data integrity is through real-time data monitoring and automated data capture, minimizing the possibility of data loss or eliminating the possibility of data manipulation. Each step of the experimental process is recorded and timestamped, creating an audit trail that enhances transparency and accountability. This strengthens the credibility of research findings and ensures compliance with regulatory requirements and industry standards.

Increased Accessibility

With the digital tools available today, the ability to remotely access data on the fly is now a possibility. Lab digitization empowers researchers to securely retrieve data within the organization from anywhere, at any time, using computers, tablets, or mobile devices. This unprecedented access to data enables scientists to quickly check experiment status and make better-informed decisions. Increased accessibility can lead to security vulnerabilities, however with proper permissions in place data is protected and is only accessible to those with approved access.

For multi-site research projects or collaborations with external partners, lab digitization provides a unified platform that all stakeholders can securely access. Collaborators from different geographical locations can share results, methodologies, and analyses. Scientists can quickly access and view experiment data, business executives can view data dashboards, and data scientists can analyze big data pools with advanced analytics to discover trends at the same time.

Streamlined Implementation

Digitizing all lab equipment may seem daunting, but Skellig’s solution is designed with user-friendliness and ease of implementation as a priority. Our lab digitization platform offers intuitive interfaces that facilitate the seamless integration of existing laboratory equipment and instruments. The transition from traditional methods to digitized workflows usually does not require retraining. Additionally, Skellig’s platform can be tailored to meet the unique needs of each laboratory. We make sure we understand each lab’s specific requirements prior to integrating any piece of equipment. We work with laboratories to make sure they can quickly adapt to the new digital environment and maximize the benefits of lab digitization without disrupting ongoing research activities.

What’s Involved in Lab Digitization

Systems, Equipment, and Brands

Common systems that can interface with Skellig’s Lab Digitization Solution include Laboratory Information Systems (LIMS), Electronic Lab Notebooks (ELN), Manufacturing Execution Systems (MES), Laboratory Execution Systems (LES), Laboratory Orchestration Platforms, and Laboratory Quality Management Systems (LQMS). Common Equipment includes analytical balances (scales), cell analyzers, centrifuges, refrigerators, freezers, cryogenic (LN2) systems, incubators, next-generation sequencing (NGS) systems, and shakers/rockers.

Common manufacturers of these equipment types include Agilent, Beckman-Coulter, Bio-Rad, Cole-Parmer, Eppendorf, Leica, Mettler Toledo, Molecular Devices, Roche, Sartorius, and Thermo Fisher Scientific.

Tech Protocols Used in Lab Digitization

Skellig’s Lab Digitization Solution can interface with equipment through a variety of communication protocols including OPC, MQTT, Serial to ethernet, Omron, Allen Bradley PLC, Siemens PLC, Opto22 groov EPIC and Modbus. As each piece of equipment often only supports one or two communication methods, it is critical for any lab digitization solution to support a wide variety of protocols.

Lab Equipment Already Digitized by Skellig

Some of the lab equipment already digitized by Skellig includes the Orion Versa Star Pro, Orion Star A215 pH, Cambridge Pressure Logger, Ohaus Benchtop Balance, Repligen FlowVPX, Emtec Ultrasonic Flow Meter, PendoTECH Cross Flow Filtration TFF, PressureMAT Sensor Monitor, SciLog SciPress pressure sensors, Osmo Pro, Akta/Unicorn automation platform, Mettler Toledo Benchtop scales, Millipore Mobius Single-Use Mixer (SUM), and Thermo Fisher A215 pH meters.

Regulatory Guidance

The administration of blank paper forms requires labor-intensive processes and oftentimes does not meet tightening regulatory expectations. The FDA is encouraging laboratories to digitize through guidance documents and warning letters. Stason Pharmaceuticals and Tender Corporation were both cited for data integrity issues and required to make “Technological improvements to increase the integration of data generated through electronic systems from standalone equipment (e.g., balances, pH meters, water content testing) into the LIMS network.“ Data creation must change from recording observations on paper to digital capture to ensure regulatory compliance and data integrity.

Transforming Laboratories by Embracing the Digitization

Lab digitization has emerged as a solution to the problems that come with paper-based execution within the laboratory environment. By integrating traditional laboratory and equipment data into a digital platform that is easily accessible to all systems and stakeholders within an organization, researchers can enhance data integrity, increase accessibility, and streamline their research processes. Embracing lab digitization is a necessity for laboratories aiming to stay competitive and contribute to groundbreaking discoveries.

We encourage researchers and laboratory professionals to explore the potential impact lab digitization can have on their own organization and processes. For more information and assistance with lab digitization solutions, feel free to reach out to Skellig, a leading provider of innovative automation solutions tailored to meet the unique needs of the life sciences industry.

FAQs

1. How is this different from LIMS?
a. LIMS is software designed for a specific purpose. The specific components of LIMS systems are highly dependent on individual implementations and each laboratory’s requirements. However, all LIMS systems have a workflow component and some data management capabilities. Skellig’s lab digitization platform collects data generated from lab equipment and makes it available to other systems and business units within an organization. It does not attempt to take over workflow management or other LIMS functionality.

2. Why not get data from LIMS?
a. By housing data within the lab digitization platform first, the organization gains full access to unprocessed data. This data can then be ingested and handled by LIMS accordingly. It also enables the data to be easily shared across other systems throughout the organization.

3. Is lab digitization only suitable for large research institutions?
a. No, lab digitization is beneficial for laboratories of all sizes. Whether it is a small research team or a large institution, digitizing laboratory data and equipment streamlines processes and enhances collaboration, improving overall research efficiency.

4. Can lab digitization help with compliance and industry regulations?
a. Yes, lab digitization can significantly aid in compliance efforts. By maintaining accurate and audit-ready digital records, laboratories can demonstrate adherence to industry regulations and easily respond to inquiries from regulatory authorities.

5. What types of lab equipment can be digitized?
a. Any lab equipment with a data egress option such as ethernet, USB, or serial ports can be integrated into a lab digitization platform. Example equipment includes spectrophotometers, chromatography systems, microscopes, and more.