ISO 20387:2018 and HIPAA Compliant in the Cloud Biobanking LIMS

A Secure, Configurable, Purpose-built LIMS for Biorepositories & Biobanks

A Zero Upfront Cost LIMS to Automate and Streamline Biorepository Workflows

A Comprehensive Guide to Regulatory Compliance for Biobanks

Seamlessly Manage Workflows using CloudLIMS, a SaaS, in the Cloud Biorepository LIMS

Biobanks play a crucial role in the discovery of disease-specific biomarkers, drug discovery, and clinical and translational research. Large biobanks perform several activities such as sample acquisition, collection, sample preparation, storage, testing, analysis, distribution, etc. These activities have an impact on sample quality. Biobanks must maintain the quality of samples so that they are useful for research. Biobanks are also responsible for ensuring patient privacy. Hence, biobanks must safeguard Protected Health Information (PHI), manage patient consent, and ensure that biospecimens collected from patients are used for intended purposes only, for example, cohort studies, etc. Biobanks face numerous challenges, including managing biospecimens, associated metadata, and patient consent, locating stored samples, standardizing operational workflows, ensuring sample integrity, preventing unauthorized access to sensitive data, and following regulatory guidelines such as ISO 20387, HIPAA, EU GDPR, 21 CFR Part 11, audit trail, etc. CloudLIMS helps in securely managing sample and patient data, assigning role-based access to authorized users, following regulatory guidelines, removing data silos, and generating personalized reports. Being hosted in the cloud, CloudLIMS helps in minimizing operational costs for biorepositories and in ensuring data integrity and security.

CloudLIMS - A One-Stop Biobank Software

CloudLIMS is a purpose-built, scalable, SaaS, in the cloud LIMS and grows with your biorepository by supporting your data management, automation, and regulatory requirements. With a cloud solution, the LIMS can be accessed anytime, anywhere, is easy to deploy and enables biorepositories to quickly automate without the need to invest in IT infrastructure or personnel.

CloudLIMS customers have realized benefits in the following ways:
  • Automated workflows to meet regulatory compliance such as ISO 20387:2018 EU GDPR HIPAA 21 CFR Part 11 and ISBER Best Practices.
  • A flexible data model to configure and accommodate specific requirements and avoid costly customization.
  • Customizable modules for managing samples and their genealogy tracking sample locations freezer inventory and managing shipment of samples when working with collaborators.
  • Maintain a Chain of Custody to regulate the internal or external transfer of biospecimens from one custodian to another there by meeting compliance.
  • Assign role-based data access to staff preventing unauthorized access and maintaining PHI (Protected Health Information).

Easily Achieve ISO 20387:2018 Accreditation

Manage all internal and external documents, such as Standard Operating Procedures (SOPs), consent forms, track their revision history, assign documents for review, and control access to confidential documents.

Maintain an automatic Chain of Custody (CoC) to regulate the transfer of biological materials from one custodian to another.

Manage records of all equipment involved in biobanking processes along with their details, such as the manufacturer’s name, model and serial number, schedule instrument maintenance, and send out maintenance or calibration alerts, ensuring upkeep of equipment.

Manage records of past, ongoing, and upcoming training of each staff involved in biobanking activities, maintain a record of staff qualifications, and their competency. Additionally, you can notify staff about upcoming training(s), and generate custom training reports in PDF or MS Excel file format.

Advantages of CloudLIMS
- A Complete Biobank Management Software

Follow Regulatory Compliance

Follow ISO 20387, EU GDPR, HIPAA, 21 CFR Part 11, and ISBER Best Practices.

Manage Specimens

Store annotated sample data, track samples using barcodes, maintain Chain of Custody (CoC), manage all aspects of sample genealogy, and access a complete history of each sample from accessioning to their final disposal.

Manage Sample Storage Locations

Create hierarchical storage units and view storage inventory graphically to manage storage locations of hundreds and thousands of samples, enabling quick and accurate tracking of samples. CloudLIMS can help assign samples to storage locations automatically based on barcodes.

Manage Patients and Other Sample Sources

Seamlessly manage various sample sources such as humans, plants, animals, etc. If you manage a human biobank, CloudLIMS can help you manage patient data and patient consent.

