The Importance of Digital Transformation in Laboratory Informatics

For companies in the life sciences industry and pharma manufacturing sector, a long-standing challenge is the need to digitize and make available legacy data for drug development workflows. At the same time, they must also incorporate the latest technologies into drug development and testing processes, such as next-generation sequencing or other high-content workflows.

Laboratory informatics software play a vital role in maintaining accuracy and data integrity in quality assurance and quality control laboratories. A high degree of automation also plays a decisive role in the future of laboratory software. The future is evolving towards more fully integrated solutions from concept to consumer, where the systems, lab techs and clients are more tightly integrated, with the end goal of entering data once and enabling it to flow through all business processes.

What is digital transformation?

Digital transformation cannot be defined concisely, but many organizations use the term to describe the adoption of data management infrastructure to allow laboratories to work more efficiently and with greater transparency. Importantly, it goes beyond simply shifting toward a paperless lab. Digital transformation gives companies the ability to derive more intelligence from their data, which can help to improve products and product safety.

Working with paper-based systems in principle is still possible, but for the quality assurance and quality control lab, it is no longer cost- or time-effective. The level of data generated and interacted with on a daily basis makes the responsibility of laboratories to safeguard data integrity even more necessary. With the help of smart digital solutions, data is not only safer, but also more contextual and accessible over the long term.

Full digitization and automation is the future of a flexible, modular working environment. With the right interfaces to other company systems such as manufacturing execution systems (MES) or enterprise resource planning systems (ERP), in-process controls and batch releases can be simplified. The use of QR codes or RFID chips enables automated tracking of samples and laboratory materials such as reagents, chemicals or equipment.

Solutions that support the entire product lifecycle management process whilst remaining flexible to support changing workflow and data management needs can aid in digital transformation and the move to the lab of the future. Such solutions improve the reliability of laboratory sampling processes, support compliance with global regulatory requirements and industry standards and provide comprehensive reporting, monitoring and analysis capabilities.

The issue of “technical debt” in laboratories

Many modern laboratory information management systems (LIMS) have been created with digital transformation in mind. While manual systems can struggle to document and follow procedures, a LIMS is ideally suited for this functionality. Satisfying requests for data becomes much easier with the data integrity and transparency of built-in audit trails, which track every activity in the lab.

As outdated systems and laboratory instruments are updated and replaced, the issues of “technical debt” need to be addressed. Many of these platforms and software will still need to be maintained in order to access the data held in proprietary formats. This comes at a significant cost to laboratories which is an unfortunate reality that exists in the industry.

Tests carried out using this equipment will need to be validated on the data generated, or additional tests will need to be performed to justify that the system was suitable. Investigations will need to take place in order to determine corrective and preventative actions. Informatics platforms can prevent this time and cost-associated rework due to the use of unqualified equipment.

An evolutionary rather than revolutionary path to digital transformation

In order for laboratories to protect their investment and derive maximum insight from data, they must be able to negotiate the rapidly evolving technological and digital landscape seamlessly. As opposed to the revolutionary approach which requires building entirely new platforms, an evolutionary stance on product development protects customer investments while safeguarding their data

A LIMS solution prevents the need for time-consuming and costly actions that will ultimately slow down workflow. This way, it can be ensured that samples are only sent or assigned to instruments that have been correctly calibrated and maintained and by managing any needed maintenance scheduling. Facilitating automation and integration can ensure that all current regulations are met at each point of the workflow.

An informatics platform that can integrate with existing software

The need for a platform in the pharma manufacturing sector that can interface with an organization’s existing software solutions is important to facilitate the secure, safe and fully traceable exchange of disparate data types across laboratories throughout a product’s lifecycle.

Instrument integration reduces the need for manual recording, such as transferring data from one system to another, which negates the potential for errors, gives back operator time and reduces data redundancy. Today's informatics platforms allow us to look at results with a greater depth of business intelligence. You can look at result trends and mine historical data to understand how issues arise so that protective measures can be put in place. However, these kinds of retrospective and predictive analytical approaches can only be carried out when you have all your data and metadata available in context.

Through scientific data management systems (SDMS), customers have the ability to aggregate their data and produce an audit trail from their original sample through all the instrumentation, and make actionable decisions based on that data for quality purposes.

New platforms allow infrastructure upgrades without changing user experience, therefore limiting the amount of user training that is necessary. Modern LIMS solutions can evolve together with organizations, allowing them to take advantage of technological advancements and tailor to their organizational configuration, business model or any changes driven by regulations or procedures.

Accelerating the development of new product capabilities with increased efficiency

Sophisticated analytics suites and visualization tools are paramount in the quality control arena. Laboratories are transforming into predictive rather than reactive environments with the use of artificial intelligence and guided algorithms that can anticipate where potential and actual process, instrument or workflow faults lie, based on real-time data.

Predictive modeling tools built into modern LIMS ensure quality and expedited turnaround time by identifying problems before manufacturing or testing has to stop. These insights give the pharmaceutical industry the ability to quickly identify areas for improvement or resolution.

Informatics platforms are inherently good at flagging for deficiencies that must be addressed, particularly for guiding scientists to follow procedures step-by-step. The use of an electronic lab notebook (ELN), for example, makes it possible to enforce the execution of methods as prescribed, and capture all procedural and results data and metadata through the LIMS. This way, platforms can effectively enforce the consistency of what is documented and how it is documented.

The bottom line is compliance and data integrity

Laboratories need to have a quality management system as well as a laboratory management system in place to document equipment maintenance and quality control and to limit the need for studies and calibration records. Does your process of reagents and standards link to the performed analytical methods? The ability to verify that the product you are manufacturing meets quality standards and has been manufactured according to all regulatory requirements allows your data to be defensible. This is critical for any laboratory operating in a regulated environment, regardless of the industry.

Data must comply with ALCOA principles laid out in the FDA guidance. Whether recorded manually or electronically, it must be attributable, legible, contemporaneous, original and accurate. These principles should influence all data throughout its lifecycle. Digital transformation will help make compliance an easier task for vendors and will ultimately lead to higher-quality products in the pharma market.  

About the author

Mark Spencer, Divisional Vice President and General Manager at Abbott Informatics

Mark is Divisional Vice President and General Manager, Abbott Informatics, where he leads the STARLIMS software and analytics business based in Hollywood, FL. He was appointed to his current position in January 2016. Prior to joining Abbott, Mark  served as President, QualityStar LLC a software startup in pathology informatics and a portfolio company of Prairie Ventures. Mark  has held general management and roles with increasing responsibility at CareFusion, McKesson and Sunquest Information Systems. He earned a bachelor's degree in computer science/management information systems from Park University and is a six-year veteran of the United States Air Force.