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ISO 20387:2018: The Key to Quality Biobanking

Author: Shonali Paul

Journal:, August 29, 2022

Abstract: In the last two decades, clinical research has grown exponentially; therefore, the demand for high-quality biological samples has increased, not to mention the last two years. The most recent pandemic has accelerated the need to optimize and automate processes to meet the evolving needs of modern research, especially in fields such as genomics, proteomics, precision medicine, and clinical research.

Digitization: Enabling Biobanks Navigate Through Regulatory Challenges

Author: Shonali Paul

Journal:, March 7, 2022

Abstract: Over the past two decades, there has been an increased need for collecting, curating, storing, and distributing biological specimens to gain specific information into the genetic makeup of diseases [1]. This has sparked the demand for biobanking.

Disease-Specific Biobanks: How Can a LIMS Help in Data Management?

Author: Shonali Paul

Journal:, October 3, 2021

Abstract: Biobanks have a fundamental role to play in ensuring successful outcomes in clinical research by providing quality biosamples. They host donations of biological materials such as cells, DNA, and tissues. They also handle data that is related to the biosamples.

Safeguarding Viability and Efficacy of COVID-19 Vaccines: Key Considerations

Author: Shonali Paul

Journal: Technology Networks, July 7, 2021

Abstract: While getting vaccinated against COVID-19 is not a guarantee that one will not get infected or re-infected by the virus, it is definitely among the most effective ways to forestall the pandemic. COVID-19 vaccines bolster the immunity of vaccinated individuals and when conducted en masse it helps to provide herd immunity. Consequently, vaccine development and deployment is a top priority for most governments at this point.

Biobanks – A Platform for Modern Biomedical Research

Author: Shonali Paul

Journal:, April 16, 2021

Abstract: Without biomedical research, medicine, as we know it, would be nothing more than a machine gun affair. In simpler words, biomedical research is the substratum that supports evidence-based medicine. Biomedical researchers study biological and pathological processes in order to prevent and treat disease effectively.

Struggling to Zero in on a Biobanking LIMS? Here is the Checklist of Essential Features To Consider

Author: Shonali Paul

Journal: Technology Networks, February 25, 2021

Abstract: This year, more than ever, has underscored the critical services that biobanks provide to biomedical researchers and other scientists. Biobanks are complex operations that manage thousands, or even millions, of biological samples and associated data required for scientific research.

ISBER Best Practices Recommendations for Biobanks and Biorepositories

Author: Shonali Paul

Journal:, March 16, 2020

Abstract: Biorepositories provide essential support to biomedical researchers by collecting, processing, storing and distributing millions of biospecimens every year. Biorepository staff must navigate complex international regulatory rules governing the use of biospecimens and protected health information. The International Society for Biological and Environmental Repositories (ISBER) aims to make this easier with it’s comprehensive Best Practices Recommendations for Biorepositories.

LIMS Evaluation Guide – 10 Pointers Ahead

Author: Shonali Paul

Journal:, October 29, 2019

Abstract: The primary objective of a biobank is to provide efficient management of samples and their associated data and thus saving valuable time and effort of researchers. Samples without accurate and reliable data may yield insignificant outcomes and therefore, not useful for research. Thus, it is important to maintain a complete chain-of-custody of the samples along with their non-identifiable subject information. Biobanks offer high-quality samples with well-documented procedures to ensure that the samples are stored in a controlled environment.

3 Top Cloud-Based LIMS for Biobanks

Author: Shonali Paul

Journal:, August 8, 2019

Abstract: A biobank is an entity that stores high-quality biospecimens along with their clinical data such as demographic information, personal medical history, and lifestyle information. Biobanks also ensure that biological specimens are kept in a controlled environment and guarantee that they are collected complying with ethical and legal regulations.

Biospecimen Quality in Clinical Research

Author: Shonali Paul

Journal:, February 11, 2019

Abstract: Biospecimens form an integral part of many clinical research studies. The production of valid clinical data sets depends largely upon the quality of biospecimens utilized in the study. Annotations of biospecimens help unveil information related to disease prognosis, diagnosis, and treatment. However, there are several stages including collection, processing, and storage through which a biospecimen travels before its utilization in research.

Reasons for Choosing a SaaS LIMS for a Biobank

Author: Shonali Paul

Journal:, November 5, 2018

Abstract: With the growing acceptance of LIMS by laboratories, there also exists a continuous dilemma on how to zero-in on a LIMS that is efficient, flexible, and scalable to accommodate the changing needs of a laboratory with time. A traditional on-premise LIMS requires a dedicated IT infrastructure, a skilled team of software programmers, and has a high cost and long deployment period.

