Certification Success Tips

Introduction As biotech and life sciences labs increasingly shift to cloud-based systems for managing research, inventory, and compliance, data security becomes paramount. ISO-aligned protocols ensure that this digital transformation doesn’t compromise data integrity, confidentiality, or regulatory obligations. Why Cloud-Based Lab Management Needs Certification While cloud-based Laboratory Information Management Systems (LIMS) offer flexibility, scalability, and collaboration, they also pose risks: Cyberattacks on sensitive research and patient data Data loss or unauthorized access Regulatory non-compliance in handling genetic or clinical data ISO standards help labs build a strong, secure digital foundation. Applicable ISO Standards for Cloud Lab Systems ISO/IEC 27001: Core for establishing an Information Security Management System (ISMS). ISO 27017: Specific guidelines for cloud service security. ISO 27018: Protects personally identifiable information (PII) in cloud environments. ...

Introduction In clinical research, biobanks play a pivotal role in storing biological specimens for long-term study. As research advances, the need for traceable, secure, and standardized sample management becomes critical. ISO certification ensures that every sample—from collection to disposal—can be reliably tracked and ethically managed. Why Traceability Matters in Biobanks Each biological sample in a biobank is linked to patient data, study timelines, and regulatory obligations . Mislabeling, loss, or unauthorized access to samples can derail research or cause legal challenges. Traceability ensures data integrity , supports reproducibility, and builds public trust. Relevant ISO Standards for Sample Traceability ISO 20387: Specifically designed for biobanking, this standard ensures consistent handling, documentation, and quality control of biological materials. ISO 9001: Helps establish a quality management system that oversees traceability protocols. ISO/IEC 27001: Strengthens...