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FirstDoc User Group 2011 – a look back at the conference – Part 4

Posted on 03/07/2011 by markjowen

Previous post: FirstDoc User Group 2011 – a look back at the conference – Part 3

In Part 3 of the FDUG 2011 series, I described the afternoon session of the first day, which included CSC’s Cloud offering, their UI Strategy, Performance and the social event. In this post, I’ll cover the sessions that took place on the last day.

Feedback

The morning started with feedback. The points compiled from yesterday User session were presented to CSC. These were graciously received, and even a few suggestions where made by CSC staff about ways they, themselves, could address the concern.

SPX in use

Following the user session, there was a panel discussion involving three of CSC’s clients that had implemented SPX in their environment. For more on SPX, click here (PDF).

It seems that while there was a lot of interest in the technology, and implementing it, this came from a very small group of people. This group, however, were very interested in a number of things, and many questions were still being asked after the session had ended.

eTMF

After the coffee break, another CSC customer gave a presentation on their journey from a manual system for managing their Trial Master Files (TMF) to an electronic system.

This was packed with some very interesting information, and it is always good to learn from others.

Total Clinical Solution

As discussed in earlier “Look back” posts, CSC are offering “Total Solutions”. The “Total Regulatory Solution” has been discussed, and now we had a chance to learn more about the “Total Clinical Solution”. Fransiska Darma (who I had met the night before) gave this presentation.

Often, in clinical trials, the research is outsourced to a Clinical Research Organisation CRO), and involves collaboration between the CRO and the pharma company. In other word – moving documents between the external CRO, and the internal groups involved.

To achieve this requires being able to capture document, and somehow allow the external party to upload it to the pharma company’s EDMS. Further to this, to allow for an increase in reporting and tracking, documents need to have an expansive amount of metadata.

As with CSC’s Total Regulatory Solution, CSC are trying to leverage the fact that they now have a full range of products to implement these “Total” solutions. For their “Total Clinical Solution” this includes making use of FirstDoc (on Documentum), along with SPX (on SharePoint), as well as other tools that facilitate planning and managing, tracking and reporting, and the auditing process.

Usability

This was another customer presented session. It was very, very interesting. In this case, the customer had done an Usability Assessment of FirstDoc 6.1.

The presenter started off asking why, when we search for, review & order something on a site like Amazon, we can do it easily, without any real effort, while, when do something similar inside a business, a 3 hour training course is required.

The presenter followed this up with the statement that “solutions should not require user to change their way of working for the sake of the system.”

To assess their own system (based on FirstDoc 6.1) the customer did 2 assessments, each time where 28 normal employees (i.e. not specially trained testers), were asked to perform a specific task – review & approve a document.

Using a tool that allowed the user’s mouse movements to be tracked, along with a camera that allowed the user’s face to be seen, gave the testers a good insight into how a new user uses an interface.

Some of the findings were shared with us.

These include the fact that the steps required to accomplish the actual task were not obvious. We were shown a film of the mouse movements of one of the testers as they tried to work out the steps required to complete the task. At the same time, a small screen showed the user face and body. There was a lot of “i know that feeling” laughter amongst the audience as we watched.

This particular customer had also created a mock-up of an improved design. This included less “clutter” and prompts that would guide the user.

On the one hand, having guidance can be very useful for users who are not familiar with the steps required for the task. And often, even after doing the task for a couple of times, if the same user did not repeat the actions for several months, then that same “learning time” is required. On the other hand, users who perform the task multiple times a day can get frustrated with guidance. In this case, what would be good is if the application had a “dummy mode” for new, or infrequent users, and an “expert mode” for those more “experienced” users. (This was something that was introduced into WebTop – a “simple” user interface, and a more detailed one.)

EMC & Record Management

Tim Marsh from EMC gave us a presentation on Records Management, and Information Governance, and the solutions and tools that EMC has in the area.

Validation

The last session of the day was presented by Peter Branstetter, a Senior Consultant from Arcondis.

Peter’s presentation was a very educational trip through validation. Starting with GAMP5 (Good Automated Manufacturing Process) he touched upon Risk-based approach, and the GAMP V model. Included in the journey we got to see example of this in use.

CSC offer a Validation Package which contains all the components needed to meet compliance. This allows the customer to fill in the details as required.

This session generated some very interesting discussions. It seems that “what”, or “how much” is required to meet compliance can vary depending on who is making the company policy. As such, the answers to some of the “do I need to do x,y, or z” questions were often – “that depends on what your QA department wants.”

