With an ever-increasing amount of regulated documents, a robust and user-friendly EDMS is indispensable for preparing the documents efficiently for submission or labelling.
Consolidating and unifying your Electronic Document Management System will further help streamline the submission process – for instance by generating better overviews and supporting re-use of documents.
Document management is a core discipline for all pharmaceutical companies. In Regulatory Affairs, document management is typically done in three different systems, an Electronic Document Management System (EDMS) for authoring and approving documents, an eCTD system for publishing and submitting the documents, and a Labeling system to manage the labelling process. However, there is an increasing need for connecting or even combining these systems, both for reasons of efficiency and cost.
Moving electronic common technical document (eCTD) closer to EDMS
eCTD systems have been around for many years and have delivered many business benefits. However, managing the various country-specific requirements is not easy and often leads to many costly systems updates to accommodate for changes in these specifications. Moreover, for many pharmaceutical companies it is a challenge to view the direct connection between individual documents and the submissions that they appear in. NNIT helps to draw EDMS and eCTD closer through smarter interfaces or by moving to a unified platform, whereby the link between documents and submissions can be preserved. This improves transparency, control and re-use of documents.
From labeling to structured labeling
In labeling, there are strict requirements regarding the exact labelling format and content, and these requirements differ significantly from country to country. It is a complex and resource-heavy process.
NNIT focuses specifically on structured labeling to facilitate this process. By structuring the content as data, changes in the data will automatically update the associated documents correctly rather than having to rewrite several documents. This significantly reduces both risk of errors and the time spent.
NNIT gives advice on how to move to this new paradigm of creating labelling content and which technologies best support you in this endeavor.
Combining documents with data
Today, EDMS is no longer just a question of managing documents, but of using the information and metadata of the documents in smarter ways, both to make data-driven driven decisions about the submissions and to re-use the information in smarter ways to speed up the submission and labelling processes.
NNIT focuses on seeing the regulated documents in EDMS in the context of the entire process in RA and the many uses that this data can be put to in the surrounding systems and processes.
Document management and Regulatory Affairs transformation
EDMS, eCTD and Labeling are all typically complex and costly IT systems that are difficult to operate and upgrade. By integrating or consolidating these systems, document management plays an important role in the transformation of the Regulatory Affairs IT landscape towards better transparency, flexibility and efficiency.