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The end of day 1 – way too much information

July 9th, 2017 Comments off

My first PartnerSummit day at OpenText. Wow, that was heavy. There is so much to hear, think, discuss that I’m beat. Lying in my bed in the hotel to have some quiet (with the live band rocking downstairs😬) trying to sort all the info I gathered today and see how I can make this into a structured blog…

Maybe I need some data analytics to define structure, or get some concepts groups going to get relevance in my information search? For people who know me, they know it is not easy to structure my brain and no artificial intelligence will be able to work with this mess, so I’m stuck to my own brain and see what falls out.

The task I set out to accomplish today was to identify at least 4 products that would be a great addition to our portfolio. But after one day and way (WAY) to many products, I must admit: this is going to take a little bit longer. 😀

But the simple joke about my brain is so relevant for the journey we as a consulting company are on, that this will be the red line for this blog. The focus of Informed Consulting is very much on helping clients identify and address/manage their compliance demands. Supporting their journey of controlling the information processes that are relevant to being compliant. It does not really matter if you are in the life sciences space, an engineering company, a government agency or a bank. Our clients all have growing demands to meet their industry specific compliance demands. Until recently (1-2 years) Documentum could fulfill most of the demands and that was what we offered. But times are rapidly changing, even a mid-size pharma company has a enormous amount of info that needs to be managed and reused and just a ‘simple’ ECM system, meta-data taxonomy and search will not do the trick. We need to be able to give the client a total experience that will give them the ability to fit their compliance need in their overall EIM vision and tooling to guarantee the best experience, both for users and for the company.

Hey, that sounds familiar: Connecting people to the enterprise. The slogan that has been our vision the past 7 years is still, more than ever, alive!

But why, if we have been doing this already for years, is change needed? We live in a spectacular time. Simply put, on both sides of this equation (user and enterprise) the demands are exponentially growing. That, topped with a more than exponential growth in data, demands a total vertically focused solution, specific for the client. NO, not custom built, but a carefully packaged set of products, specifically targeted at the client’s needs. The challenging task of the new ECM Consultancy firms is not only to have the best developers or configurators. No, it is to have the best architects who can create an out-of-the-box, total solution, based on a predefined set of products, all handpicked and configured (composed) to meet the needs of that specific customer in that specific vertical market and to have an implementation team that understands the vertical and the vision of the architect and is able to deliver that before a very time sensitive deadline.

So that is what we at Informed Consulting have been doing the past years and we have a clear plan how we can deliver the much needed expertise to make that total solution. And now that Documentum is part of the rich set of products of OpenText we can rapidly deliver this total solution based on the products from OpenText combined with our tailor-made products for specific markets like our Quality Management Solution for the life sciences market.

For a life science company that total solution will include:

  • Documentum life sciences suite
  • eQMS express
  • SharePoint connector for Life Sciences for easy communication with partners in partner exchange
  • iHub for analytics to support that quick overview of all the states of the information and processes and manage and control every inspection
  • Decisiv to manage easy enterprise search not only in their ECM system but also in systems like their LIMS system. This is no eDiscovery but real AI driven enterprise search.
  • Blazon for regulator approved renditions
  • Marketing management that works with the ECM content
  • Customer communication management to streamline and audit all complaints and inspections
  • InfoArchive to really archive the old documents and make sure they stay compliant

And the list goes on and on. Sure, no client can do it all at once, but we have road map that will fit any client!

So, a great first day, with a happy partner and a SUPER road map for Documentum makes it complete.

Hope we can continue this happy flow for 6 more days!!

A Case of Component Based Authoring

September 30th, 2015 Comments off

Component Based AuthoringYesterday afternoon I attended an EMC webinar about their Next Generation solutions for Life Science, when a slide passed by about Component Based Authoring. It was a different way of expressing the same subject Jeroen van Rotterdam addressed recently in his EMC Spark blog called ‘Who is using Word?‘ From that blog, comes this quote:

Then there is the trend towards targeted point solutions with very domain-specific capabilities to create these smaller chunks of content. A generic word processor is far from efficient in this scenario, and even harder to customize with the desired user experience. Content creation applications are so much more powerful in a business context and becoming less focused on text.

