Electronic Archiving, a new Paradigm

In pharmaceutical R&D, the use of electronic media to generate, process, and display data and text has been slowly progressing over the past decades to the point where a substantial part of source data and original documentation is generated and stored electronically. There is now a common understanding that the accumulation of electronic source data and the evolution of electronic documents to include more “intelligence” create the urgent need for both electronic signatures and digital archiving to preserve the integrity of originals. Digital records management and archiving create a new paradigm in the world of records preservation.

American Pharmaceutical Review, Sept/Oct 2005, Volume 8, Issue 5, pages 10-16

To e-Archiving and Beyond

The pharmaceutical industry – the largest producer of regulated documentation – embraced e-technologies decades ago and has moved on to filing fully electronic marketing authorisation applications in most countries. But, paper has not disappeared from our lives and questions about the kind of records we retain and how we deal with regulatory and legal requirements, long-term retention or with business needs for knowledge management remain. In other words, how do we perform record management in today’s changing world, and has the landscape changed since the earlier assessments, five years ago? READ MORE 

A Robust Methodological Approach for Replacing Global Electronic Document Management

This article describes the vision, approach, and methodology used to select new vendors and prepare for implementation of the new environment. As is often the case in merging pharmaceutical companies, new technology, harmonized processes, and process efficiency across the integrated departments are driving the change.  Mergers pose problems as the staff and tools are integrated from two previous companies. The selection of future systems must take into account the heritage from each and help form these companies into a new unit that can leverage the best of both worlds. In this case, the existing tools for electronic document management (EDM) and submission management (SUBM) were not found to be sufficient for the new business... READ MORE


Measuring Success

How do you pilot a business like Pharmaceuticals? Our marketing model is a unique combination where one party gives permission to market the product (health authorities), another party selects the product (prescribing physician), a different party decides the price (government), another party uses it (patient), and yet another pays for it (insurance). How do you make sure that spending a billion dollars today will, in 20 years from now, produce a drug which will help people fight disease, will reimburse all its development costs – as well as the costs of 99 other unsuccessful drugs – create a profit for the shareholders, and make the company a place where people want to work and feel happy? . READ MORE

 Why small pharmaceutical and biotechnology companies can (and should) acquire an EDMS
For the past two decades most, if not all, documentation supporting the development, registration and marketing of pharmaceutical products has been generated in electronic format. The large companies realized very early the need for some system that would allow the management of these documents and their secure preservation. These tools were described under the acronym of EDMS (electronic document management systems). READ MORE 
   © Copyright MAIA Consulting 2013