In-house Biobanking

The integrity of clinical samples from how they are collected and processed, to how they are stored plays a crucial role in determining the validity and reproducibility of the generated data. Thus, organizations are constantly put to task to ensure that the integrity of their biospecimens remains uncompromised at all times.

Large hospitals, clinical research organizations, pharmaceutical and biotechnology companies having adequate funding or budget prefer to have an in-house biobank to store samples. As much as this may come at a hefty financial and technical cost, it also comes with several benefits.

Third-party Biobanking

Third-party biobanking enables hospitals, pharmaceutical companies, contract research organizations (CROs), and other research organizations to store their biospecimens securely at third-party facilities. Such facilities offer ample storage for the samples, even though they are not involved in processing or analyzing them. That said, third-party biobanks play a crucial role in facilitating the research process for institutions that may have a dearth of resources to do this on their own. To achieve success with storage with offsite facilities, several factors have to be in place geared towards ensuring sample safety, integrity, validity, and compliance with regulatory requirements.

Commercial Biobanking

Biological samples are recognized as a vital tool in research. Hence, there is an ever-increasing demand for the collection and storage of biosamples. Commercial biobanks are now playing a leading role in collecting and managing biosamples and their associated metadata. They are attempting to offer solutions to biobanking problems such as a lack of public trust, limited resources, and inefficiencies in the non-profit sector.

Commercial biobanks are specially designed to support and provide biological specimens to the contract research organizations (CROs), medical, biopharmaceutical, healthcare sectors to facilitate research and development. They include not only physical biobanks but also virtual biobanks.

Follow Regulatory Compliance

Scientific Advisors

Dr. Jim Vaught

Editor-in-Chief of Biopreservation and Biobanking


Case Study

See how BIRKA BioStorage streamlines biobanking processes

CloudLIMS' Biorepository LIMS Functionality

Study Management

Define and organize a research study, associate it with samples, their source, study in-charge, import study records in a batch, and generate custom study reports.

Package & Shipment Management

Retrieve samples from a storage location and package them. Keep a track of the samples shipped to your clients and collaborators.

Inventory Management

Manage laboratory inventory such as kits, reagents, and other consumables used in biobanking activities, besides associating each inventory with samples, subjects, and custodians.

Services and Billing Management

Manage laboratory services such as sample purchase requests, sample storage requests, and create catalogs with defined pricing for each service offered by your laboratory.

Test Management

Manage tests and test results, analyze trends based on test results, maintain test Chain of Custody (CoC), track Turnaround Time (TAT), validate test results, and generate professional custom test reports. CloudLIMS facilitates interoperability by integration with third-party systems such as LIS, EMR, ERP, HIS, and equipment involved in biobanking activities.

Client Portal

Enable your collaborators to enter samples using the Client Portal. Samples can be entered using spreadsheets or by directly scanning the samples. They can place storage requests for multiple samples, attach notes or instructions for handling and download invoices. The portal offers a self serve facility, thereby enhancing customer service.

What Our Customers Say About Us

Case Studies

The University of Sheffield Automates its Biorepository Data Management Operations using CloudLIMS


Harnessing Cloud Technology for Biobanking Informatics


The State of Cloud-Based Biospecimen and Biobank Data Management Tools


Empowering Biobanks to Comply with the EU GDPR for Personal Data Protection using a Cloud-based LIMS

Happy Customers

Awards & Recognition

CIOReview's 20 Most Promising Pharma and Life Sciences Tech Solution Providers

CloudLIMS joins an elite group of companies as one of the 20 Most Promising Pharma and Life Sciences Tech Solution Providers.

Golden Bridge Award for New Products & Services

CloudLIMS is the Gold winner at the 7th Annual Golden Bridge Awards in the New Products and Services category.

Best in Biz Award for the Most Customer Friendly Company

CloudLIMS wins Bronze at the 5th Annual Best in Biz Award for the Most Customer Friendly Company of the Year.


CloudLIMS joins an elite group of companies as one of the 20 Most Promising Pharma and Life Sciences Tech Solution Providers.


CloudLIMS joins an elite group of companies as one of the 20 Most Promising Pharma and Life Sciences Tech Solution Providers.


CloudLIMS joins an elite group of companies as one of the 20 Most Promising Pharma and Life Sciences Tech Solution Providers.