What is a Biobank Information Management System (BIMS)?

Specifically designed for biobanks and biorepositories, a BIMS provides an ideal solution to manage and track samples. A BIMS records and manages donor information, including donor consent. It keeps records of all specimens whether in process, storage, or shipment. Along with collecting, storing, and processing specimens, it also supports ISBER Best Practices recommendations and biobanking regulatory requirements. A BIMS not only helps in the secure management of sample and patient data but also assigns role-based access to authorized users, removes data silos, and generates personalized reports.

Importance of a Biobank Information Management System (BIMS)

Biorepositories are a key element in a growing number of organizations in biotechnology, pharmaceutical, and clinical research. Biobanks need to follow stringent regulatory guidelines and have data security measures in place as they contain biological samples from different sources and also sensitive patient data including their medical records and demographic information. The set-up and operation of a biobank also require legal, ethical, and safety considerations that not only pose challenges in managing the vast amounts of data collected from biosamples but also ensuring compliance with the regulatory requirements, such as HIPAA, 21 CFR Part 11, ISO 20387. Apart from this, biobanks also face numerous challenges such as managing biospecimens and patient data, tracking stored samples, automating workflows, assuring sample integrity, and following regulatory guidelines. This calls for the necessary safety framework, standardization, and harmonization of sample collection, processing, and storage protocols. Deploying a robust and configurable biospecimen management system to manage biobanking data and meet workflow automation requirements can assist biobank managers in streamlining day-to-day processes, ensuring reproducibility and traceability of workflows, and thereby preserving sample integrity.

Top Factors for Choosing a BIMS

Biobanks differ in size or capacity. Additionally, the set-up and operation of a biobank require various legal and ethical considerations. To make sure you choose the right one, we have enlisted the crucial factors to consider before deciding on a biospecimen management system. Primarily, it is best to spend some time brainstorming about the most significant issues and the pressing needs as well. The very first we could consider is,

1. Data Management & Collaboration

The essential task of any BIMS is managing samples and associated metadata. Biobanking nowadays is as much about data storage and management as it is about the storage of high-quality samples. With the increase of omics technologies and incoming samples, biobankers have observed an exponential increase in data generated per sample. Since each new technology comes with its own data processing peculiarities, it also accompanies diverse file formats. Therefore, a good BIMS must have the functionalities required for sharing different file types to address the needs of all collaborative partners. Apart from this, it is also necessary to keep in mind the personalized data management needs of your biobank. This may include getting a comprehensive or specific overview of the biobanking processes, the need to quickly trace records, or the need to collect comprehensive information on not only samples, but also patients, questionnaires, or protocols.

2. Scaling Options

Once a streamlined data flow is ensured, it is important to consider what scaling options does the software offer. Many times biobanks exist in organizations that also conduct clinical trials or pre-clinical research. In such cases, the data management process is more challenging since it involves the harmonization of data types from multiple sources to setting up and automating necessary workflows to streamline various processes. Hence, it becomes necessary to ensure if your biobanking software meets the complex and diverse data management needs of your biobank. A biobanking LIMS must also have the option to add or remove users when you scale your operations. It is best to choose a system that could be upgraded seamlessly according to the requirements of your biobank.

3. Data Integrity Features

In a biobank, the sample data commonly change over time. To track sample data changes, a BIMS must be able to capture and record every change made by all users to every sample record with a date and time stamp. A biobank must retain a history of its sample data changes to support data accuracy.

A biospecimen management system functions more effectively when it is integrated with other systems and applications in a biobank. Instrument and software integration facilitates data interoperability between different systems, eliminates data redundancy, and automates workflows. It also improves the data quality and integrity by eliminating transcription errors. It saves a lot of time as every process is automated. A BIMS must be integrated with software such as Laboratory Information System (LIS), Electronic Medical Records (EMR), temperature monitoring systems for smooth management of samples and associated data.

4. User-Oriented

Before zeroing in on a biobank management software, it is worth considering the opinion of all users. An effective BIMS should be easy to learn and intuitive to navigate, accessible to users outside the organization for easy collaboration, and have the functionality to assign different role groups with varying permissions and restrictions. Each biobank should map out all potential users who could be lab technicians, coordinators, lab managers, and evaluate if a BIMS can meet the distinct requirements of all users. A correctly chosen BIMS ensures maximal efficiency at all stages of the biobanking processes by aligning with users’ convenience and requirements.

