Manufacturing Material Storage, Collection, and Distribution
EPL Archives, LLC provides professional services to assist our clients in the collection, cGMP compliant storage, and distribution of regulated manufacturing material.
Specialized Material Logistics
We provide regulatory compliant specialized logistics services to support consolidation and lifecycle management of manufacturing material such as active pharmaceutical ingredients (API), legal holds, lot retains, and controlled substances; as well as preservation of applicable third-party documentation (e.g., batch records). EPL’s personnel are trained and licensed in regulatory compliant packing and global distribution of hazardous, radioactive, secure cold-chain and/or controlled substances with applicable permits, customs clearance experience, and chain of custody documentation.
Flexible Material Indexing
We offer flexible and robust digital indexing of manufacturing material by trained personnel using our proven SOP’s, imbedded quality control procedures, and validated LabTrak® material management system to ensure the accuracy of your inventory, facilitate discrepancy resolution, and standardize your inventory to maximize savings.
Compliant Material Storage
We store all manufacturing material in our 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, Vapor-Phase LN2), back-up equipment and power sources, fire detection and suppression systems, emergency response teams, and business continuity procedures that ensure secure long-term preservation.
LabTrak® Material Management
Our enterprise-class LabTrak® material management system provides secure online access to manage your manufacturing material inventory, submit work requests, and generate standard or custom reports. This is a powerful proprietary system that was developed by EPL over many years to support its diverse client requirements for material management on a global scale.
Regulated Data Management
We offer regulatory compliant data management services for paper data and electronic data on physical media (e.g., CDs, DVDs, and other storage devices) that include but are not limited to: material receipt and inspection; standard and custom indexing; storage in vaults that are temperature and humidity controlled and environmentally monitored with a validated system, protected by FM200 and/or Nitrogen gas fire detection and suppression systems; digital document imaging; retrieval and distribution of records.
Lifecycle Manufacturing Material Management
We provide support services for manufacturing material management such as: designated storage for legal holds and lot retains; scheduled lot retains disposal; and storage and distribution of clinical trial and/or diagnostic kits. EPL also offers other products and services such as special project support, site relocations, custom programs, independent study audits, review of documentation for international submissions, and material licensing, sales, or acquisition support.