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
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?
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.