LIMS Evaluation Guide – 10 Pointers Ahead

Figure : A Biobanking LIMS to track biospecimen location
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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. However, due to the increase in the number of samples generated in the past decade, biobanks are under constant pressure to undertake significant streamlining initiatives to process and store the samples more robustly and efficiently. Despite the numerous efforts, resources, and budgets dedicated to biobanks for sample management activities, it is still challenging to establish a complete, consistent, and robust system for the long-term maintenance of samples and associated information. So, if your biobank is still facing challenges such as sample processing and storage, chain of custody, traceability and shipping, patient privacy, it is time to switch to a Biobanking Laboratory Information Management System (LIMS).

How can Biobanks benefit from a LIMS?

A LIMS provides several benefits to biobanks such as:

  1. Biobanks receive different types of samples, store these at different storage locations under specific conditions, and ship these samples out of the biobank based upon the client’s request. This process requires a complete tracking of the sample right from receiving it in the biobank until it is shipped out. Managing a large number of samples, their derivative and aliquots along with their storage locations need high quality of precision and efficiency that can be rightly achieved by a biobanking LIMS.
  2. Keep a track of the freeze-thaw cycle of a sample whenever the sample is checked-out of the storage location for any test or analysis.
  3. Raise an alert whenever a sample is about to expire or the sample quantity is about to deplete.
  4. Seamless association of samples with the anonymized subject information and consent forms becomes possible.
  5. Streamlines the management of client’s requests where the client can place sample purchase and sample storage requests using an online portal and can receive an invoice for their requests.
  6. Support for 2D and 3D barcoding ensures easy sample accessioning.
  7. Processes in biobanks involve the transfer of sample from one person to another. LIMS helps to keep a track of the complete chain of custody of the sample.
  8. Optimize the logistic and operational support to researchers and ensures that the samples are made available at the right time and at the right place.
  9. Provides a complete, clear picture by unifying the analytical data with the sample.
  10. There are certain defined standards that a biobank must adhere to such as HIPAA guidelines, 21 CFR Part 11 etc. for data privacy. A LIMS simplifies meeting regulatory compliance by providing a restricted data access, and implementing role-based rights for data access depending on the hierarchy present within the biobank. LIMS also helps to maintain a comprehensive log of all the activities performed within the biobank from start to finish.
  11. Information of the staff available in a biobank can be easily managed within a biobanking LIMS.
  12. If the biobank is involved in performing research study on stored samples, those studies can be easily managed along with the information for the associated samples within a Biobanking LIMS.

Thus, a LIMS ensures increased accuracy and efficiency while minimizing the errors and effort in managing the biobanking processes. Owing to the irreconcilability and adaptability, biobanking LIMS gives increased return on investment (ROI) over time. To achieve these benefits, it is necessary that the collaborating organizations standardize on a single LIMS solution to ensure an integrated research network by secure and easy access to research findings. Though this is a simple statement, it is far from an easy task to accomplish and requires meticulous planning to settle on a LIMS that suffice most of your biobanking requirements.

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Points to Remember while LIMS evaluation and implementation

So, now if you are interested in implementing a LIMS for your biobank or biorepository, the next thought that comes to the mind is from where to begin? How to understand that which is the right LIMS for your biobank? Well, it may be really hard to know where to start. To bridge this gap, we have keyed out the ten most crucial criteria that will help you to evaluate and implement an appropriate LIMS for your biobank:

  1. Know your Biobank Requirements: The first and foremost step of evaluating and implementing a biobanking LIMS is to question yourself, what do you want the LIMS to do for you? This can be addressed by listing and prioritizing your needs and wants. The list will help you maintain focus on your real requirements when evaluating and comparing different LIMS solutions. This will help in narrowing the scope of what you need and finally zero-in on a biobanking LIMS that contain the features that are useful to you.
  2. Getting started with a Demo: The second most important step while searching for a biobanking LIMS is to to get a live online demonstration of various LIMS available for biobanks. Online demos are preferable as these can be recorded, shared and used as a reference for the future. A demo facilitates exploring the capabilities and functionalities of a LIMS in meeting your requirements. Listing the requirements before getting a demo enables to plug in your biobank requirements onto the demonstrated LIMS features.
  3. Strategic and early planning: Planning is a crucial step that should start in an early phase of LIMS evaluation and implementation. The project plan should present tangible business benefits based on defined time-bound activities such as evaluation, selection, testing, data migration, key performance metrics, and any other unforeseen events that may occur during LIMS implementation. An upfront planning involving the key stakeholders helps anticipate the potential problems and thus reduce the time, effort, and money spent on LIMS implementation.
  4. Configurability: Due to the introduction of new processes at frequent intervals, biobank conditions are under a constant flux. Thus, a biobanking LIMS should be highly configurable that takes into account the growing flexibility and scalability of the biobank. Data forms should be flexible to allow easy and quick data entry by biobank users.
  5. Keep data migration in mind: Data is the most strategic and vital asset to any organization and delaying data migration till the end may have a sizeable negative impact on biobank operations.
  6. Consider Complementary modules: In addition to the core product required to meet your needs, you should also look at the complementary modules offered by the biobanking LIMS and whether these modules can be of any help to manage the biobank operations. An example can be how to query, search, request, approve and ship samples using a LIMS for biobanks.
  7. Security: The next crucial criteria is how does the biobanking LIMS under evaluation helps to manage patient privacy and consent? Trustworthiness is a prerequisite for any LIMS and a biobanking LIMS should be equipped with measures for data privacy and security such as data encryption strategies, access to data according to the role-based rights, and data back-ups. Additionally, access to sensitive patient data must be restricted and LIMS should follow the laws and regulations governing privacy and data protection.
  8. Ensure Meticulous Sample Management: Sample management is one of the key activities performed by a biobank. This requires proper accessioning of samples, their aliquots, and derivatives along with their storage location. Further, samples should be annotated with clinical and research information and should be associated with the correct subject. A biobank LIMS should maintain a complete chain of custody of the samples and record audit trail of all the activities performed on the sample.
  9. Budget: A very important aspect that drives the evaluation of any LIMS solution is the budget allocated to the subscription, maintenance, data migration, deployment, etc.
  10. Technical Support: Switching to a LIMS either from spreadsheets or in-house LIMS is a journey that will need consistent support at every step of deployment, data migration, and working with the system. Thus, while evaluating, prioritize the LIMS that provides maintenance and technical support.

Final Consideration

LIMS implementation is one of the most vital decisions for any biobank. Biobanking LIMS helps keep a complete track on the samples from when they are received in the biobank, their storage locations, their complete chain-of-custody until finally, they are associated with an outgoing shipment and shipped out of the biobank. A right biobanking LIMS solution helps protect the data stored within a biobank by implementing several measures like role-based data access, use of digital signatures, etc. Considering these aspects while evaluating and implementing a LIMS will help you navigate the options available in the market and finally zero-in to a LIMS that is most aligned with your biobank requirements.