Sinisa Belina of INFOTEHNA and Romuald Braun of Uanotau analyse the functionalities of the commercial enterprise document, regulatory information and quality management system packages available, while considering the holistic enterprise requirements of a life sciences company.

From 20 years’ intensive involvement in all aspects of enterprise document management system (EDMS) projects, it is clear that the vendor selection process has become vastly more complex. Requirements engineering techniques have evolved greatly, and techniques such as feature request management systems can help produce a system that fulfils requirements, budgets and timelines. However, insufficient upfront analysis may result in the implementation of inadequate functionalities, costly changes and wasted development efforts.

Initially focused on platform selection, and followed by a customisation phase, most current vendor evaluation processes follow best practices or an out-of-the-box approach. Today, cloud computing adds another dimension of uncertainty, and can lead to unsatisfiable expectations by oversimplifying aspects of validation and total cost of ownership. Experience shows the error of using methods learned from e-commerce to manage EDMS projects involving multiple business partners. It is time to call for holistic solutions that reflect configurable functionality based on best practice modules; DMS with configurable granularity and attribute definition for multilingual companies; central, cross-functional repository; submission planning and tracking; quality management processes support; dossier compilation and publishing in electronic common technical documents (eCTDs) and non-eCTD electronic submissions; product information management; master data and data standardisation based on XEVPRM and IDMP; and business intelligence features supported by dashboarding and reporting.

The availability of highly integrated solutions encompassing these features will reduce most of the vendor-assessment-related risks, as such software packages will have longer life than a combination of legacy solutions.

Study shows up inconsistencies

The figure (above, right) shows the results of an evaluation of available and recently discontinued software packages (on premises or off; centralised or distributed). The study also considered possible combinations of packages, assuming that only vendors with complementary functionalities would partner.

These evaluations showed a very inconsistent picture, with some ‘green islands’ representing full functionality in certain areas, and a lot of red and yellow representing weak or no functionality in others. However, some packages already show very broad and holistic capabilities.

This complexity is created by inconsistent terminology in the requirements language and vendor responses. Given the incompatibility of long-term industry objectives and short-term vendors’ ambitions, vendor selection is very often driven by one of the following factors:

  • (un)awareness of what’s possible and what’s available
  • inconsistent understanding of requirements
  • unrealistic expectations of selection process timeline and the effort involved
  • internal (political) drivers hoping to leverage existing solutions
  • vendor promises related to available functionality and next release
  • decisions based on demonstrations and presentations instead of real-life case studies.

In recent years, it has been suspected that the correlation between compliance risk and vendor size might have been fabricated by the major players. In the meantime, many ‘big-name solutions’ have disappeared from the market or been discontinued due to unrealistic expectations.