While LIMS is a game-changer for the pharma industry, with the potential to dramatically increase productivity, reduce errors and ensure compliance with regulatory standards, many labs are lagging in terms of LIMS adoption. The reasons for this are far ranging, including from financial constraints to fear of change and a lack of understanding about the benefits of digitalization.
This article will explore the barriers to LIMS adoption, discuss the benefits and opportunities that such systems offer, and provide recommendations on how labs can navigate their digital transformation.
“With stringent regulatory compliances and greater responsibility toward societal healthcare development, pharma labs often overlook opportunities for digital growth.”
The thin line: Automation vs. digitalization in pharma labs
They are automated, not fully digitalized.
Although automation and technology have transformed the pharma industry, the digitalization of processes often remains at an early stage of maturity.
There are several reasons for this. In pharma, medical breakthroughs often take center stage, relegating software innovations to a secondary priority. Manufacturing processes are performed under stringent regulatory controls and close supervision at every stage to ensure high quality standards and compliance.
Why pharma plays it safe with LIMS and digital lab technology
With drug discovery and manufacturing as top priorities, pharmaceutical personnel sometimes overlook technological advances. Common misconceptions for a digital lab include:
- The assumption that higher setup costs are inevitable.
- Infrastructure constraints.
- Increased space requirements.
- Higher downtime risks.
- Psychological barriers and skills gaps.
- Overcrowding of staff.
- Negative impact on the staff’s morale.
For pharma, any change in processes and methods calls for numerous safety checks. So, when it comes to adopting modern technology, they like to play it safe.
The global laboratory informatics market, powered by the increasing use of LIMS in pharma labs, is expected to surge from $3.62 billion in 2023 to $5.25 billion by 2028, growing at a CAGR of 7.74%, according to Market Data Forecast. Despite the uptake of LIMS, complete digitalization remains aspirational. However, labs have already made significant progress, moving from no automation to partial automation, with sights set on achieving total automation.
LIMS in pharma labs: Digitalization limitations
Complete digital transformation amounts to an overhaul of currently traditional laboratories. It involves substantial upheaval, both internally and externally. Although the outcome appears promising, the process is time-consuming, requires dedicated resources, and demands trust to achieve the desired results.
The differentiating factors in LIMS
Digital technologies and LIMS systems face many uncertainties. A platform such as CaliberLIMS aims to address these challenges. Like other comprehensive LIMS, it includes a variety of features, and over the years, it has integrated modern upgrades to enable future-ready laboratories. However, labs face some concerns that block their digital pathways.
Higher short-term costs: Digitalization is a major investment. Its initial escalation costs for new hardware and system installations are high. In some cases, the budget of laboratory operations and maintenance is limited, diminishing the scope of digitalization. The authorities might also demand a clear illustration of return on investment from its implementation.
Infrastructure constraints: To accommodate digitalization in already functional labs, many changes must be made to the internal infrastructure. One of the major considerations is instrument integration. This may drive an unneeded exercise for the lab officials. Moreover, renovating lab spaces for digitalization has limited scope for old buildings.
The risk of increased downtime: Complex, automated systems invite a greater risk of system failure. Such critical failures would necessitate restoring manual processes for managing samples, analysis of specimens, and other laboratory functions. These unfavorable consequences are often magnified by lab officials.
Psychological dependence: The traditional mindsets find digitalization as a disruptive tool for manual skills. Deterioration of skills with time and inefficient resuming of manual functions in case of digital failures are long debated drawbacks. The digitalized systems somehow have not yet gained confidence in these manually overpowered lab systems.
Compliance issues: For pharma labs, compliance guidelines are very stringent. Every single activity is monitored for adherence to these guidelines. Any deviation from the standards can lead to FDA 483s. A digitalized system, if it is compromised, can disrupt compliance metrics and result in hefty fines.
Sample management: Every sample in a lab has a defined journey and life span. Through manual processes, these variations can be clearly identified and maintained. Moreover, the stability of samples within digitalization is questioned. Contamination, collision, and inappropriate test results of samples are some of the concerns lab officials come across.
Audit failures: Regulated industries, especially pharma labs, are always under the lens. Audits are an integral part of their operations. Handing over responsibilities to software can feel risky for those accustomed to manual operations over a long period. While it is the other way around, getting over the habit is essential. Few lab officials might feel that it is ok to spend more time, double check entries, provide samples, and other data during audits.
Long-term benefits: Labs cannot afford to have temporary solutions. Their time and effort are precious. Digitalization solutions are not to be tried, tested, and discontinued. Many labs tend to avoid trying modern technologies with the concern of not being able to scale with future requirements.
How LIMS in pharma labs magnify opportunities
LIMS is an integral part of labs nowadays. However, for complete digitalization, labs could benefit from exploring robust LIMS systems designed with future needs in mind. While keeping it low on budget and infrastructure requirements, ensure that you have a system that easily fits in and has a trusted, global clientele. While most of the LIMS you find in the market are compliant with the regulatory requirements, it is important to check for scalability. Lab operations can vary due to market segmentation and demands. A LIMS must be capable of adapting to these uneven graphs at any given time.
Choose a comprehensive LIMS for next-gen labs
LIMS software brings in a paperless culture in labs. Progressive LIMS technologies have been designed to outgrow the current integration and innovation possibilities in labs.
With automated systems, compliance issues are non-existent. Plug-and-play modules allow labs to extract the full benefits of technology and thrive in this digital era. Configurable workflows, frameworks, and COAs make labs own their configurations. When the world is marching toward artificial intelligence (AI) and machine learning (ML), the right LIMS is the right start to infuse your laboratories with the fuel to fly high in the life sciences industry.
Progress in the digitalization journey
Modern LIMS have defied traditional lab operations’ odds and assumptions, setting new standards in the industry. The digitalization capabilities and user-friendly nature of these systems have proven that labs can achieve full automation and paperless operations without compromising on essential LIMS features. While LIMS software has been supporting laboratory functions for the past two decades, continuous upgrades and improvements are essential to stay ahead in a competitive environment.
Secure LIMS solutions could be a key part of preparing labs for the future. For users, a good LIMS maintains a balance between functionality and accessibility, enabling ease of use. This allows them to mold into the system seamlessly. A reliable LIMS is a blend of safety, security, stability and functionality all integrated into a single system.
Adcock exemplifies a commendable achievement by becoming India’s first 100% paperless laboratory. This was achieved by addressing the challenges and loopholes in the partial automation of their labs, making completely paperless lab a reality. To be successful in their digital transformation journey, labs must make the right decisions at the right time. Digital transformation is becoming a standard in the industry, and choosing the right partners for digitalization can make this journey smoother.
Labs must come out of the shadows. There is a brighter road ahead for pharma and life sciences. Technology can help accelerate lab processes, pave the way for future clinical developments, and lead to breakthrough discoveries. A thoughtful LIMS implementation can accelerate a lab’s paperless operations and operational excellence.
Filed Under: Data science