Biobanking LIMS Software to Manage Biobanking Operations

A Free, Secure, Configurable, and Scalable Biobanking LIMS for In-house and Commerical Biobanks

Biobanks or Biorepositories are, by definition, a bank or collection of biological samples. These include both physical samples like tissues, blood, cell lines, organisms, etc., as well as biological and medical data corresponding to these samples. Most biobanks store these specimens on a large scale to provide them as a service for both internal and external researchers. They are an important resource for biomedical research and the subsequent development of drugs for treatment. The quality of these specimens and the accuracy of the associated metadata often dictate the route the research takes and the possible outcomes. 

Biobanks shoulder the responsibility of safeguarding the confidentiality of sample donors. As part of this commitment, biobanks are tasked with securing Protected Health Information (PHI), overseeing donor consent procedures, and regularly monitoring biobank activities to safeguard sample and data integrity at all times.

Moreover, biobanks must adhere to regulatory standards to maintain their operational legitimacy and assure high-quality samples for research. These include international benchmarks such as ISO 20387, which ensures the quality and traceability of specimens; the Health Insurance Portability and Accountability Act (HIPAA) in the United States, which mandates strict data privacy protections; the European Union’s General Data Protection Regulation (EU GDPR), which sets stringent personal data protection requirements, and 21 CFR Part 11, a U.S. Food and Drug Administration (FDA) guideline for electronic records and signatures. Compliance with these regulations is vital for upholding the ethical and legal standards integral to biobanking practices.

A high-quality biobank not only accommodates proper storage of these biological specimens to maintain sample integrity and quality, but also offers updated and well-designed documentation of the supporting metadata. This data also includes de-identified and protected subject information and a carefully maintained chain of custody of the samples. It is important for biobanks to have a dedicated automated system for managing these records, thus eliminating the possibility of human errors.

FreeLIMS‘ biospecimen management LIMS software helps you manage a wide range of samples stored in biobanks from receipt through storage and subsequent retrieval while meeting the specific needs of the biorepository. It is pre-configured to meet the diverse requirements of in-house and 3rd-party biobanks, with user-controlled configuration available to enable each biobank to set up its signature workflow. Besides, it also facilitates you to meet regulatory compliance such as HIPAA, 21 CFR Part 11, ISO 20387, ISBER Best Practices, and EU GDPR.

Biorepository Management Software Key Benefits

  • Automate biobanking workflows
  • Organize & efficiently manage data
  • Generate custom reports, including PHI audit reports
  • Foster compliance with regulatory guidelines and biobanking best practices
  • Collaborate with all stakeholders in real-time

Biospecimen Management LIMS Software Features

Biobanking LIMS or biorepository LIMS, also known as biobanking sample management software, has several features, including:

  • Sample management throughout the entire sample life cycle
  • Storage tracking to organize samples in a customizable and hierarchical storage pattern. It also provides a virtual visualization of your storage inventory, enabling you to exactly locate samples in freezer units
  • Genealogy to maintain sample lineage
  • Chain of Custody to ensure staff accountability as samples traverse through the sample lifecycle
  • Subject/Donor management to maintain sample donor information, including details about age, demographics, medical conditions, etc
  • Data confidentiality and compliance maintained via defined user roles to restrict unauthorized access and group-based access permissions for sample locations
  • Audit trail records staff actions along with the staff name and the corresponding date and time of execution.
  • Donor consent management for all biological samples
  • Manage laboratory inventory such as reagents, kits, and other consumables and associate inventory with samples, subjects, and custodians
  • Organize a research study, associate it with samples, batch-import study records, and create custom study reports
  • Retrieve samples from a storage location, prepare them for shipment, and maintain a record of samples sent to customers and partners

Our Secure Biospecimen Management LIMS Helps You Meet ISO 20387 Guidelines and ISBER Best Practices

  • Anonymize Sensitive PHI and Limit PHI Access to Authorized Staff

Access controls within the LIMS restrict PHI access to authorized personnel based on their roles and responsibilities. This ensures that PHI remains confidential, protecting patient privacy and reducing the risk of unauthorized data breaches, aligning with ISO 20387’s emphasis on donor data security and confidentiality.

  • Manage Personnel Competence and Training

FreeLIMS’ laboratory software for biobanking enables comprehensive monitoring of lab personnel, including their competencies, certifications, and training advancements. It generates skill reports for staff and issues notifications for upcoming training, ensuring tasks are only delegated to personnel with up-to-date or relevant training, preventing assignments to inadequately trained or incompetent staff.

  • Ensure Proper Functioning of Lab Equipment

You can establish calibration timetables for equipment and maintain meticulous records that monitor calibration, maintenance, and pre-use functional checks. Furthermore, FreeLIMS’ biorepository software enables you to schedule preventive maintenance in strict accordance with the manufacturer’s guidelines and flags equipment that is not fit for purpose.

  • Maintain a Chain of Custody (CoC) Through the Sample Lifecycle

FreeLIMS’ LIMS software for biobanks and biorepositories helps you maintain a CoC of all samples/aliquots/derivatives throughout their lifecycle to regulate their transfer from one custodian to another. The transport of samples can be internal (i.e., within a biobank) or external (i.e., shipment of samples outside a biobank).

  • Manage Documents

You can manage all internal and external documents, such as standard operating procedures (SOPs), consent forms, and quality management manuals. FreeLIMS’ biorepository LIMS tracks the revision history of each document so that staff members access only the latest version of documents. It also provides role-based document access rights to staff, providing controlled audit-recorded access to confidential documents.

  • Process Samples Efficiently

Effortlessly generate aliquots or derivatives from a sample while automatically deducting the parent sample’s volume. This ensures precise sample lineage tracking, enabling biobankers to automatically maintain a parent-child relationship of all samples and restock depleting samples if they are in demand.

  • Filter and Find Samples of Interest

You can then filter stored samples based on their present status, storage location, and their association with aliquots or derivative samples.