5. Privacy, Security, and Compatibility

In addition to serving research needs, biobanks also need to comply with necessary regulatory requirements such as HIPAA, ISO 20387, EU GDPR, and others. Patient privacy is of utmost importance for biobanks as they not only store sample data but also maintain donor data. Hence, it is crucial to choose a biospecimen management system that allows the sharing of information with researchers intending to use the samples for research without compromising data security and privacy. Although patient privacy must be maintained but not at the expense of limiting sample availability. A good BIMS should therefore address confidentiality issues while ensuring a secure chain of custody and efficient data sharing among collaborating research institutions.

6. Research and Networking

Current research practices frequently involve collaboration with contract research organizations (CROs). Biobanks and biorepositories need to make sure that they provide high-quality services to these organizations in a cost-effective manner. Deploying a unified system also smoothens the flow of information and communication. Furthermore, a system can be configured to meet the evolving demands and enable efficient data transmission in addition to ensuring procedural compliance.

Conclusion

Choosing a BIMS for sample management at your biobank could be a complex and time-consuming process. Although there may be features that may not contribute much value, certain key features are essential when it comes to choosing a biobanking LIMS software. An effective BIMS should be configurable according to your specific needs so that it can capture any data elements and data fields related to your samples. It should be able to record the precise location of every sample in your biobank. Biobanks usually have numerous samples and hence a good BIMS should enable you to create and batch update a considerable number of sample records. A biospecimen management system should maintain a record of the history of every sample information, be it freeze-thaw cycle count, processing details, or storage location. This functionality is also essential to meet regulatory requirements. A BIMS should enable you to search and filter through samples to retrieve specific sample records, allowing you to easily and quickly respond to requests for specific samples. These crucial factors must be considered while selecting the right BIMS.

A LIMS system is a software-based solution which helps in hassle-free data management and workflow automation in various laboratories. It allows the effective management of samples and associated data. A LIMS streamlines workflows, tests, procedures, and assures accurate process control. A LIMS also helps in quality management and enables laboratories to follow regulatory guidelines and best practices. Furthermore, functions such as audit trail and automated tracking of laboratory activities over time are some of the key reasons why people use a LIMS and opt to go paperless.

What does a LIMS Software do?

The journey of a sample involves sample accessioning, processing, storage, testing, and disposal. A LIMS facilitates sample accessioning as soon as a sample enters a laboratory. It generates a barcode once the initial sample data is entered in a LIMS so that it can be simply scanned again by different staff members as and when required. Each user can scan the same code to ensure that the data is accurate and the process is on track. A LIMS can also schedule tasks, track tests, manage test results, and generate test reports or Certificates of Analysis (CoA). As a sample makes its way through the testing process, all the information is stored safely, securely, and in a common easy-to-access repository.

Figure 1. Steps involved in the functioning of a LIMS software. (Figure Courtesy CloudLIMS)

What Benefits Does a LIMS Software Offer?

1. A LIMS offers a lot of benefits in terms of laboratory data management, such as managing sample data, scheduling staff training, managing documents, such as Standard Operating Procedures (SOPs). A LIMS also helps in maintaining quality control test results to support the validity of the actual test results.

2. It eliminates transcription errors through instrument integration. Instrument integration enhances laboratory efficiency and saves a lot of time by facilitating the automatic bi-directional transfer of data between analytical instruments and a LIMS, eliminating manual intervention. Instrument integration is a key factor in enhancing productivity and maintaining data integrity in a laboratory environment.

3. A configurable LIMS helps to mirror laboratory workflows, assign tasks to competent staff, distribute the workload among staff members, track the progress of tasks, and monitor the turnaround time.

4. Apart from all the other benefits, the topmost benefit that a LIMS offers is that it supports regulatory compliance including HIPAA, 21 CFR Part 11, ISO/IEC 17025:2017, ISO 15189, EU GDPR, ISO 20387, etc.

