Astoriom has a high-quality service reputation in the sample stability and biorepository storage industry.
We have built our quality capabilities and expertise over the past 30 years by successfully assisting R&D companies in over 20 industries securing the stability and protection of their valuable sample assets.
We maintain the highest quality assurance processes, meticulous audit trails and superior equipment quality standards to ensure your samples are protected and compliant with all regulatory requirements.
Astoriom’s Quality Principles
Astoriom’s Quality Principles ensure sample storage reliability and consistency.
Our dedicated teams meet ISO 9001:2015 Standards and EU/US GMP Regulations while adhering to Data Integrity Guidelines to meet and satisfy our customer quality requirements across the globe.
Our staff work hard to meet the customer and regulatory expectations set by the industry by following international standards of Quality Principles as well as ICH Q1A Guidelines for Stability Storage Services.
We understand our customers require consistency, traceability and reliability therefore we have an extensive Quality Management System that provides overall management, accuracy and control for the Stability and Storage of your valuable samples.
Global Storage Quality Licenses & Certifications
Astoriom holds numerous global certifications to ensure compliance with regional and international regulations. These credentials validate our commitment to maintaining the highest standards of quality in sample stability and biorepository storage.
Quality Credentials
US
UK
Ireland
ISO 9001
International standard for Quality Management Systems (QMS) ensuring consistent quality across all services. This international standard for Quality Management Systems ensures that Astoriom consistently delivers high-quality services. It helps maintain rigorous operational standards, ensuring the secure and compliant handling of valuable R&D sample assets.
FDA
Compliance with the Food and Drug Administration (FDA) regulations for sample storage. This ensures that Astoriom meets strict regulations for sample storage, protecting our client assets involved in drug development and clinical research in the U.S.
HPRA
Health Products Regulatory Authority compliance for Ireland. Astoriom adheres to European Union standards for the storage of pharmaceutical products, ensuring regulatory compliance for EU-based clients.
cGMP
Compliant with Current Good Manufacturing Practices, ensuring quality in the storage of…compliant for goods and services. Astoriom’s storage and validation processes meet stringent guidelines for quality and safety, offering clients confidence in the handling and preservation of their samples.
ICH Q1A
Stability Testing of New Drug Substances and Products as per ICH Guidelines. Astoriom provides accurate storage conditions to support the shelf-life and integrity of pharmaceutical samples.
ICH Q1B
This guideline covers photostability testing of pharmaceutical products, ensuring that Astoriom can offer controlled environments for testing the effects of light exposure on sensitive samples.
Controlled Drug License
This license allows Astoriom to legally store and handle controlled substances, ensuring compliance with legal and safety standards for clients working with high-security materials.
CLIA
We are CLIA regulated, ensuring that Astoriom meets U.S. federal standards for laboratory testing accuracy, reliability, and timeliness. This provides clients with confidence that their samples are managed in compliance with the highest quality and regulatory standards for clinical research and diagnostics.
CAP
This accreditation demonstrates that Astoriom meets the highest standards in laboratory samples’ quality and safety. It ensures clients that their samples are handled in a facility adhering to rigorous best practices, supporting accurate and reliable results for research and diagnostics.
Our Statement of Quality Policy
Our Statement of Quality Policy ensures we provide a service that is:
High-quality standard
Meets the expectations of our customers and Regulatory bodies and continually improves through the application of the Quality Management System (Quality Manual, QA-POL-2, Astoriom). At Astoriom, we are able to create securely controlled policies and procedures that allow employees to fulfill, maintain and exceed customer expectations and satisfactions. Our QMS is based on Quality Planning, Quality Assurance, Quality Control and Quality Improvement where processes and procedures are audited internally and by our clients on a regular basis to ensure effectiveness and applicability to the standards and regulations we require to meet to provide a consistent high-quality service.
Our Equipment
Our equipment is 21 CFR Part 11 compliant and mapped and monitored with data available upon request. We use a combination of accredited calibrated equipment (UKAS/NIST) to ensure accuracy and reliability of our testing equipment. Customer satisfaction is the backbone of our Quality Management System and therefore, continuous investment in our equipment and talent is constantly ongoing.
The High-Quality Value of Partnering with Astoriom
Quality Management System (QMS)
At Astoriom, our Quality Management System (QMS) is the foundation of our commitment to quality. Built on over 30 years of sample stability and biorepository storage experience, our QMS ensures that every sample in our care is managed with the highest standards for sample storage quality.
Our Quality Management System process is used to set-up, maintain and track the quality of samples across our global network of storage facilities. Sample quality is evidenced through a sample storage audit trail that proves the robustness and compliance of our system to meet exacting regulatory and quality standards. Our customers can be assured their samples are being managed in our facilities with the best processes, security and storage protection.
Audit Trail of Robust Sample Storage Quality & Compliance
Our comprehensive audit trail serves as evidence of the quality and compliance of our samples storage processes. From the moment your samples enter our facility, every step in the storage and handling process is documented, providing a transparent record that can be accessed for audits or regulatory inspections.
We understand the critical importance of outsourcing sample storage to a trusted partner, and we can give you the security and satisfaction your product will be handled, monitored and secured in the appropriate manner.
Equipment Quality & Monitoring Systems
The quality of the equipment used for your sample storage is paramount. At Astoriom, we use only state-of-the-art storage equipment, coupled with advanced monitoring systems to ensure the safety and security of your samples. Our systems are validated and maintained to the highest standards, and all documentation is readily accessible to your auditors upon request.
In the event of any disruption, we have full backup systems in place, including an uninterrupted power supply (UPS) to prevent any risk to your samples. Our IT network is designed to ensure continuity, even during technical failures, with data archiving capabilities for long-term reference.
Why Choose Astoriom for Sample Storage Compliance?
Global Certifications & Compliance
Adherence to ISO, FDA, cGMP, ICH, CAP and MPRA standards, ensuring full regulatory compliance across multiple regions.
Unmatched Expertise
Over 30 years of experience supporting R&D, biopharma, and academic institutions with secure and compliant sample storage.
Comprehensive Audit Trails
Full visibility of sample management through detailed audit documentation.
Advanced Equipment & Backup Systems
Cutting-edge equipment and 24/7 monitoring systems to safeguard your samples against any disruptions.
Proven Track Record
Trusted by over 20 industries globally, including biopharmaceutical, biotechnology, and medical device sectors.