Wilmington, Delaware – January 31, 2023, CloudLIMS, a leading provider of laboratory informatics, today published a free, open-access eBook titled “A Comprehensive Guide to Regulatory Compliance for Biobanks”.
Biobanks are responsible for maintaining high-quality, fit-for-purpose samples for use in research. They perform several functions including sample acquisition, preparation, storage, analysis, testing, and distribution. In addition to preserving the integrity of biospecimens throughout their lifecycle, biobanks are also expected to safeguard the Protected Health Information (PHI) of donors, manage donor consent, and ensure collected biospecimens are only used for the intended purpose. Since they handle sensitive biological materials and their associated data, national and international standards and regulatory compliance have been set to guide and govern them.
This eBook provides in-depth guidance on regulatory compliance for biobanks, be it any size. Regulations covered in the eBook include HIPAA, ISO 20387, 21 CFR Part 11, EU GDPR, ISBER & NCI Best Practices. It also delineates laws pertaining to the use of biosamples, data protection, and clinical trials in the EU, Finland, the UK, France, Germany, China, Brazil, and India. Finally, the eBook sheds light on how a LIMS can help biobanks meet compliance goals and follow quality standards with ease.
What is included in the eBook:
- The importance of regulatory compliance for biobanks
- Types of biobanks
- Regulatory requirements for biobanks such as GDPR, HIPAA, 21 CFR Part 11, ISO 20387:2018, ISBER & NCI Best Practices
- The regulatory framework of biobanks worldwide
- How can a LIMS help biobanks meet compliance needs?
- How to select the right LIMS for your biobank?
- Why cloud-based LIMS for biobanks?
- How can digital solutions transform biobanking?
“This eBook provides a 360-degree overview of biobanking regulatory requirements,” said Arun Apte, CEO at CloudLIMS. “The guide doesn’t offer simple generalizations but carefully and exhaustively delineates regulations governing the biobanking industry and what it takes to comply with them. Anyone can download this online book for free,” he continued.
CloudLIMS.com offers a secure, in-the-cloud, SaaS LIMS with zero upfront cost purpose-built for biobanks. CloudLIMS offers a wide range of complimentary services, including technical support and training, automatic product upgrades, legacy data migration, product configuration, automatic data back-ups twice a day, and secure data access. CloudLIMS helps biobanks maintain user access for PHI control, manage samples and metadata, automate and streamline workflows, meet compliance and follow best practices such as ISO 20387:2018, EU GDPR, HIPAA, 21 CFR Part 11, and ISBER Best Practices. CloudLIMS.com is a SOC 2 compliant and ISO 9001:2015 certified informatics company.
Mrinal Kanti Chatterjee