In life sciences, every sample tells a story; and every story depends on trust.
When your research, therapy or product development pipeline relies on irreplaceable biological materials, confidence in how those materials are stored, monitored and retrieved isn’t optional. It’s everything.
That’s why GXP-Storage’s achievement of ISO 20387:2018 certification marks a defining milestone not only for the company, but for the regulated biobanking industry as a whole.
Combined with our ISO 9001:2015 certification earned earlier this year, the dual framework establishes one of the industry’s most comprehensive and fully validated quality systems for regulated material management.
What ISO 20387 Really Means
While ISO 9001 provides a foundation for operational excellence through a Quality Management System (QMS), ISO 20387 takes that discipline deeper into the technical and scientific competencies required for biobanking.
ISO 20387 is the international standard for biobanking quality and competence. It defines how biological materials and associated data must be collected, processed, stored and distributed to maintain their integrity, traceability, and reproducibility.
In practical terms, ISO 20387 answers a simple but critical question:
Can your biobank prove, with complete confidence, that every specimen has remained fit for its intended purpose?
At GXP-Storage, the answer is a definitive yes. The certification validates that our facilities, personnel and processes meet the highest global benchmarks for:
• Technical competence — expert handling, documentation and maintenance of biological materials
• Traceability — from collection through release, every step is auditable and digitally recorded
• Quality assurance — continuous monitoring and calibration to maintain storage specifications
• Ethical and procedural integrity — operations aligned with international biobanking and research standards
For organizations navigating complex regulatory expectations, that assurance translates into real-world value: fewer compliance risks, smoother inspections and full confidence that every material will withstand regulatory review.
A Dual ISO Framework Built for Regulated Science
Our dual ISO certification, ISO 9001 for quality management and ISO 20387 for biobanking competence, creates a complete system of operational and technical assurance.Where ISO 9001 validates how we manage quality, ISO 20387 validates what that quality protects: the integrity of biological materials that power modern research and medicine.
Together, these certifications confirm that GXP-Storage operates with precision and accountability across every dimension of custody. Customers’ gain:
• Complete custody visibility – zero blind spots across the entire sample lifecycle
• Accelerated inspection readiness – audit-proven systems that make inspections routine, not stressful
• Validated environments – confidence that every specimen is stored and monitored under continuously controlled, compliant conditions
“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 clients’ specimens, samples, and tissues maintain complete lifecycle integrity.”
This exclusive focus, regulated storage, and nothing else, allows GXP-Storage to deliver what diversified service providers can’t: complete custody and compliance that scales seamlessly from early research to global commercialization.
Digital Validation: The Other Half of Compliance
Certifications confirm competence. But in today’s digital-first world, compliance also depends on the systems that capture, store and secure data.
That’s why GXP Storage’s validated GXP-Guardian® platform is so integral to the ISO 20387 framework. It ensures that every electronic record (temperature readings, custody handoffs and system events) is managed under the same regulatory rigor as the physical specimens themselves.
Our platform is validated under both 21 CFR Part 11 (the FDA standard for electronic records and signatures) and GAMP 5 (the global benchmark for computerized system validation). Together, these frameworks ensure:
• Immutable data integrity: no record can be altered or deleted without trace.
• Secure electronic signatures: legally equivalent to handwritten approvals.
• Comprehensive audit trails: full visibility of every user action and system event.
• Predictive monitoring: AI-ready analytics that flag potential deviations before they become issues.
This means that ISO certification doesn’t stop at our loading docks; it extends through every layer of digital oversight. Every record that supports our ISO compliance is validated, protected and inspection-ready.
Why ISO 20387 Changes the Biobanking Landscape
Historically, biobanking compliance has varied widely. Some providers built quality systems for logistics, not regulated custody. Others relied on paper logs or legacy databases ill-suited for audit scrutiny.
ISO 20387 is raising the bar, and GXP-Storage is helping redefine what excellence looks like. This certification doesn’t just prove that we meet today’s expectations; it shows we’ve engineered our systems for tomorrow’s science.
The benefits extend beyond compliance:
• Operational efficiency: fewer errors, faster retrievals and simplified oversight
• Cost optimization: reduced redundancy and vendor consolidation
• Global Regulatory confidence: built-in readiness for FDA, EMA and MHRA inspections
• Scientific continuity: assured sample quality that protects research validity and patient outcomes
For our customers—leaders in cell and gene therapy, precision medicine, vaccine development and rare disease research—this assurance translates into speed, reliability and peace of mind, especially if your research and manufacturing facilities have a global footprint.
Beyond Compliance: Built for Confidence
Earning ISO 20387 is more than a milestone; it’s part of our continuous mission to set new standards for regulated material management.
It reinforces what GXP-Storage was built to deliver: total custody, total visibility and total confidence.
For organizations managing materials that can’t be replaced, ISO 20387 certification ensures they’re protected by systems and people who understand what’s at stake.
At GXP-Storage, compliance isn’t a department. It’s our DNA.
Next in this Series
Part 2 – “Engineering the Future of Biobanking: How GXP-Guardian® Transforms Compliance into Intelligence.”
We’ll explore how our digital-first, AI-ready architecture turns compliance from oversight into the foresight powering predictive monitoring and proactive quality assurance.
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.