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 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 research 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, 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, Our biobanking LIMS helps in minimizing operational costs for biorepositories and in ensuring data integrity and security.

See how BIRKA BioStorage streamlines biobanking processes

Watch the Digital Transformation Journey of Yashraj Biotechnology Ltd. with CloudLIMS

CloudLIMS - A One-Stop Biobank Software

CloudLIMS is a purpose-built, scalable, SaaS, in the cloud biobanking LIMS and grows with your biorepository by supporting your data management, automation, and regulatory requirements. With a cloud solution, Our LIMS software for biorepositories 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).
  • Manage studies and establish dynamic relationships between attributes across multiple modules and support simple to complex searches across multiple attributes.
  • Support organizational standards with Single Sign-On streamlining user access to multiple applications and ensuring a complete and secure audit trail to meet regulatory requirements.
  • Manage tests and results for clinical and research use and generate reports based on reporting requirements.
  • Manage catalogs for sample purchase, storage, and testing services along with generating invoices.

Easily Achieve ISO 20387:2018 Accreditation with CloudLIMS' Biospecimen Management Software

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.

Seamlessly create aliquots/derivative samples using the same parent sample, along with automatically deducting the parent sample quantity. This allows for effective tracking of sample lineage to evaluate its traceability and association with one or multiple sample types.

Specimen Processing and Fractionation
Specimen Processing and Fractionation

Directly assign storage locations and store samples through the Samples module. The stored samples can be filtered out based on their current status, storage location and association with aliquots/derivative samples.

Specimen Storage and Traceability

Track sample activity for a sample record across multiple modules, ensuring proper chain of custody and sample integrity.

Manage Sample Workflow

Ensure that correct laboratory test results are obtained for biomarkers both within and between laboratories. This allows users to report the use of correct and validated test methods by ensuring reproducibility of test results within and between laboratories.

Biomarker Testing

Tutorials

Learn How to Add, Edit and Store Samples in a Batch

Learn How to Batch Import Samples to the Storage Units

Advantages of CloudLIMS
- A Complete Biobank Management Software

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Follow Regulatory Compliance

Follow ISO 20387, EU GDPR, HIPAA, 21 CFR Part 11, CAP-BAP, National Cancer Institute and ISBER Best Practices.

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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.

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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. our LIMS software for biobanks can help assign samples to storage locations automatically based on barcodes.

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Manage Patients and Other Sample Sources

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

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

Webinar

Scientific Advisors

Dr. Jim Vaught

Editor-in-Chief of Biopreservation and Biobanking

Marianne K. Henderson, M.S., CPC PMP

Division of Cancer Epidemiology and Genetics, NCI, NIH, DHHS

CloudLIMS' Biorepository LIMS Functionality

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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.

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Package & Shipment Management

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

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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.

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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.

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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.

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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.

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Third Party Integrations

CloudLIMS supports the seamless transfer of information from third-party applications, such as EMR, EHR, HIS, ERP, LIS, and more, to CloudLIMS using our REST API. Additionally, CloudLIMS supports the integration of in-house instruments, like Continuous Temperature Monitoring Systems, with CloudLIMS. This integration facilitates the seamless transfer of temperature logs across different storage units configured in CloudLIMS. Moreover, CloudLIMS integrates with sophisticated laboratory instruments and automates the process of fetching test results from instrument files in XLS/CSV format, directly into CloudLIMS.

What Our Customers Say About Us

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Case Studies

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

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Presentations

Harnessing Cloud Technology for Biobanking Informatics

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Publications

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

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Posters

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

Happy Customers

Our Awards and Recognition

G2 Awards CloudLIMS as High Performer Small Business in Fall 2023
G2 Recognizes CloudLIMS as Easiest To Do Business With Small Business in Summer 2023
G2 Recognizes CloudLIMS as Easiest To Do Business With Small Business in Winter 2023
CloudLIMS has won the SoftwareSuggest Customers Choice Winter 2022 Award
CloudLIMS Capterra Reviews