It’s fun to read about a trend – in this case Component Based Authoring – when you’re already practising this approach. It feels for me as if this is the only way forward in case based solutions being delivered today.

My current project is implementing an EMC xCP based solution to support a decision making process where each decision is backed by carefully build cases.

In its previous implementation, documents were the content containers. A lot of copying and rewriting was taking place. A cumbersome and error prone way of working. We didn’t investigate it, but if I were to place a bet, I would say that it’s almost a guarantee that each document is formatted uniquely and it’s highly likely that not every document contains the mandatory information. The flip-side of the coin is, that this freedom is very well received by the end-user who is using Microsoft Word, a tool perceived as very user friendly and productive (don’t get me started…), to let his creativity flow.
You could argue that the needs of the end-user are prevailing over those of the enterprise. At Informed Consulting we believe that connecting people and the enterprise should be a win-win situation and is key to success.

With the new xCP solution we’re applying Component Based Authoring and Word is now only needed for the supporting documents. Not for the key information of the case. That key information is divided into logical components and authored independently. With this approach we created a balance between both user and enterprise needs. But in order to achieve this, more is needed than just solving the challenge of business process re-engineering. In fact, in this case the process is hardly changed.

Once you know what key information you need to capture, it’s time to let the UX (user experience) designer do her thing. My colleague Sandra did a tremendous job with the key users, to design screens for both capturing and displaying information. There has to be a natural order in the information that fits the way of working in the business. This means defining where on the screen a content component is positioned for a particular role (yes, different roles will typically lead to different positioning…), which content components need just plain text formatting and which need rich text to be able to add lists, mark text bold or even include hyperlinks but on the other hand prevent the usage of fonts other than what the corporate style-guide dictates. It means defining where you need to restrict input to predefined taxonomies (or just simple drop-down boxes populated with values) and where you need supporting wizards. A sample of the latter is one where the user provides answers and numbers after which the system draws a conclusion that is used as input for the decision. To cut a long story short, information with a good user experience will help to make the transition into component based authoring smooth.

Another key aspect is the transition from paper to digital. A topic on its own. In our project we opted for a gradual transition because it’s more than a business process change to replace meetings full of annotated documents, prepared off-line over the weekend, with information accessed digitally through tablets and laptops. As an intermediate, the individually authored content components are aggregated in PDF/A documents. These documents are available for on-line reading as well as printing. It’s now up to the business themselves to execute the behavioural change process. In the mean time they can still print and scribble away where and whenever they want.

The third aspect I want to mention is archiving. Although it should be part of your business process re-engineering, it typically isn’t. Too often archiving is not seen as a business process. But even if it is, it’s a beast of its own. Still today it is common practice to archive ‘just’ documents. With component based authoring, you can no longer think in terms of archiving documents. Neither can you think in terms of archiving these content components on their own. They have relationships with other content components and together they have meaning. A content component that holds the annotation of an approval, only has meaning in its context. Archiving thus needs to evolve into Contextual Archiving whereby containers are archived and these containers include the appropriate content components as well as their relationships. Rethinking needs to be done around the purpose of the archival and the retention policies. How can you meet the archival goals for a case if key information in that case needs to be destroyed before the case itself gets destroyed? And what will regulators say when you include a content component into multiple containers which are managed independently and whereby not all (logical) instances of the content components are destroyed simultaneously? When you think about it, component based authoring reveals what has been hidden under the covers of a Word document for a long time: we didn’t manage the information but only the container that carried that information…

Times are changing in the ECM playing field. New ways of working, progressing technology, distributed collaboration and blurring boundaries pave the way into an interesting future. Next-Gen ECM / Next-Gen Information Management… Welcome into my world!

 

This post also appeared on LinkedIn.

