Posted on Lab Informatics. 5 June, 2019
Modern laboratories in all industries are under intense pressure to reduce costs and improve operational efficiency, while at the same time enhancing quality and maintaining regulatory compliance. Additionally, the rise of R&D externalization strategies and contract research organizations (CROs) in the pharmaceutical industry has resulted in labs collecting large amounts of data from multiple partners, leading to a significant increase in laboratory workflow complexity.
Informatics solutions, such a Laboratory Information Management System (LIMS), have been widely adopted across industries in order to meet these challenges. Traditional on-premise architecture for these systems, however, is often time-consuming and costly to implement and manage. The time that internal IT spends managing infrastructure, integrations and upgrades impedes a company’s agility and ability to innovate. Additionally, on-premise systems often fail to provide the scalability that is necessary to remain competitive in today’s challenging economic environment. The reality is that many companies are struggling with on-premise systems that are not responsive, connected or agile.
In recent years, a number of informatics vendors have begun to offer LIMS as an outsourced service in the cloud, with the LIMS located on the provider’s or third-party servers. According to a recent LIMS Market Analysis Report by Grand View Research, cloud-based LIMS accounted for the largest share in the market in terms of revenue in 2017. In addition, the report concluded that cloud-based LIMS are expected to post the highest compound annual growth rate (CAGR) through 2025. Let’s explore the benefits of cloud-based LIMS, along with some important factors to consider when making the move to the cloud.
With the digital revolution driving the pace of change in the global economy at ever increasing rates, it is more critical than ever for laboratories to develop, test, deploy and maintain effective IT solutions in a cost and time sensitive manner. 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 enhancing systems for innovation. Moving to an SaaS LIMS solution offers a number of potential benefits for your organization:
Reduced Costs. With an SaaS LIMS, there is typically a minimal installation fee, no license cost, no need for in-house servers or databanks to house the company software or data, and no IT maintenance costs for either hardware or software. You simply pay as you go with a subscription-based model – you only need to pay for the features you need. As there is no large capital expense associated with an SaaS LIMS, funds can be used instead to invest in your core business to fuel the innovation necessary to keep your company competitive.
Faster LIMS Implementation. There is no need to invest in and set up servers, and install the software. With an SaaS LIMS, much of this work has already been done, and your lab can be up and running on the new LIMS relatively quickly.
Automatic Software Updates. With an SaaS LIMS, your service provider takes care of any necessary software or security updates or patches to keep your system up to date. This frees up a significant amount of time and effort from your IT department, allowing them to focus efforts on other laboratory initiatives that add value to your business.
Flexibility. Cloud-based LIMS are ideal for organizations with fluctuating user demand. SaaS makes it easy to scale your service either up or down, depending on what is going on with your business, and you only pay for what you use. New users, features and services can be all added at the click of a button. The agility that SaaS provides can give businesses using cloud-computing a real edge over their competition.
Backup and Disaster Recovery Services. An effective disaster recovery plan is critical for your business. The cloud-based backup and recovery solutions that come with an SaaS LIMS are provided without the need for a large up-front investment, making these crucial data protection services accessible to businesses of all sizes.
Collaboration and Accessibility. Cloud-based LIMS supports easy, hassle-free access to your data anywhere (from multiple locations, multiple systems, and multiple branches) and anytime with a secure login ID. This facilitates improved collaboration between laboratories in global organizations, as well as the ability to access data and workflows from wherever you have an internet connection. And with many cloud services offering mobile apps, you’re not restricted to a particular device to access the system. In contrast, on-premise systems only allow access from the lab and often store information in silos, making it difficult to have a complete, real-time view across the organization.
Security. While some organizations in highly regulated and competitive industries are still somewhat hesitant to let their sensitive data outside of their own firewalls, the data storage in the cloud has actually become quite safe and reliable. Many banks and financial institutions have already made the move to the cloud. Cloud based LIMS data is fully encrypted when stored and only accessible with a secure login. Additionally, cloud-based systems allow large enterprises work with partners (e.g., CROs) without having to punch a hole in their firewall. The partner can simply be given access to the database in the cloud for the duration of the project.
Levels the Playing Field. A cloud-based LIMS allows small businesses have the ability to access enterprise-level functionalities and features on a pay as you go model. As a result, a small business running an SaaS LIMS can actually be more nimble and agile than a large enterprise that is still working on an on-premise legacy system.
HIPAA Compliance for Regulated Laboratories. A cloud-based LIMS allows protected health information to be safeguarded following HIPAA guidelines. An encrypted, HIPAA compliant cloud environment is available from most SaaS LIMS providers.
