At SciSafe, we view certifications like Good Manufacturing Process (GMP) not just as tasks to complete, but as necessities for building customer trust. In the biopharmaceutical industry, each vial, batch, or sample can represent years of hard work and millions of dollars invested. That’s why maintaining industry-leading biostorage service quality is integral to SciSafe; it’s ensured in every one of our purpose-built Current Good Manufacturing Process (cGMP) facilities, biorepositories, and cold storage warehouses.
Our clients entrust their reputation to us, and we take that responsibility extremely seriously. Quality is our highest priority; it is built into everything we do for every client. Every SciSafe team member is committed to upholding the highest standards and delivering exceptional performance.
As a trusted cold chain logistics and GMP warehouse partner with over 15 years of experience, we understand the importance of what’s at stake.
GMP: The SciSafe Standard
Patients and practitioners rely on adherence to GMP standards to ensure the quality of pharmacy products. SciSafe operates with a deep understanding of GMP requirements—not only what the guidelines say but also what they mean in practice.
Every SciSafe facility is built from the ground up with GMP principles in mind, including:
Validated infrastructure: From ultra-low temperature freezers to vapor-phase LN2 tanks, our storage systems are qualified and monitored 24/7.
SOP-driven operations: Every procedure is documented, trained, and audited, ensuring consistency across teams, shifts, and sites. SciSafe has developed over 86 Standard Operating Procedures (SOPs) that govern all business functions. A robust Quality Manual and Corrective and Preventive Action (CAPA) system, modeled after the FDA-required systems (21 CFR parts 210 and 211) for pharmaceutical manufacturers, makes SciSafe a valued partner at every stage of drug development and distribution.
Qualified personnel: Our staff are experienced and continuously trained in GMP best practices.
End-to-end traceability: We maintain complete audit trails and chain of custody records from receipt to release.
This level of rigor isn’t just about compliance; it’s about delivering confidence to our clients daily. Download our Good Practices in Life Sciences White Paper to learn more about GMP, Good Clinical Practices (GCP), and Good Laboratory Practices (GLP).
CAP-BAP Accreditation: A Must for Cold Chain Biostorage Services
Accuracy, reliability, and integrity are crucial when storing clinical trial samples, especially biospecimens such as blood, plasma, serum, and DNA. That’s why SciSafe maintains College of American Pathologists Biorepository Accreditation Program (CAP-BAP) compliance—for our clients, this isn’t just about storage. It’s about safeguarding science.
CAP-BAP accreditation signals that SciSafe’s systems, staff, and standards have been vetted at the highest level. This is another reason why customers trust SciSafe for their biostorage service needs.
Why Third-Party Audits Matter (and Why We Welcome Them)
When a third-party auditor walks through our doors, we don’t circle the wagons—we roll out the red carpet. We build our systems and culture to ensure we are ‘always audit-ready’, whether for a client quality assurance visit or a formal inspection by a certification body. SciSafe has completed 7 FDA inspections without any findings. We treat every audit as an opportunity to demonstrate our commitment to excellence and validate our customers’ trust.
Third-party audits help ensure:
- Adherence to global regulatory standards (GMP, GDP, ISO)
- Quality management system effectiveness
- Effective documentation practices and workflows
Being ‘always audit-ready’ means there are no surprises. When clients partner with SciSafe, they entrust their reputation to us, a responsibility we take seriously.
The Risks of Non-Certified Storage
With biostorage services, a slight misstep can lead to significant setbacks. One temperature excursion, undocumented deviation, or failed audit can compromise your product, project timeline, budget, and regulatory approval.
At SciSafe, we’ve built our model to avoid these risks and help our clients sleep better at night, knowing that proven systems protect their assets.
What Sets SciSafe Apart?
Many companies claim to be GMP-compliant for marketing purposes. At SciSafe, we walk the walk. Our facilities are specifically designed to support the storage of biologics, vaccines, diagnostics, clinical trial samples, and other high-value regulated materials.
Some other ways SciSafe is different:
- Scalable solutions: Whether you’re storing five vials or 50,000, we tailor our service to meet your specific needs.
- Global solutions: With locations in the U.S. and Europe, we maintain harmonized SOPs, systems, and training across all sites.
- Client-driven solutions: We work closely with your Quality Assurance (QA) and operations teams to meet your specific compliance and documentation requirements.
- Built-in audit support: Do you need records for an FDA inspection? Are you preparing for MHRA or EMA oversight? Our team helps streamline your reporting needs.
- Trusted Experience and Proven Results: We have the experience and know-how to best serve our customers.
SciSafe’s biostorage service clients tell us repeatedly that our certifications make their lives easier and their programs more resilient.
Trustworthy Biostorage Services
Trust is earned—every day, every sample stored, every shipment made. In a field where lives are on the line and innovation is the norm, storage is no longer a back-office function. It’s a critical piece of your clinical and commercial operations. And it demands a dynamic partner who meets your quality expectations.
At SciSafe, trust is built one interaction at a time: one SOP followed, one alarm responded to, and one audit passed with flying colors. That’s the foundation on which we’ve built our business—contact us to discover why some of the world’s most innovative biopharma companies choose our biostorage service to safeguard their most critical materials.