Feb 20, 2018 | by Steffen Fruehbis | 0 Comments

In the regulated life sciences environment, the management of controlled documents such as SOPs (Standard Operating Procedures), procedural instructions or work instructions is of great importance. Change management processes ensure that these documents are properly revised, approved, trained, distributed and, where necessary, suspended. In addition to well-known use cases within change management, there are special cases that are handled differently from company to company.

One of these applications is the rare case of so called Effectivity Hold. read more

Oct 24, 2016 | by Markus Schneider | 0 Comments

Checkbox

When introducing new systems or adding new areas to a new system usually data migrations are needed to integrate the data from the old system or other areas into the new system. During such data migrations often a migration tool is used to get the data from the source into the target system. This migration tool transforms the data to be compliant with the new system and imports the data into the system.

In such a scenario generally these questions come up: How to validate the data migration? Do we need to validate the tool itself? Do we need to validate all details of all rules and functionalities that are available in the tool and could be used in theory?
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Oct 5, 2016 | by Daniel Pelke | 0 Comments

Finance concept: pixelated Folder icon on digital background, 3d render

I’ve been in the Document Management System (DMS) / Enterprise Content Management System (ECMS) market for more than 20 years. Sometimes very focused on a specific aspect e.g. Technical Documentation, sometimes more general e.g. ECMS platform and sometimes with focus on an industry segment e.g. Life Science. I have seen a lot of vendors, products and technologies coming and going. The latest acquisition and certainly the biggest one was just a week ago. Hopefully, this will not reduce the power of innovation.
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Sep 23, 2016 | by Dirk Bode | 0 Comments

Documentum-logo

Interesting announcement from Alfresco. They started an aggressive > swap out program against Documentum pushing the fear that Documentum is going away or going south soon. First of all, Alfresco is a really good ECM platform – fme has been an Alfresco partner for many years. There might be good reasons for the one or the other company to decide to change their ECM platform within the next weeks or months, but it should have nothing to do with the OpenText acquisition. Fear has always been a bad advisor. Documentum is not going away any time soon, or why do you think OpenText payed 1,6 billion USD? They have to keep up the flow of maintenance money for quite some years to make the deal work.
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