As the pharmaceutical industry continues to face new challenges such as increased competition and new technological demands, their laboratories across the globe are looking for innovative ways to manage ever-increasing amount of data. Data collected from experiments is the most valuable information that research laboratories can hold, however many still rely on paper-based notebooks to record protocols and experiments, keep track of results and log data analysis.
However, the volume of data being produced by laboratories can make this process very labor intensive, limiting internal efficiencies as well as cross-site collaboration and communication. Digital solutions, such as electronic laboratory notebooks (ELN), supplemented with other solutions such as scientific data management systems (SDMS) and laboratory execution systems (LES), allow laboratories to consolidate and integrate data across an organization. In recent years, informatics vendors have begun to offer ELNs as an outsourced service in the cloud, providing organizations with automated data collection and management processes, which in turn facilitates flexible collaboration, as well as other potential benefits. Regardless of size, location, and purpose, it is crucial that the data is collated and stored in a manner that keeps it secure, but also allows it to be used efficiently. Can cloud-assisted ELNs rise to the challenge?
Laboratories across the globe are all challenged with similar barriers to productivity such as outdated informatics tools and inefficient workflows. Implementations, upgrades and integrations of on-premise systems can be time-consuming, and result in in-house IT personnel having little time to work on new ideas. Written observations in paper-based notebooks are often transcribed incorrectly, and tests and experiments are frequently repeated due to previous data being lost or inaccessible.
This challenge is further compounded by budget constraints which see laboratories running with the same level of demand, but with fewer human resources. The lack of a central data access point is a significant challenge facing research and development (R&D) productivity. A central point of access allows researchers to clarify where team members should store and find data. When laboratory staff must rely on several different data distribution methods, productivity is significantly slowed. Hours are then lost due to poor data collection and reporting systems.
Digital platforms, such as a software-as-a-service (SaaS) ELN, can create a reliable and repeatable process for disseminating data, as well as improving data searches, by hosting all files in one location. More intuitive technology solutions can also reduce user frustration and ultimately increase job satisfaction, which leads to productivity improvements.
The time saved on administrative tasks by implementing an ELN system enables researchers to reach milestones faster while saving money. However, many ELNs are hosted locally which poses a problem for those that operate across multiple sites and, often, multiple countries, resulting in an array of data being generated that sits in separate silos. Data formats and applications are also frequently inconsistent, making it hard for laboratory members to store all their work in one place, and for managers to oversee it. ELNs go some way to alleviate these challenges, but the issue is further complicated when lab managers and directors are required to manage multiple teams, often in different places.
Nevertheless, the potential rewards are substantial. An organization using an advanced laboratory technology such as a cloud ELN in real time can take advantage of a seamless data workflow. Laboratory technicians can document data, team leaders review it and project managers can oversee activity and relate it to timelines and budgets, no matter where in the world they are. Links can be placed digitally between projects, and experiments and metadata attached, making searches faster and simpler. All this enables smoother feedback and keeps discussions within the context of individual experiments.
Cloud-based ELNs also facilitate improved collaboration between laboratories in global organizations, allowing data and workflow access from wherever you have an internet connection. For example, one team member can order reagents for an experiment and link them to a protocol. Users can see where an item was used across a list of experiments, making it easier to find data, troubleshoot any issues and establish the suitability of entities for different experimental tasks. The provider can also offer better traceability of data and procedures taken during experiments, meaning the cause of failed experiments can be tracked, ultimately reducing the number of these fails and enhancing laboratory output.
How do cloud-based systems help laboratories reach their goals faster?
Time and cost savings are two of the key reasons for organizations transitioning from paper-based laboratory processes to cloud-based digital systems. Automatic sample review eliminates the need to manually check all information, as a central laboratory can use the online interface to register and enter samples, specify tests, and check this has all been performed correctly.
Quantity of data is another hurdle that cloud-based laboratory management solutions are designed to overcome. Many analytical techniques, such as flow cytometry, generate a vast number of large raw data files, which often need to be retained and integrated in the documented experiment, to ensure a company’s availability for spot checks. Incorporating this data into a cloud-based ELN frees up user space by moving data into the cloud and makes it available as required.
An unalterable audit trail is critical to address data integrity concerns, both from a regulatory and product quality perspective. The Code of Federal Regulations Title 21 (21 CFR) Part 11 compliance stipulates experiment audit trails and digital signatures as a baseline requirement for cloud based ELN systems . For clinical data storage and management, ELN systems that are HIPAA-compliant may be required. Cloud-based ELNs ensure that time and date stamping for regulatory and intellectual property tracking is straightforward, due to the simplicity of tracking ownership of experiments and determining which team member inputted certain data.
Lab productivity in the future
In order to keep up with their competitors, labs need a user-friendly informatics system where individuals can store large amounts of data in a structured manner while maintaining regulatory compliance. Technology providers have responded to this need by developing solutions such as cloud-based ELNs to facilitate the homogeneity of data and high-quality standards – improving connectivity, scalability, and innovation in the lab.
This need for powerful, agile and flexible laboratory management solutions is only going to intensify. Cloud-based solutions provide proactive insights into data, allow better management of inventories, and help laboratories to manage their collaborations more effectively. The decision to utilize a SaaS ELN will be guided by a mix of efficiency, security, and regulatory considerations.
Reference: CFR – Code of Federal Regulations Title 21 Part 11 – Electronic Records; Electronic Signatures, April 2018, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11
About the author
Steve Yemm is CEO at BioData, a Digital Science company providing lab informatics products—including electronic lab notebook, lab inventory, chemical registration and biological screening solutions—to biopharmaceutical and academic life sciences organisations. The company’s solutions are powered by Labguru, a web- and cloud-based informatics platform. Prior to this, Steve held the position of vice president of sales at BioData and Digital Science and has more than 20 years of experience in selling and marketing solutions (software, services and automation systems) to science based companies.