What is the Role of a LIMS Software in a Laboratory?

1. Through sample management, a user can efficiently track samples and allocate storage locations to samples.

2. A LIMS facilitates laboratories to manage the tests conducted on a batch of samples and their results, track approval or validation of results, generate reports, and share them with customers.

3. A LIMS helps protect confidential data through secure and restricted access to the data. Easy data backup is another important benefit.

4. An authorized user can easily and quickly generate various reports using the data stored in a LIMS.

5. A LIMS system streamlines the billing process by generating invoices and integrating with third-party billing and insurance software.

6. Laboratory tasks must be performed by trained and competent staff which is important for generating accurate and reliable results. A LIMS helps manage staff training and their competency. During audits, laboratories may need to produce records of staff training.

 Figure 2. Advantages of a LIMS system

A LIMS manages precise records of each sample and stores it securely, thus preventing loss of data as it is transferred between various departments. A LIMS system can generate automatic reorder alerts in case of stock depletion and manages stock supplies and reagents. It prevents any delays resulting from the unavailability of stocks. A LIMS alerts laboratory managers when any equipment is due for calibration or maintenance.

Who Uses a LIMS Software?

Laboratory technicians, managers, or directors from various industries, such as Clinical Research & Diagnostics, Biobanks, Food & Beverage, Cannabis, Oil & Gas, and Agriculture use a LIMS to manage their laboratory data.

Conclusion

Laboratories generate large amounts of valuable data daily. It becomes essential for them to track samples and associated data and use that to generate Certificates of Analysis (CoA), management reports, and other information-based insights. A LIMS contributes to the smooth management of laboratory workflows and efficient organization of the collected data. The overall operational efficiency of a laboratory can be improved by implementing a laboratory information management system (LIMS). It saves time otherwise spent on manual data logging and maintenance and offers an efficient data management solution. This prevents human errors and gives a more accurate information system to support multiple decisions. An audit trail automatically records laboratory activities that can be produced before regulatory authorities whenever required. Furthermore, a LIMS is most useful when dealing with voluminous data that requires batch analysis and repetitive daily operations. Furthermore, it also helps laboratories in maintaining regulatory, safety, and privacy standards.

In the following blog discover the advantages of a Laboratory Information Management System (LIMS) for your lab, and explore the benefits of using a configurable free LIMS solution FreeLIMS.

Most laboratories across the world are grappling with a data deluge and are constantly looking for ways to effectively manage data. With the rapid advancement of technology, old school laboratories have now modernized. Modern laboratories need to store huge amounts of data, automate workflows, and meet evolving regulatory requirements. Hence, laboratories have now switched to advanced data and quality management tools, one of which is, Laboratory Information Management System (LIMS). There are various advantages of using a LIMS system that chiefly translate into a faster turnaround-time and elimination of manual errors, resulting in higher accuracy. We will learn about all the advantages of LIMS in this blog.

What are the Benefits of a LIMS?

A LIMS is a database system for maintaining records of work or activities carried out in a laboratory with a date and time stamp. Sample tracking, traceability, data collection, workflow automation, and report generation are the major needs of any laboratory. Laboratory information system benefits include automating data entry processes, managing inventory, streamlining workflows, and assuring quality. A LIMS reduces time spent on locating samples and records, entering data, calculating results, and generating reports. Hence, a LIMS not only increases the efficiency of a laboratory but also the pace of research and analysis, assisting compliance with quality and regulatory standards at the same time.

What does a LIMS do for Laboratories?

Some of the ways in which laboratories have realized the benefits of a LIMS are as follows:

• Accessioning of samples as soon as they enter a laboratory.
• Tracking samples throughout the sample life-cycle.
• Managing Quality Assurance (QA) and Quality Control (QC) processes and recording associated data.
• Managing tests, test results, and flagging out-of-specification results to quickly identify abnormal observed values.
• Tracking inventory to reorder laboratory supplies and stocks for running tests and/or creating kits for for storing samples.
• Generating custom reports or Certificates of Analysis (CoA).
• Automating data transfer by integration with analytical instruments to avoid transcription errors.
• Monitoring the laboratory environment and recording data such as instrument calibration and maintenance, personnel training and competency records, customer details, non-conforming activities and resolutions to the issues reported by customers.
• Managing documents, such as Standard Operating Procedures (SOPs), tracking their revision history and controlling the access of documents to prevent unauthorized access.
• Following regulatory guidelines, such as ISO/IEC 17025:2017, ISO 20387, HIPAA, FSMA, 21 CFR Part 11, GDPR, GxP.

