Markus Schneider, Managing Consultant and Life Sciences Expert at fme AG in Frankfurt, is one of the leading migration specialists in Central Europe. He is leading a team of application- and content-migration experts specialized on the Life Science and especially Pharmaceutical industry.
It is a challenging time for many traditional pharmaceutical companies. The competiveness of the market place, the looming loss of patents, ever-increasing international regulatory requirements and pressure to lower the overall cost for healthcare – they all increase the burden and force these companies to find new approaches in order to survive in the industry.
Pharmaceutical companies are today driven to adopt strategies for reducing resources and costs, circumstances that have been tangible in other manufacturing sectors for some time. The expectation from IT departments is that they should support the business challenges and deliver cost-effective solutions without compromising quality, compliance, agility or flexibility.
Cloud computing seems to fulfil the promises of solving these business challenges and life sciences firms increasingly look to it for the universal remedy. However, how well does cloud computing coexist with GxP compliance and regulated environments?
At the end of August I was able to attend the BoxWorks conference in San Francisco, subtitled “The Future of Work”. I have to admit, I went there with only a little pre-knowledge and with the history (baggage?) of being a long-time Documentum consultant.
Let me start with a quick summary of the highlights:
Box Feed (available as Beta)
Box feeds allow you to get a stream of activities happening in the shared folders which the user can access. This is a nice collaboration function as are you are seeing the content of your coworkers directly in the stream. This has been missing for a while and Box is now delivering a first iteration with the possibility for you to comment on the documents.
In today’s world, companies need to act quickly and remain flexible. Cloud-based platforms offer the optimal basis for this. In industrial manufacturing, the use of the cloud has been established for some time. The life sciences industry is just taking off in this area.
The term »cloud« has been a constant companion in the IT industry for almost ten years now. But everyone has different ideas about it. Some of the definitions differ greatly from each other, so that every discussion about “cloud” starts with a joint definition of terms.
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
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.