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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:
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
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
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Case Study
See how BIRKA BioStorage streamlines biobanking processes
CloudLIMS' Biorepository LIMS Functionality
What Our Customers Say About Us
“We recently had the pleasure of meeting the CloudLIMS team at the IBS 2023 Annual Conference & Exhibition in New Delhi, India, and our experience with them was exceptional. Selecting a vendor for a Laboratory Information Management System (LIMS) can be daunting, but CloudLIMS stood out for us due to their expertise in the industry and prior experience in streamlining the operations of another group we knew. The fact that CloudLIMS is a purpose-built LIMS for both biobanks and clinical research labs, which are the two types of facilities we have across India, made our decision easy. During the demo, we were greatly impressed by the functionality and intuitive interface of CloudLIMS.
We will be using CloudLIMS for our biobanking facility in Kolkata and our outstation sites as well. We plan to expand to our clinical research labs in the future. Their expertise, reliability, and commitment to customer satisfaction make them a top choice for any biobank or clinical research facility looking for a robust LIMS system. I would highly recommend CloudLIMS.”
“We at Garner Bio take pride in providing ethically sourced and ethnically diverse high-quality samples on demand. We were looking for a LIMS for our commercial biobank and zeroed in on CloudLIMS. It has all the functionality to meet our workflows, besides data and quality management needs. We were greatly impressed by the product demo, the pre-sales support that we received, and the hassle-free order fulfillment process. Thank you, CloudLIMS, for making such a wonderful product for biobanking!”
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.