At EPL Archives, LLC, our Quality Assurance (QA) team has over 30 years of experience in regulated environments and oversees our archive / biorepository operations in North America and Europe in addition to supporting regular client and vendor audits throughout the year.
We maintain a rigorous quality program that includes regulatory and safety training programs, research material inspections, internal quality assurance inspections, validation inspections, vendor assessment inspections, and equipment maintenance inspections.
The quality program at EPL ensures compliance with applicable government regulations, internal Standard Operating Procedures, and industry best practices and guidelines such as Good Laboratory Practices (GLP), Good Clinical Practices (GCP), Current Good Manufacturing Practices (cGMP), Good Clinical Laboratory Practices (GCLP), Organisation for Economic Co-operation and Development (OECD).
The U.S. Food & Drug Administration (FDA); U.S. Drug Enforcement Agency (DEA); U.S. Environmental Protection Agency (EPA); Virginia Department of Health’s Division of Radiological Health & Safety; and the U.S. Federal Aviation Administration (FAA) have inspected EPL in North America. Our European location is inspected by the Agence Nationale de Sécurité du Médicament (ANSM) (human pharmaceuticals agency) and the Comité Français d’Accréditation (COFRAC) (for the GIPC regulating other chemicals).
In addition to regulatory inspections, we host quality assurance and compliance inspections throughout the year for clients in the pharmaceutical, chemical, petrochemical, agrichemical, and cosmetic industries as well as various trade organizations.
Our Biostorage Facility Network is comprised of biostorage facilities for the preservation of a wide range of research and manufacturing materials that require qualified storage environments that include but are not limited to: +21°C Controlled Room Temperature, +4°C Refrigerated, -20°C Frozen, -80°C Ultra-Low, and less than -136°C Vapor Phase Liquid Nitrogen. For paper and other data, stored on physical electronic media, EPL also provides humidity controlled environments to optimize long-term preservation. These storage environments are monitored by a validated environmental monitoring system and supported by dedicated Facility Management, Quality Assurance and Emergency Response teams.
EPL utilizes specialized equipment that is approved and/or qualified for use throughout the execution of its established Standard Operating Procedures. Examples of this equipment include but are not limited to: facility security equipment to maintain restricted access, emergency backup equipment, emergency power generators, fire detection and suppression systems, validated systems for material management and environmental monitoring, specialized material handling and testing equipment and mirrored computer servers to ensure the secure long-term preservation of our clients consolidated research and manufacturing material.
We provide quality program training to all of its personnel that includes but is not limited to: Standard Operating Procedures, applicable regulatory training; laboratory safety; universal precautions; chemical hygiene; blood-borne pathogens; controlled substances; radiation safety; and hazardous material handling and shipping.
EPL has developed its training material over time and may also use certain external experts to provide training. All EPL personnel maintain training documentation to demonstrate their on-going commitment to excellence.
We maintain and/or obtain certain permits, licenses, or compliance with other regulations in addition to applicable compliance with GLP, GCP, cGMP, and OECD and pertinent regulatory authorities holding jurisdiction:
- International Air Transportation Association (IATA);
- U.S. Department of Transportation (DOT);
- European Agreement for the International Carriage of Dangerous Goods by Road (ADR);
- Federal Motor Carrier Safety Administration (FMCSA);
- Unified Carrier Registration (UCR);
- Commonwealth of Virginia Controlled Substances Permit;
- U.S. Drug Enforcement Agency (DEA) Controlled Substance Permit;
- Convention on International Trade in Endangered Species (CITES);
- Virginia Department of Health’s Radioactive Materials Division — licensed to store and transport radioactive material – License No. 107-317-1;
- U.S. Fish and Wildlife Service;
- U.S. Department of Agriculture;
- Centers for Disease Control and Prevention; and
- U.S. Environmental Protection Agency.
EPL’s validated 21 CFR Part 11 compliant LabTrak® system is an enterprise-class material management application that provides a consolidated view of highly diverse research, development, and manufacturing material as well as related data.
LabTrak® is the product of over a decade of continuous investment. EPL developed this powerful technology because there simply was not a commercially available solution that could support the complexity of growing client and EPL business requirements.
Our clients use the LabTrak® secure web portal to manage their consolidated material and data. These clients use the account-based search, filtering, and virtual collection capabilities to rapidly respond to internal requests that support ongoing research and development activities.
We also use a robust environmental monitoring system that is also validated and U.S. FDA Title 21 CFR Part 11 compliant. This system allows EPL to monitor the environment where client research and manufacturing material is managed for secure long-term preservation and is part of EPL’s multi-channel alert and alarm notification procedures to ensure communication with designated Emergency Response team members.