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It Might Be Time to Rethink Your EDMS

Document Management 2.0

Document management is one of the core capabilities in any pharmaceutical company, and electronic document management systems (EDMS) have successfully delivered this capability in a secure and controlled way.  
However, a number of factors indicate that most EDMS are no longer suitable for adapting to new regulatory requirements and satisfying the changing business requirements in the clinical, regulatory, and quality departments. Moreover, new functionality and new underlying infrastructure and delivery models also fundamentally change the options at hand and set new standards for how document management can be done. 

New regulatory requirements affect EDMS

EDMS, like the pharmaceutical industry, has always had to adapt to the everchanging regulatory requirements. Yet, EDMS right now faces a number of requirements that are difficult to satisfy with a rigid document silo: 

  • eCTD v. 4 may not change EDMS fundamentally, but it is just one of many new standards that require a much more flexible EDMS in the future.  
  • The regulators will demand TMF documents in a more transparent, active, and directly accessible EDMS, which challenges the traditional role of EDMS as a controlled cabinet. 
  • The future ISO IDMP submission will also require an additional submission of some of central regulatory documents. 
  • The new EU data protection regulation will put extra emphasis on the control and oversight of personal data in documents used throughout the company.  

A holistic view on documents 

A lot of effort is put into authoring documents, but often the full benefit has so far not been reaped from putting these documents into use in the organization. This is currently changing now, as integration and new functionality allow a much more holistic view of the document, by actively tying registration information with eCTD documents, for example, and by linking quality documents with learning management systems, and hence linking compliance requirements with active training needs.
There is also an increasing insistence on the benefit of reuse of documents across business areas,  by adding mobile capture of trial master file documents at clinical sites, for example, and then reusing these documents in the regulatory submission. Moreover, reuse of information has also led to a revival of the vision of componentbased authoring of regulatory documents, especially with CMC, and labeling documents for which the business case is especially strong. 


Article written: 2017





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