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How classic EDM hurdles will affect your eTMF implementation

​Article by Thomas Hornbæk Svendsen,
Principal Consultant, NNIT


Even though Electronic Document Management (EDM) systems have been around for decades, and even though the use of EDM systems should cater for well-managed, version-controlled, and secure handling of documents, we are still struggling to make the document life cycle truly electronic, transparent, and process-supportive. As the use of EDM systems expands to support electronic trial master files (eTMF), the challenges will appear within this domain as well. This article pays a visit to the traditional claims of EDM and establishes a list of predominant hurdles that an eTMF project must overcome.

Necessary EDM functionality is available – but processes are not fully implemented

The basic functionality comes with the standard EDM applications: capture, maintenance, storage, and distribution of digital content, such as documents, e-mails, and files. EDM systems come with check-in/check-out features, a detailed and granular security concept, configurable workflows, and life cycle states for edits, review, and approvals, and also 21 CFR Part 11 support, if needed. Everything is at hand for us to prepare, maintain, and safeguard digital content across the organization – as well as when we need to share content with someone outside of the organization.

For some reason, however, we still struggle to administer documents, e-mails, and files – especially in ad hoc situations where the process is not fully streamlined. We resort to e-mailing document copies to business partners for further editing, or we use a personal network
drive to draft an early version of a business critical document. This is human behavior performed with the best intention to serve  the organization. It reflects the need to bend  the process to deal with real-life situations.

Organizations that have adopted EDM system(s) to control and manage the eTMF will most likely face similar challenges within this domain as well. The eTMF is not only rich in content, complexity, and comprehensiveness – the intricate process of assembling, managing, and submitting an eTMF also calls for a wide range of collaboration and exchange of digital content.

All-pervading challenges affect the eTMF implementation

Digital content destined for the eTMF typically resides in numerous electronic and paper-based systems across locations in several countries. The extensive use of third party research organizations, investigators, and monitors challenges the process of controlling document versions, especially when paper documents are involved. Although challenges using EDM systems are unique to every organization, the following challenges are all-pervading:

  • Ad hoc collaboration with third parties.  Most EDM system implementations institute a collaboration gateway that allows for sharing content under a strict security paradigm. However, the gateway is often cumbersome to set up for short-term, cooperative agreements, and the analysis needed to define appropriate access and security measures  will probably not counterbalance the effort required. As a result, e-mails are used as an alternative which potentially compromise the control, transparency, and security.
  • Enterprise-wide systems favor enterprisewide processes. Ideally, EDM systems should be implemented to support all processes that require management of digital content, such as documents, e-mails, and files. EDM systems are prioritized according to return of investment or to help achieve and sustain compliance – just as any other type of IT system.
  • The interplay between electronic and manual processes. Optimal conditions for efficient and cost-effective processes are best achieved when the process is kept entirely electronic. The moment you include manual steps (e.g., relying on physical signatures or off-system archival of documents) the process effectiveness will deteriorate significantly. The interplay between electronic and manual processes is complex and potentially error prone, and costs have the tendency to escalate when documents have to be managed in a physical format – it must be manually indexed and stored; it must be manually reclaimed; and it must be transported by manual means.

The struggle to provide full and efficient support for the process of assembling and managing  the eTMF cannot overcome the flaws of the IT systems. The systems needed are most likely available, including EDM systems that offer full support for the document life-cycle and collaborative platforms enabling seamless exchange of digital content across organizational boundaries. EDM systems, however, will primarily be implemented to support well-established processes, because they can prove the required return on investment.
For ad hoc processes, it is another story  – although they provide the glue that helps  the overall process toward completion, it is difficult to prove a credible business case,  if they were to be part of the EDM system implementation.

When the use of EDM systems expands to support eTMF, the challenges are inherited.  To compensate for the lack of efficient support of ad hoc processes, it is recommended, therefore, to establish and maintain solid support options to be used by employees and third party stakeholders. This will offer a reliable alternative to e-mails and personal network drives and ensure that the digital content is safeguarded.







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