The 6 Pillars of Biorepository Compliance
- Chanda London
- 3 days ago
- 2 min read
Biorepositories are the backbone of modern research, but compliance is what ensures their credibility, sustainability, and scientific value. Accreditation bodies such as CAP, ISBER, and guiding frameworks like the NCI Best Practices provide standards—but without a clear framework, labs can feel overwhelmed by requirements.
To simplify the path, I’ve distilled biorepository compliance into six core pillars. These pillars provide structure, protect research integrity, and position labs for long-term success.
1. Governance & Resource Management
Strong leadership, clear organizational structures, and documented policies form the foundation of compliance. Governance defines accountability, ensures oversight, and aligns operations with institutional goals.
2. Biospecimen Lifecycle Integrity
From collection to long-term storage and distribution, biospecimens must be handled with precision. Controlling pre-analytic variables, storage conditions, and shipping processes safeguards scientific validity.
3. Quality Management & SOP Systems
A robust Quality Management System (QMS) supported by validated Standard Operating Procedures (SOPs) ensures consistency and audit readiness. This is the DNA of a compliant biorepository.
4. Biosafety & Risk Management
Protecting personnel, facilities, and specimens requires strict adherence to biosafety standards, OSHA/CDC guidelines, and risk preparedness planning. Safety is compliance in action.
5. Clinical Data & Informatics
Specimens without data lack value. High-quality annotation, secure informatics systems, and interoperability standards ensure specimens remain research-ready and regulatory compliant.
6. Ethics, Legal, & Policy Alignment
Ethical stewardship underpins trust in research. Informed consent, privacy, confidentiality, and fair access policies ensure compliance beyond the laboratory—protecting both institutions and participants.
Continue the Conversation
Watch the full video on the 6 Pillars of Biorepository Compliance on The Compliant Lab YouTube channel
Read the LinkedIn newsletter for a condensed compliance perspective
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