Free eBook: A Comprehensive Guide to Regulatory Compliance for Biobanks
Biobanks are responsible for maintaining high-quality, fit-for-purpose samples for use in research. Regulations act as the guardrails as biobanks shoulder the responsibilities of managing samples and metadata, preserving sample and data integrity, and safeguarding donor information and consent. It is critical that biobanks comply with the different national and international regulations to assure sample quality and drive transnational research, failing which they may be subject to hefty penalties and even restitution. This eBook is the ultimate guide for biobanks to navigate regulatory complexities. It also touches upon how a LIMS can help biobanks meet compliance goals seamlessly.
- 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?