Dual ISO framework establishes one of the industry’s most comprehensive quality systems for regulated material management
RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–GXP-Storage, a life sciences leader in compliant, visible and scalable material management, announced today that it has earned ISO 20387:2018 certification for biobanking and biomaterial resources. The certification was issued by the American Association for Laboratory Accreditation (A2LA) and validates GXP-Storage’s biobanking excellence across its purpose-built facilities in Research Triangle Park, North Carolina, the United Kingdom’s Golden Triangle and its proprietary GXP-Guardian® digital platform.
This achievement, combined with GXP-Storage’s ISO 9001:2015 certification, establishes one of the industry’s most comprehensive dual ISO quality frameworks for regulated material management.
“Our ISO 9001 certification validated our operational excellence. Today, ISO 20387 extends that foundation into specialized biobanking,” said Jeff Johnson, Founder and CEO of GXP-Storage. “Unlike diversified providers who treat biobanking as one of many services, we are 100 percent focused on regulated storage. Every facility, process and SOP is purpose-built to withstand regulatory scrutiny and to ensure that our customers’ specimens, samples and tissues maintain complete lifecycle integrity.”
The ISO 20387 certification demonstrates GXP-Storage’s commitment to protecting irreplaceable biological materials under the most stringent global standards, from cell and gene therapies to precision medicine and rare disease research. Together, ISO 9001 and ISO 20387 confirm that GXP-Storage’s operations meet the highest levels of quality, traceability and reliability across every stage of material management. Customers of GXP-Storage benefit through:
- Complete custody visibility: zero blind spots across every phase of the sample lifecycle
- Accelerated inspection readiness: audit-proven systems that make inspections routine, not stressful
- Validated environments: confidence that every sample is stored, tracked and monitored within compliant, continuously controlled conditions
The certification also underscores the strength of the company’s GXP-Guardian digital platform, which unifies purpose-built infrastructure with predictive analytics and immutable chain-of-custody records. This digital-first, AI-ready biobanking system transforms compliant storage from an operational burden into a strategic advantage by delivering:
- Predictive intelligence that identifies and mitigates risks before they occur
- Immutable audit trails for end-to-end regulatory confidence
- Seamless scalability across global research, clinical and manufacturing programs
“Together, these capabilities give life sciences organizations the confidence, continuity and control required for today’s most advanced therapies,” said Johnson. “We’re proving that compliant storage isn’t just a requirement; it’s a true competitive advantage.”
About GXP-Storage
GXP-Storage is the trusted partner for regulated material management in life sciences. Combining purpose-built facilities with the validated GXP-Guardian® digital platform, the company delivers total custody, real-time visibility and audit-proven compliance across every temperature—from ambient to cryogenic. Trusted by global pharma, biotech, CDMO and healthcare organizations, GXP-Storage transforms storage from a compliance risk into a strategic advantage. Learn more at www.gxp-storage.com.
Contacts
For GXP-Storage
Mandy Wilkins
Propel Marketing Group
[email protected]