This was the last session of the conference – about a quarter of the participants had already left. However, this topic, whether we love it, or curse it, was something that a lot of people wanted to know about, and Peter definitely seemed knowledgeable about it.

End of Session

So – that was the end of the FirstDoc User Group – Europe Conference. For me, this was one of the best FDUG conference that I have been too. I got a lot of value out of the sessions.

The FirstDoc User Group conference is organised by the FDUG – Europe Steering Committee This is made up of 3 representative from CSC Life Sciences customer base.

They did a really good job this year!

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FirstDoc User Group 2011 – a look back at the conference – Part 3

Posted on 02/07/2011 by markjowen

Previous post: FirstDoc User Group 2011 – a look back at the conference – Part 2

In Part 2 of the FDUG 2011 series, I described some business case presentations that a couple of CSC’s customers gave, and also talked about CSC’s “Total Regulatory Solutions”. In this post, we’ll cover some of the sessions that took place in the later part of the day – CSC’s IT Strategy (including their foray into the Cloud, and their User Interface Strategy); Performance; the “User session” and the Social Event.

Note – in the afternoon there were two “double” sessions. That is there were 2 timeslots where there were double sessions. I had to make a choice – and so wasn’t able to attend CSC’s Integration session, or a presentation on an sucessful upgrade project.

Cloud

“Everyone is doing cloud” and so are CSC.

However in the Life Sciences arena, there is still a lot of hesitation about using the cloud.

Pharma companies operate under the regulatory guidelines (21CFR Part11) of the Food & Drug Administration (FDA), as well as those of other regulatory bodies (European Medicines Agency (EMEA), etc). Remaining compliant is of the utmost importance for these companies. And as with any other industry, the main concerns are to do with: security and availability.

From what I can see, CSC have tried to address these concerns, and offer three IaaS models:

Off Premise

Public Cloud, with all the advantages a public cloud offers – at CSC Data Centers
Private Cloud, to give dedicated access – at CSC Data Centers

On Premise

3. Private Cloud – behind the client’s firewall.

These are all built on Vblocks, a technology that combines VMWare, Cisco and EMC technology, spread across 12 data centers spread across North America, South America, Europe, Asia and Australia.

To address the security concerns, the Security Framework for “CSC Trusted Cloud” is touted as covering a plethora of security points. These fall under the following categories: Access Control, Physical Security, Logical Security (the separation and isolation of client data, etc), and (as option) Data Integrity.

At the same time, compliance to 21CFR Part11 requires three primary components: the Installation Qualification (IQ) – that records contains a complete set of detailed information on the hardware environment, the underlying software (from OS to application) and instructions on how to install the system from out of the box; the Operational Qualification (OQ) – that proves that the system is operating correctly, and the Performance Qualification (PQ) that indicates that the system is performing correctly to meet the stated user requirements.

CSC are planning to use their Cloud model as a basis for delivering their Managed Services solution. The also aim to deliver IQ, and OQ, out-of-the box. This’ll be a great advantage for Pharma companies. They only have to worry about the PQ. This allows the benefits of the cloud to be realised, while remaining compliant.

User Interface Strategy

Currently CSC offers two interfaces for their FirstDoc product.

They makes use of Documentum’s native client – Webtop – and adds their own “compliance logic” to it.
SPX web parts – these are specially developed SharePoint web parts that expose (most of) the FirstDoc functionality, and allow users to interact with documents in a Documentum docbase.

EMC has announced that they will be retiring Webtop. CSC UI strategy addresses this.

xCP

EMC have released xCP (xCelerated Composition Platform). This is a new technology that they have developed that offers for quick application development, through configuration rather than coding. (EMC have written a white paper on xCP that you can download).

EMC released xCP to the world a couple of years ago with much fanfare. At the time they were promoting as a technology for “case management”. Since then, they have changed their message, and now promote xCP to be “the” interface solution.

The current version of xCP is 1.5. EMC will be bringing out version 2.0 which will still focus on Case Based applications, but CSC have been invited to be involved with version 2.1. They plan to assess the gap between FirstDoc requirements and xCP version 2.0 capabilities so that they can contribute suitable requirements.

SPX

CSC plan to continue supporting SPX. SPX stands for SharePoint eXperience and, as mentioned above includes specially designed webparts that can be placed on a SharePoint web site, and allow the users to interact with FirstDocs docbases.

