Technology
Compliant Regulated
Material Management Solutions
We have decades of experience in defining, building, validating, and maintaining scalable regulated material management systems. We understand your need for a high availability system that you can securely access 24×7 to manage your regulated material in our biorepository facilities or at your site.
We built-in multifactor authentication, tamper proof audit trails, powerful search and filter capabilities, and a way to submit trusted work requests for our biorepository services in our validated and hosted regulated material management system.
We also offer a cost-effective hosted Software as a Service (SaaS) regulated material management solution with support services that allow you to plan, migrate data, validate, and maintain a system that can increase compliance, visibility, and control of regulated material at your site(s).
FAQs
Have questions?
What industries have to manage compliance of regulated materials?
Most academic research institutions, biopharma, healthcare, and agricultural sciences organizations and/or their contract partners who conduct regulated research, development, manufacturing, and distribution activities have requirements to manage their regulated material in a compliant manner.
Should I use a regulatory compliant system to manage my regulated material?
Yes. Using a validated system to manage the chain of custody for your regulated product research, development, and manufacturing material is required in most countries that you will market and distribute these products.
What regulated material can your solution manage?
Our solution can manage the chain of custody – including many attributes – of regulated product material created throughout the research, development, manufacturing, and distribution lifecycle.
If I am a client of GXP-Storage, can I use your solution.
Yes. Our solution is part of our standard biorepository service delivery and there is no additional cost for using this system to access and manage your regulated material stored at our GXP compliant biorepository facilities.
Can I license a hosted version of your compliant regulatory management system?
Yes. Contact us so we can learn more about your requirements to determine if our hosted solution is right for you. We offer support services to assist you and your team (e.g., quality assurance and IT) to plan, validate, migrate data, maintain, and provide ongoing end-user training and support. We are dedicated to your success.
Does your regulated material management offer a secure portal?
Yes. We offer secure client portal access to your material stored at our GXP biorepository facilities.
If you choose to license our solution to manage your archive, biorepository, and/or other regulated material management workflow, we will work with you to configure a secure portal so that people you authorize can access and submit service requests for your site.
