Archive Solutions
Centralized & Custom Programs
GXP Bio provides both centralized and custom on-site / off-site long-term archive solutions that manage the entire lifecycle of our client’s regulated material. Many of our clients seek to consolidate their decentralized research and development material for secure preservation, to increase visibility and access to support new products and/or evaluations, and to standardize their regulated material management program. Contact us today to explore how we can assist you in achieving your operational excellence goals.
Compliant & Rapid Access
All our long-term archive solutions are supported by our BioSys 21 CFR Part 11 compliant validated regulated material management system that provides our clients with secure online portal access and that can also support routine data transfer to keep our clients preferred system in synch. Please contact us today to learn more and to explore how working together can take your archive program to the next level.
Proven & Reliable Service
We have expertise in the planning, development, and operations of regulated material storage facilities that are GXP and OECD compliant. This expertise has built a truly unique network of restricted access facilities that offer a wide range of regulated environmentally controlled and monitored storage areas, project, and program management capacity. These facilities are monitored and supported 24x7x365 by redundant 21 CFR Part 11 compliant systems and an emergency response team. We have ample storage capacity and the resources needed to craft flexible centralized and custom solutions to meet our clients’ long-term needs for regulated material management.
Specialized Logistics
GXP Bio offers technicians trained and licensed in regulatory compliant packaging and global distribution of hazardous, radioactive, secure cold-chain and/or controlled substances with applicable permits and chain of custody documentation.
Flexible Indexing
We offer flexible digital indexing for all client material using proven SOP’s, embedded quality control procedures, and a validated inventory management system to ensure the accuracy of your inventory, facilitate discrepancy resolution, and standardize your centralized or custom material management program. Our validated material management system provides secure online access to manage your inventory, submit work requests, and generate standard or custom reports.
Life Cycle Management
We store all material in restricted access, purpose-built facilities that offer validated environmental monitoring across a full range of storage environments (e.g., Controlled Room Temperature, +4°C, -20°C, -80°C), back-up equipment and power sources, fire detection and suppression systems, emergency response teams, and business continuity procedures that ensure secure long-term preservation.
Project & On-Site Services
We offer professional services for material management such as: partnering with certain labs for sample aliquoting and processing; special off-site project support; site relocations; custom programs; support for sample licensing, sales, and acquisitions; and secure disposal through incineration.
