When Laboratory Information Management Systems (LIMS) were introduced in the 1980s, the focus was to provide a computerized solution for simple sample tracking, laboratory data storage, and reporting. With technological advancements and increasing demand for enhanced capabilities, LIMS has transformed from a simple software to a robust enterprise planning tool. Recognizing this trend, along with the seemingly lack of technological support in the rapidly growing space of biotech research and development (R&D), Benchling seized the opportunity to develop an innovative LIMS that is designed to accelerate scientific discovery and product development. Below, we take a deeper dive into the value of Benchling for research and development and explore its structure and applications: 

Infrastructure and Data Security 

Benchling offers a secure system that requires minimal IT resources to implement, which is ideal for companies that do not have sufficient IT investments. As a cloud-native platform, Benchling can maintain control over the security and compliance of its data and systems by enforcing measures such as network segmentation, firewalls, and traffic monitoring. External threats are minimized by isolation from the public internet and separation from the company’s corporate enterprise network. Accessing Benchling via a web browser allows data to be shared between sites and managed under one centralized access control policy. Customers have the option to configure access control via their own single sign-on (SSO) provider with multi-factor authentication (MFA) as an added layer of security. Data records within Benchling are encrypted with backups taken on a predefined frequency but only kept for a specific amount of time; therefore, it is important to establish a recovery and business continuity plan in case of system outage.   

Application of Benchling in R&D 

Benchling offers a full suite of applications for laboratory information management, such as sample registration, inventory management, electronic lab notebook (ELN), automated workflows, and data analytics. What makes Benchling unique is its Molecular Biology application that enables scientists to design, visualize, and analyze biomolecules via advanced tools and a modern user interface that empowers discovery research. This results in enabling complete documentation of protocol creation and execution that provides end-to-end traceability through linked sample and inventory records. Within a protocol, users can view real-time sample and inventory status to ensure that the appropriate materials and procedures are applied for each step. The protocol instructions followed by recording of results are captured as one entity that can be set up for review processes that involve multiple roles. Different organizations and teams across multiple sites can be created to control access to data while allowing collaboration work based on project assignments. From the R&D documentation and functionality perspective, Benchling delivers top-of-the-class capabilities. 

Application of Benchling in Product Development 

Beyond the R&D space, Benchling is well-positioned to manage multi-step processes, such as those in product development, via automated workflows. User defined templates can be created based on standard operating procedures (SOP) to capture instructions and execution of tasks for a procedure. Various procedures can then be grouped into a workflow to model a full end-to-end process flow. Utilization of workflows dramatically improves process visibility and collects valuable data for analysis. Such data can be organized and transformed into graphs and tables on a dashboard to measure productivity, forecast workload, identify areas for improvement, investigate recurring issues, and much more.  

Application of Benchling in Production 

Quality and compliance play an increasingly important role as a product transitions from small development scale to growing production needs. Benchling incorporates some basic compliance functionalities, such as version control, complete audit trail, and electronic signatures that are compliant with 21 CFR Part 11 and Annex 11; however, it does not provide adequate support for quality control (QC) activities such as batch management, product specifications, and report generation. Therefore, Benchling becomes a less desirable option for companies that focus on larger scale production or commercial production that is held under strict regulatory requirements. 

System Maintenance 

With a validated cloud tenant account, Benchling provides validation documentation for each version upgrade. They have an established validation strategy detailing all the steps that Benchling is responsible for and what activities the client should complete to ensure the system remains validated after each release. Benchling’s qualification, testing, and validation approaches are aligned with industry best practices for FDA’s Computer Software Validation (CSV) and Computer System Assurance (CSA) guidelines. These measures significantly reduce the client effort in maintaining system compliance and minimize the risk of citations during an audit or inspection. Given that Benchling issues new releases on a quarterly basis, GxP facilities are strongly recommended to have procedures in place to complete validation activities in a timely manner to avoid being out of compliance. 

The Value of Benchling 

Benchling is a well-designed LIMS in the R&D space. Industries that focus on biomolecular innovation, such as gene/cell therapy, antibodies, proteins, and microbials, will appreciate Benchling’s unique capabilities in biotechnology. In addition to data security monitoring, Benchling adopts procedures that maintain regulatory compliance within the company and its LIMS. In facilities that perform routine QC testing on products and materials, Benchling is not currently the ideal option considering the lack of features to support QC operations; however, Benchling is a vendor worth keeping an eye on for QC over the coming years as they continue to work toward more robust QC-oriented functionality. 

If your organization is interested in implementing a LIMS but unsure about which one best suits your needs, consider reaching out to our LIMS professionals for guidance. 

Contributions by Tina Yauger