The State of Cloud-Based Biospecimen and Biobank Data Management Tools (BRIEF REPORT)

Authors: Shonali Paul, Aditi Gade, and Sumani Mallipeddi

Journal: Biopreservation and Biobanking (BIO)
Volume 15, Number 2, 2017; Mary Ann Liebert, Inc.; DOI: 10.1089/bio.2017.0019

Abstract: Biobanks are critical for collecting and managing high-quality biospecimens from donors with appropriate clinical annotation. The high-quality human biospecimens and associated data are required to better understand disease processes. Therefore, biobanks have become an important and essential resource for healthcare research and drug discovery.

Delineating the Nuts and Bolts of the USDA’s Hemp Testing Rules

Author: Martha Hernández

Journal: Cannabis Science and Technology, January/February 2023

Abstract: Hemp was legalized federally in the U.S. when the 2018 Farm Bill was passed. However, due to the close relationship between hemp which is legal, and cannabis which is not, the hemp industry is strictly regulated by the federal government.

9 Federal Rules You Must Know Before Setting up a Hemp Testing Lab

Author: Martha Hernández

Journal: Labcompare, December 13, 2022

Abstract: Hemp testing is a new and seemingly lucrative niche that several laboratories are looking to venture into. From an economic standpoint, there’s every reason to venture into the industry at this point when the market is still evolving and the economic potential is huge.

Cannabis Extraction Facility Setup: The 7 Success Factors

Author: Martha Hernández

Journal: Labcompare, November 8, 2022

Abstract: Setting up a cannabis extraction lab can be an exhilarating experience, especially if you’re passionate about the cannabis industry, because extraction is where all the goodness of cannabis is revealed. The global cannabis extract market was valued at $2.74 billion in 2021 and, with a projected CAGR of 20.6%, it is expected to hit close to $3.5 billion by 2030.1

7 Factors For a Seamless Cannabis Extraction Lab Setup

Author: Martha Hernández

Journal:Analytical Cannabis, October 12, 2022

Abstract:Cannabis extraction and testing have become fundamental pillars supporting the transition of the cannabis industry from an illicit market to a legal one. According to a recent Grandview Research Report, the value of the global cannabis extract market stood at $2.74 billion in 2021. The market is projected to grow at a rate of 20.6% to attain a value of $15.5 billion by 2030.

Starting a Cannabis Extraction Lab? Here Are Some Key Considerations

Author: Martha Hernández

Journal: Cannabis Industry Journal, July 14, 2022

Abstract: Cannabis sativa contains over 500 different bioactive compounds that can be separated through an extraction process. This is carried out in an extraction lab and the end result is the production of cannabis extracts with a high concentration of specific cannabinoids (such as THC or CBD) with up to 99% purity levels.

The USDA's Hemp Testing Rules Have Changed. Are You Ready?

Author: Martha Hernández

Journal: Analytical Cannabis, March 21, 2022

Abstract: Testing is a crucial aspect of the hemp industry; it stamps the legality of hemp in the US. But the testing rules have changed yet again. Is your lab ready to absorb the new requirements?

USDA’s Hemp Testing Rules: Fast Track Your Lab’s Preparedness with Digitization

Author: Martha Hernández

Journal: Cannabis Industry Journal, March 9, 2022

Abstract: Learn about the USDA’s new federal hemp testing rules & how a Laboratory Information Management System (LIMS) can digitize operations to fast-track your lab’s preparedness.

Five Steps to Prepare Cannabis Testing Laboratories for ISO 17025 Audits

Author: Arun Apte

Journal: Cannabis Science and Technology, February 3, 2020

Abstract: This tutorial article outlines some of the steps that cannabis testing laboratories can take to prepare ahead of a third-party safety audit. It discusses several practical measures that facilities can take to boost their chances of passing an audit, including advice on time management, essential employee training, and laboratory management systems that can ensure a smooth and seamless audit process.

Managing Cannabis Testing Lab Workflows using LIMS

Author: Dr. Susan Audino

Journal: Cannabis Industry Journal, February 7, 2018

Abstract: With the increasing legalization of both adult recreational and medical cannabis, there is a need for robust and reliable cannabis analytical testing to ensure consumer safety and drug potency. Cannabis testing laboratories receive high volumes of test requests from cannabis cultivators for testing quantitative and qualitative aspects of the plant.