Day 4 and 3 before it begins

May 3rd, 2015 Comments off

Yesterday I missed the opportunity to write my blog. Packing was on the menu for the evening. The past few days I could take those 30 minutes to write my blog, but now I had to make sure all items for our booth where packed and ready.

Two laptops, a hub, a lot of flyers and some nice give-aways. Thought I was ready but then I remembered, I needed to finish the last tests of our Office 365 demo with SPA4D and our SharePoint LSQM integration solution. The first is easy. I have given this demo probably 50 times now and all with great success. Our integration with LSQM is a different matter. We are just releasing this together with the Live Science team of EMC – EDC.

The business case is simple but perfect: within a pharma company, a large group of users need to read the SOP’s and other important documents. This needs to be in the audit trail. This TBR (To Be Read) is a very basic function within Life Science. Normally the user needs a full LSQM license and needs to be trained how to operate it. That is not easy, as they might use the system only 2-6 times a year. On the other side, most of these users use SharePoint, they like it, understand it and are fine working with it. So the task is simple: create the TBR function with SPA4D and the answer is perfect. A simple task for users to perform and after the sign-off, a record in the audit trail is added for this action.

But that was the easy business case. What is much more interesting is the ability to service all partners in the life science ecosystem of a company. More and more pharma companies are just managing the process and out-sourcing a lot of work to partner companies. These partner companies come in different sizes and shapes, but also both in very tight or very loose relationships. But for almost all of these companies it is mandatory that they need to be able to read, comment and sometimes edit or create regulatory documents. This demand calls for a set of options a company can select from.

1) if the partner is fully trusted and you have a full working relationship, you might want that partner to have direct access to a subset of documents within Documentum. This needs to be a much simpler interface with preferably a lot cheaper cost-base as these users might change frequently. The interface should be simple and easy to use. The access needs to be possible within the extranet of the pharma company or via a cloud based solution like Office365.

2) if you work on a less frequent bases or less intensive manner with the partner, you might decide that the partner does not need to have full access to the site, but only read only access to a part of the site and should be able to submit documents to be added to your quality system. Again this should be a cost effective interface and simple to use. Because of the more limited relationship it should suffice that only the high level actions from the partner are captured in the audit trail, but versions and revisions should be fully available.

3) if it is a one-time or incidental partner, the partner should only get a copy of the relevant document(s) and should have a communication that is very controlled when documents are added to the system.

And this all makes together:SPA4LSQM-Partner eXchange (PX).

Within the easy to use SharePoint Interface you can decide what level of trust you give to a certain partner and configure the level of access to your QM solution. Trusted partners will get access to the full browse app-part of SPA4D to manage the documents they are entitled to and partners with less of a relationship will get only read-only access to Documentum and can submit documents via a process within a normal SharePoint library without having direct access to Documentum. If you want to make the integration even more loosely coupled you could share the documents with the partner via OneDrive for Business and not even give the partner access to the SharePoint environment, but still control the documents.

All very powerful and very good to demo.  So finally at 1.30 am all was tested and I was ready to go. Now I’m sitting in a Delta plane for the last hour before we touchdown in Vegas after a long, long flight. Hope to see you and let me impress you with a good demo of SPA4LSQM or join us in the raffle for a very nice toy.

Improving the DIA EDM Reference Model

November 18th, 2013 Comments off

EMC, by means of its Information Intelligence Group (IIG), has provided new solutions for Life Science. The solutions are based upon their Documentum D2 flagship.
Currently 2 solutions are out on the market: eTMF for managing Trial Master File and LSQM for managing Quality and Manufacturing.

Both eTMF and LSQM rely on their Life Science Core Document Framework (CDF), a data model for managing information in the Life Science domains.
This CDF is a core part of both solutions, like a data model is in any solution.
And like any other solution, success in using the solutions relies heavily on the fit of the data model.
To guarantee success, EMC has adopted the DIA EDM Reference Model to manage life science documentation in the Regulatory, Quality, Non-Clinical, and Clinical domains.

If you’re not working in the Life Science industry you might wonder: who is DIA and what is their EDM Reference Model?
Read more…