EPL Archives

Biomaterials Best Practices Consulting

Preservation of the integrity of scientific sample assets is becoming increasingly important to research companies. Proper protection of biomaterials and documentation assets for research purposes requires the development and execution of a comprehensive, full lifecycle biomaterials management strategy and program.

EPL Archives’ (EPL) goal is to consistently pioneer new Standard Operating Procedures (SOPs) that incorporate innovative technology and methods for maximizing the quality and extending the life of biomaterials, biomaterials research data and related manufactured goods.

EPL is working to share certain SOPs that advance best practices within our industry as an active member of the International Society for Biological and Environmental Repositories (ISBER).

ISBER Best Practices

ISBER’s Best Practices for Repositories: Collection, Storage, Retrieval and Distribution of Biological Materials for Research (Second Edition), reflects the collective experience of its members and provides repository professionals with a comprehensive tool to guide them in their activities. ISBER Best Practices are reviewed and revised bi-annually to reflect advances in research and technology. They address:

  • Organizational requirements of repositories
  • Records management
  • Facilities
  • Storage equipment and environments
  • Quality assurance and quality control
  • Safety
  • Training
  • Biological material tracking
  • Packaging and shipping
  • Specimen collection, processing & retrieval
  • Legal and ethical issues

While adherence to ISBER Best Practices is strictly voluntary, some aspects of biomaterials management are governed by national, regional and local regulations. By partnering with EPL Archives, you get the best of both worlds: access to industry best practices and full regulatory compliance.

The EPL Methodology

EPL identifies key industry guidelines, high-profile regulations and important industry standards that provide an overall “best practice” context to guide our clients’ biorepository management program strategies. Our consultants assess your biomaterial management practices vs. industry best practices then identify your highest risks – to plan and prioritize accordingly.

EPL’s consultants address:

  • Assessment – Of current practices, facilities and vendors as they relate to compliant industry best practices with recommendations and action plans for areas needing improvement.
  • Policies and Procedures – The definition and establishment of policies and standard operating procedures (SOPs) that facilitate and enforce compliance and best practices; including roles, responsibilities and procedures. Once developed, these policies and procedures must be communicated across the entirety of the organization, clearly and consistently.
  • Retention – A comprehensive biorepository retention schedule specifies which biomaterials need to be retained for business and regulatory reasons, how long they must be archived, when they may be destroyed and who has authority to do so.
  • Indexing and Access – The value of your investment in a compliant biorepository management program hinges on your ability to quickly retrieve information for business, litigation and compliance purposes. Bar coding and other techniques can be put in place to facilitate quick location and save costs.
  • Logistics – The requirements for transporting biomaterials safely and effectively without degradation between locations along with the documentation necessary to ensure compliance and chain of custody.
  • Disposal – Often overlooked, timely, consistent and environmentally responsible disposal is critical to an effective biomaterials strategy as it closes the loop of compliance while also reducing storage costs and legal exposure.
  • Security and Privacy – EPL maintains industry-leading security standards for its facilities, technologies and biologistics systems, including real-time tracking and auditable chain-of-custody controls to ensure the security of biomaterials in transit. We will work with you to incorporate new regulations into your compliant biorepository program, and drive the organization-wide behaviors to help protect your clients’ and employees’ private information.
  • Audit and Accountability – The final best practice area addresses the need for organization-wide accountability for biorepository management and integrates biomaterials management into your internal audit process.

By building a comprehensive biomaterials program based on industry best practices that integrates training and communication along with a reliable checks-and-balances system, you will enjoy a higher likelihood for success and will know whether your program is working the way it was designed.

EPL has helped organizations in the successful implementation of compliant biomaterials management programs. We understand the challenges our clients face and we’re ready to apply decades of expertise and insight to help you address your specific challenges. Contact us today to put the power of EPL to work for your organization.