The extensive procedural requirements of the U.S. courts for companies active on the American market were in place even before the recent Volkswagen exhaust scandal. However, the life sciences sector is affected by the e-discovery requirements just as much if not more so than the automotive industry that is currently the focus of attention. Plaintiffs were granted powers similar to those of state prosecutors with the amendment of the Federal Rules of Civil Procedure (FRCP) in 2006 – and not only in product liability lawsuits. Requests for information were expanded to include electronically stored information (ESI) which has far-reaching consequences for how information is handled in the company. A plaintiff (with the support of the courts) may demand the surrender of all relevant ESI from the defendant. This applies to standard e-mails as well as Office documents and text messages on smartphones, online content, and social media posts. Failure to deliver the information within the imposed deadlines or even the inability to identify relevant information and safeguard it against changes can lead to heavy penalties and the loss of the case, regardless of how the evidence may point. Public authorities and other jurisdictions are increasingly expecting compliance with e-discovery standards within the scope of requests and investigations as well. Only certain procedures are now being accepted for internal searches and the evaluations of documents. read more
Virtually every industry is currently facing the challenge of digital transformation, including the life sciences sector.
But what exactly does the digital transformation entail and what consequences does it have?
When it comes to digital transformation, we talk about the ‘third wave’ of IT. The first wave was the introduction of the server-client architecture which followed the mainframe principle. The second wave was Internet technology, and we are now talking about a third wave, that being smart, networked devices.
As I see it, digital transformation is based on two main pillars:
- On the one hand, we are finding that the pace of sensor development is gaining speed. They are becoming more accurate, more specialized, and more compact. But most of all, they are growing more affordable, meaning they can even be used as disposable products. Sensors are used everywhere, whether in industry, in cars, at home, or in the field of medicine. They measure sounds, vibrations, movements, temperature, pressure, humidity, and much more.
- The second factor is that IT is now readily available and easy to consume in any quality and quantity and at any time. The vast amount of data produced by sensors, mobile end devices, traffic management systems, and much more can nowadays easily be stored centrally and can be analyzed in a matter of seconds, in some cases even in real time. Correlations obtained from these data produce unprecedented findings about such matters as production processes, causes of illnesses, and the usage of wearables.
The digital transformation is driving industry change
These new findings are putting many companies in a position to rethink their business processes and models: read more
There are different ways of how to manage documents using Document Management Systems (DMS). Which one is the best for your company? This blog discusses the question if it makes sense to manage the full document lifecycle in the DMS, or if only the most important document versions should be stored in a DMS, having the other documents created, managed and stored in other places.
I vote for the full approach. Why?
It is the collaboration idea that requires multiple users to work with the same document and have a full version history of information for all previous versions. The benefit of using a transparent chain of document versions is often underestimated. Even SharePoint technology is using this feature.
Document Management Phases
In the creation phase, Document Management Processes have special document access rights, which need to be considered differently, as you do not want to distribute the document to a larger audience, but at the same time you like to collaborate with the group of authors.
At this stage the system must be very flexible and user-centric. The focus here is on user interactions, where you prepare all meta-information in an intuitive way. This changes, when the document itself needs to step into a higher status and when leaving the authoring phase.
Now, it is more important that the document is following a workflow process for reviewing the document using the 4-eyes principle. And last but not least now follows the approval of the document for a designated business reason decided by a group of persons – the Approvers. read more