he Document and Records Management (DRM) Community is focused on documentation management best practices, emerging technology and concepts, architecture, workflow, records retention, multi-purposing of information, and document repositories. The DIA DRM Community objectives, stated in our charter, are to:

• Provide a dynamic forum to encourage professionalism in document management, records management, and information governance through the sharing of knowledge, expertise, and experience.
• Exchange information and discuss current issues related to good document management, records management, and information governance practice.
• Promote good document management, records management, and information governance practices that align with regulatory requirements and expectations of regulatory inspectors.
• Develop supporting materials to assist in the understanding and interpretation of pertinent laws, regulations, and guidances.
• Publish position papers on current issues, new regulations, emerging trends, and technology evolution.
• Influence the regulatory environment as it pertains to the active management and archiving of documentation.

For more than ten years, the DRM Community has been successful in the creation, maintenance, and broad industry adoption of three reference models that promote consistency in the management of documentation created in support of the development of investigational products. These two Reference Models (EDM Submission Reference Model and Trial Master File Reference Model) and Framework (for the Destruction of Paper), were created by industry, for industry, are constantly maintained to reflect evolution in the industry and regulatory landscapes, and are available free to the public on DIA’s website.

Please note: The Framework for the Destruction of Paper is in active review and we are seeking volunteer contributors; contact the DRM Chair through the Community website to participate.

Who Are We?

The DRM Community has nearly 300 members. Six leadership positions guide members toward our objectives; two co-chairs plus communications, membership engagement, programming, and education coordinators. Our global leadership team has over fifty years of experience in the document and records management profession. The DRM Community leadership team elected this past April is currently outlining its objectives for the remainder of 2018.

US and EU Conferences

The 2018 eDM 2018 – Clinical and Regulatory Operational Excellence Forum, titled Electronic Data and Document Management – The Next Industrial Revolution, will be held November 28-29 in Barcelona, Spain. The Regulatory Submissions, Information, and Document Management Forum 2019 will be held next February in Bethesda, Maryland.

Come Join Us!

Management of documentation is a truly global effort. We are always looking for engaged members to join our community, contribute to our impact on industry, meet our objectives, and propose new ones. We hope you will take advantage of the connections, information, and collaborations that participation in our Community can offer.