What are the Advantages of a LIMS?

Enhanced Efficiency, Productivity & Analytical Accuracy

A LIMS helps a laboratory go completely paperless by automating laboratory processes, thereby increasing throughput and ensuring data integrity. It minimizes turnaround times by the complete removal of manual processes. A LIMS helps retrieve the data quickly during regulatory audits, reduces human errors, and eliminates any possibility of data loss or false reporting. A LIMS also prevents the use of outdated or uncalibrated instruments for analytical testing, assuring accuracy and the quality of test results.

Automation

It is difficult to track samples without using barcodes, as the sample information has to be entered manually at every step of the analysis. A LIMS allows entering the critical information about a sample, such as the sample source, the date, time, and location of collection, and sample processing data.

Compliance with Regulatory Standards

The US Food and Drug Administration (FDA) requires an “audit trail” to track all laboratory activities. The activities should be tracked when a record is created, modified, or deleted. A LIMS helps in maintaining a read-only audit trail to comply with the regulatory guidelines. A LIMS automatically records all laboratory activities with a date and time stamp.

A LIMS also enables laboratories to authenticate key laboratory activities using electronic signatures, thereby complying with 21 CFR Part 11 guidelines.

Rapid Deployment

A Cloud-based LIMS eliminates the need to purchase and install expensive software or pay large amounts up front for hardware infrastructure. This reduces the deployment time, enabling laboratories to get started quickly contrary to an on-premise LIMS. Changes to the LIMS can be done remotely, and updates are performed automatically without the help of IT personnel.

Hence, using a LIMS can bring multiple benefits to laboratories such as improved efficiency, reduced costs, improved customer satisfaction, and better compliance with regulatory and quality standards. If you are looking for a LIMS system, you can sign up for FreeLIMS to seamlessly manage data and automate your laboratory workflows.

What is COVID-19?

COVID-19 or coronavirus disease is a highly infectious disease caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). The new virus was not known to infect humans before the outbreak began in Wuhan, China, in December 2019. COVID-19 has infected millions of people across the globe and has caused thousands of deaths.

What Happens When You Get the Coronavirus Disease?

People with COVID-19 generally develop signs and symptoms, including respiratory distress, dry cough, and fever, muscle pain, about 5-6 days after infection. In children, the disease may express itself with skin rashes, nausea, and diarrhea.

How Does COVID-19 Spread?

COVID-19 is mainly transmitted through droplets generated when an infected person coughs, sneezes, or speaks. The droplets can land on another person’s eyes, nose, mouth, or can be breathed in or a healthy person can touch them on a surface on which they are still live.

Biospecimens are biological materials such as urine, blood, tissues, cells, DNA, RNA, that are derived from humans, animals, or plants. Biospecimens are being collected and stored for a long time now to support clinical and research activities. A biorepository is a facility that collects, processes, and stores biospecimens.

Biospecimens from humans are stored and the associated patient information (for example, their medical history, social history, demographic details) are recorded to study a disease, develop a treatment plan, investigate the efficacy of drugs administered, or discover disease biomarkers. Hence, the purpose of establishing a biorepository is to make samples and associated data available to investigators. Biorepositories storing human samples are usually termed as biobanks. With the advancement of modern research and technology, biobanks have become an indispensable resource for research and the rapid development of precision medicine.

What is the difference between a biobank and a biorepository?

The term “biobank” has traditionally been used to refer to collections of human biological material, while “biorepositories” refer to collections of specimens from all living organisms. However, some groups have used the term “biobank” to refer to animal tissue repositories also, blurring the distinction between the two terms. The difference between “biorepository” and “biobank” has become increasingly unclear, and the terms are often used interchangeably.

