Disaster Recovery
Stability storage disaster recovery to keep your samples safe
At Q1 Scientific, we understand that unexpected events can disrupt your stability studies, resulting in critical losses. That’s why we offer a robust disaster recovery plan tailored specifically for pharmaceutical and medical device companies. Our ICH and cGMP compliant storage solutions provide peace of mind, ensuring continuity for your valuable samples.
Disaster recovery capability – what set’s us apart?
At Q1 Scientific, we are dedicated to providing unparalleled service and reliability. Here’s what sets us apart:
- Fast response: Transfer your stability samples within 24 hours of a breakdown.
- Custom conditions: From -80°C to +50°C with full humidity control, we’ve got you covered.
- 50,000 sq ft capacity: Ample space to safeguard your samples.
- Expert team: Ready to answer your questions and provide seamless transitions.
Don’t wait for a crisis. Contact us to reserve back-up space and protect your research.
The impact of stability chamber failures
When a stability storage chamber fails, it can have significant repercussions on your operations:
- Loss of data and months of work: A chamber breakdown risks losing valuable data accumulated over months, delaying product development and hindering getting drugs or medical devices to market.
- Disrupted stability studies: Ongoing stability studies are affected, impacting expiration dating accuracy and potentially leading to regulatory compliance issues.
- Risk to product quality: Malfunctioning chambers compromise sample integrity, degrade active ingredients, and affect overall product quality.
- Financial impact: Beyond repairs, costs include lost productivity, retesting, and potential product launch delays.
- Regulatory concerns: Chamber failure may raise concerns about sample viability in regulatory submissions.
Risk management made easy
We understand that your stability studies are critical. Whether you’re a lab manager, quality analyst, or pharmaceutical professional, interruptions can be costly. That’s why we offer tailored solutions to keep your samples secure, even in emergencies.
Primary and contingency storage
- Store additional samples: Need extra space? Reserve it with us. We’re your safety buffer, ready to step in when you need us most.
- Environmental flexibility: Our stability spaces cover a range of conditions. From -80°C to +50°C with a full range of humidity control, we’ve got you covered.
Disaster recovery capability
- Swift transfers: If your in-house chamber falters, we’re on standby. Transfer all stability samples to Q1 Scientific within hours.
- Technical agreements: We work closely with clients, ensuring the necessary documentation is in place for seamless disaster recovery.
Safeguard your stability samples
Don’t wait for a crisis. Reserve your back-up space today and protect your research against the unthinkable. Experience the relief of preparedness with Q1 Scientific and feel:
- Relieved: Knowing that your critical stability samples are protected even in emergencies.
- Confident: Through having a well-structured plan in place with Q1 Scientific as your safety net, ready to swiftly respond and transfer samples when needed.
- Empowered: With a disaster recovery procedure to proactively manage risks. Handle unforeseen events without significant interruptions to your stability studies.
- Assured: In Q1 Scientific’s capabilities with technical agreements and quality audits to ensure that everything is documented and transparent.
Reserving your back-up stability storage space with Q1 Scientific is simple
Follow these steps:
- Contact us: Fill out the contact form or call our expert team. They’ll guide you through the process and answer any questions you may have.
- Customise your space: Let us know your specific requirements, such as temperature conditions and storage capacity.
- Confirm and secure: Once everything is set, we’ll reserve your back-up space, ensuring your samples are protected.
Don’t wait — act now to safeguard your research!
From crisis to continuity: A case study in disaster recovery
During an ICH stability study crisis, a pharmaceutical company activated their Q1 Scientific disaster recovery plan. Samples were saved, timelines remained intact, and quality assurance was maintained thanks to a seamless sample transfer and expert support from Q1 Scientific
Challenge: The stability chamber failure
A pharmaceutical company was conducting stability testing on a new drug product intended to treat a rare, life-threatening disease. The product was in the final stage of development and on track to be submitted for regulatory approval. At one point in their ICH stability study, the company discovered that one of its stability chambers had malfunctioned due to a faulty sensor that caused the temperature and humidity levels to fluctuate erratically. The malfunction continued unnoticed for several hours, affecting hundreds of samples. The pharmaceutical company was unable to leverage its own in-house backup equipment, as all redundant chambers were already at full capacity. The pharmaceutical company faced the risk of losing valuable data and samples, delaying its regulatory filing, and compromising its product quality and patient safety.
Solution: Swift and compliant sample transfer
The pharmaceutical company was already an existing Q1 Scientific client and had space reserved in the event of an emergency to transfer samples within a 24-hour timeframe of the condition failure, remaining in compliance with ICH guidelines. This proactive approach of the customer reserving emergency backup storage space at Q1 Scientific is an example of many of our clients’ risk mitigation strategies, highlighting the benefits of having a disaster recovery plan that includes a contingency agreement with industry leaders who offer a reliable and compliant stability storage service. As a result of our partnership and successful sample transfer to Q1 Scientific, the company was able to continue its stability testing program without interruption or deviation.
Outcome: Effective risk management and relief
By having a disaster recovery plan that involved Q1 Scientific as their backup/disaster recovery stability storage provider, the pharmaceutical company:
- Saved significant time and cost resources by avoiding the need to repeat or extend the stability testing program.
- Kept their regulatory filing on track, bringing the product to market as planned.
- Ensured the integrity and safety of their stability samples and data.
- Felt a great sense of relief in successfully mitigating the crisis and ensuring the project’s continuity.
- Maintained their product quality and patient safety standards.
“Q1 Scientific has provided us with an excellent resource for stability storage. The staff are very knowledgeable and friendly and show a great interest in our business. The security provided for critical samples is first class and allows us to know that our samples will be kept at the required conditions for the duration of our stability studies”
– Leading Pharmaceutical Company
Don’t wait for a crisis. Learn more about reserving back-up space to protect your research.