Using Cloud-based LIMS to Improve Efficiency in Cannabis Labs

Author: Shonali Paul

Journal: Cannabis Industry Journal, November 10, 2017

Abstract: With the increasing legalization of both adult recreational and medical cannabis, there is a need for robust and reliable cannabis testing to ensure consumer safety. The existing cannabis testing labs are receiving huge numbers of test requests from cannabis growers and manufacturers for potency testing, terpene profiling, pesticide screening, residual solvent screening, heavy metal testing, microbial analysis, and genetic testing.

LIMS in Clinical Trials Sample Management

Author: Shonali Paul

Journal: Journal for Clinical Studies, October 28, 2019

Abstract: In the 1980s, during the nascent era of laboratory information management systems (LIMS), major analytical instrument manufacturers figured that producing software to help acquire information from those devices while managing lab samples might leverage sales of those high-margin instruments. Since that time, many so-called “Pure Play” LIMS vendors have emerged. Shonali Paul at ISBER demonstrates how LIMS has evolved in clinical trials sample management over the years.

Data Sharing Solutions for Biobanks for the COVID-19 Pandemic

Authors: Shonali Paul and Mrinal Kanti Chatterjee

Journal: Biopreservation and Biobanking (BIO)
August 19, 2020; Mary Ann Liebert, Inc.; DOI: 10.1089/bio.2020.0040

Abstract: The coronavirus disease 2019 (COVID-19) is a novel illness, which is not fully understood. Whether an individual has traveled outside their respective country or never left their community, COVID-19 is a highly contagious illness, which can result in high death rates. Biobanks will play a role in providing tools to examine data from those receiving treatment along with reviewing the current and long treatment outcomes associated with this novel coronavirus disease. A diverse, global network made up of laboratory scientists, clinical researchers, epidemiologists, data science teams, physicians, and so on must have a standardized, collaborative, virtual biobanking solution to share clinical expertise and evidence-based solutions.

A Guide to Setting up a Coronavirus (COVID-19) Clinical Diagnostic Testing Laboratory

Author: Shonali Paul

Journal: Clinical Lab Manager, May 29, 2020

Abstract: There is an urgent need to set up new COVID-19 diagnostic testing labs and put procedures in place for existing labs to handle the new COVID-19 testing processes. The Centers for Disease Control and Prevention (CDC) provides specific guidelines on how best to collect, handle and ship COVID-19 specimens. The CDC provides current guidelines related to laboratory biosafety and COVID-19.

Current and Upcoming SARS-CoV-2 Diagnostic Tests: Everything You Need to Know

Author: Shonali Paul

Journal: Lab Manager, May 06, 2020

Abstract: A major challenge concerning the COVID-19 virus is its detection. While the general public is frustrated at the length of time required for COVID-19 testing or developing new test methods, those in the scientific community understand that this is due to the construction of viruses in general, and the logistics of testing thousands of COVID-19 specimens.

Safety for Biobanks: Strategies for Safe COVID-19 Specimens Handling

Author: Shonali Paul

Journal:, April 24, 2020

Abstract: The COVID-19 pandemic has spread to almost every country around the world. In less than 4 months, this new disease has affected more than 1,800,000 people and caused almost 120,000 deaths. There are no effective treatments or vaccines for COVID-19. Therefore, while scientists search for therapeutic options, many governments have turned to patient testing and contract tracing to control the outbreak.

Is Your Food Testing Lab Prepping for an ISO/IEC 17025 Audit?

Author: Arun Apte

Journal: Food Safety Tech, October 20, 2020

Abstract: With the increasing globalization of the food industry, ensuring that products reaching consumers are safe has never been more important. Local, state and federal regulatory agencies are increasing their emphasis on the need for food and beverage laboratories to be accredited to ISO/IEC 17025 compliance. This complicated process can be simplified and streamlined through the adoption of LIMS, making accreditation an achievable goal for all food and beverage laboratories.

Psychedelics 101: The Emergence, Regulatory Framework, & the Need for Quality Testing

Author: Martha Hernández

Journal: Analytical Cannabis, March 15, 2022

Abstract: We live in a world plagued by mental health diseases, which only seem to magnify each year. Conditions like addiction, depression, anxiety, and post-traumatic stress disorder affect a large swath of the population – according to a 2017 study, depression alone affects over 4.4 percent of the global population – and current events like Covid-19 don’t tend to help matters.

Is SaaS LIMS Right for Your Laboratory?

Author: Shonali Paul

Journal: Lab Manager, August 26, 2019

Abstract: Software as a service (SaaS) is a term that is not only in vogue now, but every indication is that SaaS applications are here to stay. It wasn’t that long ago that a SaaS application model was met with a high degree of skepticism, and rightly so. A few decades ago, network reliability was at best questionable and companies demanding fast and high-availability of data on distant servers were few and far between.

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