Types and Uses of Biorepositories

1. Hospital-based biorepositories that support research by biomarker validation.
2. Biorepositories that are fully integrated with patient registries.
3. Biorepositories that identify genetic clues to help in therapeutic development.
4. Disease-focused biorepositories that majorly focus on understanding specific habits and practices.
5. Single & multiple study biorepositories that are developed to support a single study or multiple research studies.
6. Population-based biorepositories that help in improving the prevention, diagnosis, and treatment of serious diseases prevalent in certain regions.

Framework for Working in a Biorepository

1. HIPAA: A biorepository must follow HIPAA guidelines (Health Insurance Portability and Accountability Act) to safeguard patient privacy.
2. Informed Consent: Biorepositories store human biospecimens, hence it is required that the consent form is signed by the specimen donors as they have full right to withdraw authorization from using their samples.
3. Sample Custody: The custody of samples remains with the researcher who collected them or the biospecimen regulatory body.
4. Access to Biological Specimens: Biorepositories should maintain a read-only audit trail to regulate the internal or external transfer of samples, including access to compliant logs with FDA standards for records.

Operations of a Biorepository

1. Collection: Samples are accessioned in this step by scanning barcodes with a barcode scanner. The sample information is then entered into a Biobanking LIMS.
2. Processing: This step usually involves sample preparation for long term storage and also helps in reducing variations due to sample handling.
3. Storage: This step involves storing samples in boxes that are in turn stored in temperature-controlled freezers depending on the storage requirements.
4. Distribution: This step involves retrieving samples from the storage for shipment to researchers.

Standard Operating Procedures (SOPs)

The methods of collection, processing, storage, and distribution of samples must be standardized to maintain high-quality samples that are fit for research.

SOPs help biorepository personnel follow standard operating procedures for various biorepository activities.

SOPs can also help to provide minute information about the processes and storage methods that assure the quality of biospecimens. This ensures minimum variations in samples and assures their integrity.

Both the terms, biobanks and biorepositories, are often used interchangeably. However, it is important to differentiate between the two as biobanks store human samples and biorepositories carry samples of all living organisms including humans.

State tracking systems in cannabis testing are critical to cannabis businesses to comply with industry and state regulations.

Now, more than ever, cannabis companies are in need of customized, reliable software to maintain compliance with state-level cannabis testing laws. Laboratory Information Management System (LIMS) for cannabis companies helps with compliance requirements to manage and support traceability, and other state-level requirements.

Let’s break down the state tracking systems, how they’re impacting the cannabis industry, and how LIMS for cannabis is helping.

What do Cannabis Tracking Systems do?

Cannabis tracking systems are designed to monitor the growth, production, and distribution of cannabis products from seed-to-sale. They often require the tagging and tracing of each plant. Cannabis LIMS is designed to automate the workflow of cannabis business to comply with cannabis and state tracking systems at scale.

State regulations help ensure that clean products are making it to the marketplace, however, placing a burden on the cannabis testing companies.

The Difficulties of Cannabis Tracking Systems

The amoebic cannabis industry makes it difficult for business leaders to stay-up to date. Unfortunately, most business owners are not information system experts and this has a set of challenges. For example when Oregon’s cannabis regulations shifted in February in 2017 to enforce cannabis companies to include all of their QC data, many companies found themselves without a working framework of how to do so.

Software companies build state-explicit apparatus to enable their customers to follow the new state guidelines. Additionally, software has to address the legacy frameworks with a poor UI that does not encourage the work process of cannabis business pioneers.

Seed-to-Sale Software Solutions for Cannabis Businesses

Despite all the challenges faced in a nebulous set of regulations around the country, businesses have found ways to thrive using LIMS,and employing cannabis-centered SaaS for their information management.

The many benefits of this approach include:

• Customized reports for cannabinoid concentrations, pesticide levels, and more
• Flexibility in data models on an as-needed, or state-by-state, basis
• Real-time access to data-24/7
• Automated workflow processes
• Lowered costs
• Increased efficiency in account management
• Improved capabilities to implement product recalls
• Streamlined supply chain and inventory transactions

Do you need seed-to-sale software integration with your cannabis lab operations?

Sign-up for FreeLIMS for cannabis information management solutions!