While an SaaS LIMS offers the potential for significant benefits, it isn’t necessarily the best option for every laboratory. One potential drawback of an SaaS LIMS is that it can be more difficult to customize the system beyond the vendor’s supported configuration options. Implementing an SaaS LIMS in a large enterprise that already has a highly customized on-premise LIMS being maintained by a skilled in-house IT team is probably not the best choice. Migrating such a system to the cloud would be a significant undertaking and may end up resulting in a system that falls short of the laboratory’s requirements. If you have a talented IT department that can handle system upgrades and data security, or if you need a highly customized LIMS for your laboratory, it may be prudent to stick with an on-premise solution.
Other factors that need to be considered when working with an SaaS LIMS provider include:
Security. When working with an SaaS LIMS, you will be relying on the service provider to protect your data as it moves into the cloud. Most cloud providers do a great job these days of providing a secure environment for your data – the biggest vulnerabilities are usually more related to human nature (e.g., phishing attempts) than technical weakness. While the risk of a data breach is usually very small, some companies in heavily regulated industries are still hesitant to allow their data to move beyond their own firewall. You’ll want to thoroughly evaluate the security policies of your provider to ensure that your data will be adequately protected before committing to an SaaS LIMS. Does the cloud provider employ state-of- the-art firewalls, malware detection, virus security, and intruder detection technology? Is the LIMS data encrypted both during transfers and while at rest?
Hosting Options. Some providers offer the option of a private cloud that is hosted within your facility. This option provides many of the benefits of an SaaS LIMS (public cloud), but with reduced security risks. A cloud can be public, either as single-tenant or multitenant, or can be private. In practice, a single-tenant cloud is much easier to validate and is less prone to data leakage or intrusion.
Validation. The ultimate responsibility for compliance with all regulations always rests with the manufacturer. While many vendors leasing a cloud-based LIMS advertise a “prevalidated” system, this normally refers only to the cloud provider and their systems. You’ll want to make sure you understand exactly what the vendor means by prevalidated and what scope that covers, so that you can be sure the system is also properly validated in the user environment.
Additionally, SaaS LIMS providers typically handle all software upgrades and patches to ensure that you are always running the most recent version of the system. Given that any change to the system renders previous validations void, you’ll want to make sure you understand who is required to handle revalidation after an upgrade to ensure that the system stays in compliance?
Audit Trails and Data Integrity. An immutable audit trail is critical to address data integrity concerns, both from a regulatory and product quality perspective. You’ll want to make sure that your SaaS LIMS has a reliable and detailed audit trail for all data, and that the audit trail is adequately maintained on a different server than the data itself. Additionally, you’ll want to make sure that your provider has their system default set to store a fully detailed audit trail, maintains detailed server and network logs, and provides third-party auditing insurance for their data center.
Integration. You’ll want to ensure that your SaaS LIMS has the capacity to integrate with your instruments and other informatics systems.
Business Continuity. You’ll want to understand how data backup and recovery are handled and who is responsible for it. Details of what the provider guarantees (hardware, service, uptime, response time, etc.) should be clearly stated in the service level agreement (SLA). Additionally, the SLA should clearly detail what backup and recovery services are included and which are optional, along with the costs incurred by employing these optional services.
Service Level Agreement. It is critical that you create an SLA with your provider that addresses all the above areas of concerns and more. A well-written SLA can make the difference between a smooth implementation and roll out of your SaaS LIMS versus cost and time overruns and unexpected expenses down the road.
In the last several years, technology providers have responded to market demand by developing cloud-based LIMS as an SaaS offering. Cloud-based LIMS help to facilitate improved connectivity, agility, scalability and innovation in the laboratory environment, all while helping to reduce costs and increase operational efficiencies.
Moving to the cloud, while simplifying some things, does add another layer of complexity to your business processes. As detailed in the previous section, there are a variety of questions that you need to make sure are asked and effectively answered in order to determine if an SaaS LIMS is right for your organization. The decision to deploy an SaaS LIMS will be guided by a mix of security, operational and regulatory concerns that are unique to each laboratory. Working with a quality informatics consultant is the best way to ensure that your organization gains the most value from this new SaaS approach to laboratory information management.
Astrix Technology Group has over two decades of experience in this domain. Our professionals bring together the technical, strategic and content knowledge necessary to help you efficiently select, configure, implement and validate a LIMS that will best meet your needs and keep your total cost of ownership low. Whether your LIMS deployment utilizes public, private, or a hybrid cloud architecture, our experienced and skilled professionals can make the process of implementing or migrating to an SaaS LIMS far more cost effective and efficient.
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