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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 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, CloudLIMS helps in minimizing operational costs for biorepositories and in ensuring data integrity and security.
Case Study
See how BIRKA BioStorage streamlines biobanking processes
Mr. Hussein Ismail
CEO and Vice President
BIRKA BioStorage AB
Sweden
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 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.
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.
Track sample activity for a sample record across multiple modules, ensuring proper chain of custody and sample integrity.
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.
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
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
Dr. Jim Vaught
Editor-in-Chief of Biopreservation and Biobanking
Dr. Jim Vaught spent 14 years at the U.S. National Cancer Institute (NCI), most recently as the Chief of the Biorepositories and Biospecimen Research Branch (BBRB) in the Cancer Diagnosis Program. He has been working in the field of biorepository and biospecimen science for over 20 years. In 1999, he was one of the founding members of the International Society for Biological & Environmental Repositories (ISBER). He serves on a number of biobank advisory groups including the Telethon-Italy Genetic Biobank Network; the Biobanques Network (France) Scientific Board; and the Provia Labs (Boston) Advisory Board. He is a member of the Board of Directors of the National Disease Research Interchange. He is Senior Biobank Advisor to the Shanghai Clinical Research Center. In addition to ISBER, Dr. Vaught is a member of the American Association for Cancer Research (AACR), the American Society for Pharmacology and Experimental Therapeutics, the European Society for Biopreservation & Biobanking, the American Association of Blood Banks, and the American Association for Clinical Chemistry. He is the author of over 70 peer-reviewed articles and book chapters. From 2006 to 2012 he was Senior Editor for Biospecimens and Biorepositories for the AACR journal Cancer Epidemiology, Biomarkers and Prevention. In 2012 he became Editor-in-Chief of Biopreservation and Biobanking, the official journal of ISBER. He is currently a Senior Research Fellow at the International Prevention Research Institute (Lyon), and a consultant for a number of international biobanking activities. Dr. Vaught is the President of ISBER for 2015-2016.
Marianne K. Henderson, M.S., CPC PMP
Marianne K. Henderson, M.S., CPC PMP
Division of Cancer Epidemiology and Genetics, NCI, NIH, DHHS
Ms. Henderson is the Senior Advisor for Division Resources and Biobanking in the Division of Cancer Epidemiology and Genetics of the U.S. National Cancer Institute, NIH. She supports large program and contract management, and infrastructure planning for molecular epidemiology. She is active in the International Society for Biological and Environmental Repositories (ISBER) (President 2011-12 and Chair, OAC 2012-2019, Science Policy, and Education and Training CoP). She has received the ISBER Founders Award and the ISBER Distinguish Leadership and Service Award for her dedication to biobanking globally. She is E&T Co-Chair of the WHO/IARC-led LMIC Biobank and Cohort Building Network (BCNet); She sits on the editorial board for Biopreservation and Biobanking. Ms. Henderson is actively involved in large-scale biospecimen process improvements in operations, technology transfer, sustainability and repository automation.
CloudLIMS' Biorepository LIMS Functionality
What Our Customers Say About Us
"CloudLIMS is accessible anywhere, any time, as long as there is internet connection which allows more flexibility to use amongst our team. It is also configurable on multiple levels so no matter what kind of operations the end-user is running, CloudLIMS is more than likely to achieve your operational needs. Technical support is also supportive, ensuring the customer feels comfortable and competent using the application by consistent communication and regular meetings with fast response times too. There are a couple refinements that can be made, such as the arrangement of columns for some windows, the data types, and additional statuses (sample collected, sample picked up, sample received, etc) to track samples through its chain of custody/workflow.
It is also a solution to improve our workflow to reduce time manually updating databases, handwriting forms, and manually assigning codes to subjects and samples. With the implementation of CloudLIMS, we are able to have a much more seamless workflow with transparency throughout our entire facility on the chain of custody of samples, our inventory, the progress of our accruals to keep track of metrics, and much more."
"Our biorepository is mainly comprised of biospecimens from cancer patients, including blood, tumor, adjacent normal tissue, adipose tissue, and urine. Our partner hospitals in India collect these samples, which are then processed and stored at our facility. What we like best about CloudLIMS is the product functionality and perseverance of the CloudLIMS team in addressing our challenging needs. The feature that stands out for us is the ability to track the complete genealogy of samples and manage patient data, including patients' consent. With this feature, we can trace the history of each sample easily, including the patient from whom it was collected, the condition of the patient at the time of collection, etc. The product also enables us to meet ISO 20387 compliance requirements with ease. The team's support during our evaluation process was excellent, and they answered all our questions satisfactorily. We conducted thorough testing before purchasing the product. Our entire team, including C-level executives, participated in the evaluation process, and we were impressed with the product's full capabilities."
"We have experienced CloudLIMS’ biobanking LIMS and are thoroughly impressed with its capabilities, ease of use, top-of-the-line security features, and affordability. The LIMS, packed with a wide range of complimentary services, has proven to be a flexible and scalable solution for managing our biorepository. What I find most remarkable about CloudLIMS is its ability to exactly mirror our freezers and everything within it. The product pricing is extremely competitive, especially given the level of functionality and support that they provide. Recently, we were in search of a LIMS for a multidisciplinary project we are embarking on, and we decided to use CloudLIMS once again, given that it has all the necessary features to align with our workflows and fulfill our data management, workflow automation, regulatory and quality management requirements. I highly recommend CloudLIMS to anyone looking for a secure, reliable, user-friendly solution for managing their biobank."
“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.”
Happy Customers
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