SPX has come a long way since the initial release. CSC’s goal is to close the gap between the functionality available in SPX and that in Webtop. They are not quite there yet, but are getting very close.

While xCP will allow developers to easily create an user interface, SPX has the benefit of being very flexible. The web parts can be dragged easily to different places on the web page, allowing a Portal to be built that matches the way users want to work.

While working on part4 of this series, I noticed a CSC job advertisement for a Senior Product S/W Developer. Looking at the job functions, as well as the qualifications required, it looks like CSC are ramping up their SPX resources.

Performance

As I mentioned in an earlier post (FDUG – Europe – Review of the Agenda), this is one session that I was really looking forward to.

It turned out to be a presentation from one of CSC’s clients, (presented by Bill Meier), outlining what testing that they had done to improve the performance of the FirstDoc system.

This involved some very comprehensive testing. Special environments were set up, and load, and measurement, applications were used to try and determine where the bottlenecks were in the system.

From this came a series of “Corrective Actions”, which were very interesting. I thank the company that provided this information (you know who you are).

User Session

The last session of the day was the User Session. This is where all the CSC staff leave the room, and the users get to really discuss what they find good about CSC, and where CSC could make improvements. This is a half hour event, but it actually went on a lot longer than that.

As always, in the beginning, only one or two compliments, or criticisms are forthcoming, but as always, once the ball starts rolling, the discussion picks up some speed.

During this time, one of the FDUG steering committed (made up of three people from CSC customer base), records the comments.

Normally the next day, the users have a chance to present these to CSC, and give more detail. It’s not a witch hunt, and, I congratulate CSC on giving their clients an opportunity to give them feedback like this. However, the real test is what they do with the feedback…

Social Event

At about 7pm everyone met in the foyer of the hotel. I had a chance to chat with Christoph Langebner, a senior accout executive at CSC. Chris is a very friendly guy, whom I met at last years EMC’s Momentum in Lisbon. Back then he was an expecting father, and a bit nervous about it. Now he’s no longer expecting, and no longer nervous.

The entire troop then marched off to a local restaurant “Huth Gewirtschaft“, which I have read is rate No. 4 out of 1034 restaurants in Vienna. It was a very nice meal, and I found myself sitting opposite Franciska Darmer, a LS Solution Specialist at CSC. (Danish, but living in Florence, Italy – “just for the fun of it”). I was also sitting next to some very interesting people from a couple of different Pharma companies, and at one stage, we all got into an interesting (and friendly) debate over the value of the “electronic signature”. Always interesting to see what other opinions are.

After dinner, the group traipsed off to find a good watering hole. I regret that I didn’t join them…

In Part 4, I’ll discuss the events of the second day.

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FirstDoc User Group – Vienna

Posted on 22/04/2011 by markjowen

I’m going to the FirstDoc User Group (FDUG) conference in Vienna, Europe, this year. (For those that are not familiar with FirstDoc, see the links at the bottom of this post).

Every year CSC hold the FirstDoc User Group conference – first in the US, and then in Europe.

I’m looking forward to it. I’ve been ask to present there so it’s time to put the old thinking cap on, and come up with an interesting way of presenting information. (I don’t want to bore people).

The agenda for the Europe conference hasn’t been posted yet, but the one for the US conference has.

The keynote speech will cover CSC’s Long Term Product Strategy. This will be interesting, as the ECM world is very much a lively, ever-changing thing at the moment, as each large EMC vendor morphs, and adapts to meet the ever-changing environment bought about by such things as SharePoint 2010, and cloud computing.

Next on the schedule is a case study – “Global Deployment”. This will also be interesting as international companies are, and have been for awhile, looking at the challenges of multiple sites, located in disparate locations around the world. The challenges don’t just include the hardware side of distributed systems, but also taxonomies and metadata (ensuring that everyone uses the same vocabulary), etc.

In the afternoon, there will be a panel discussion by representatives of some of the large Pharmaceutical companies on Collaboration, and SPX. SPX is CSC’s technology that allows users to interact with their FirstDoc system from SharePoint. It consists of two parts – SPX web parts, and Wingspan’s DocWay server component that resides on a web service server (see my earlier post for details on this).
I’ve been involved with this technology for the last 4 years, and I am curious what will be covered here.

Later in the day there is also a discussion on FirstDoc Performance metrics.
Now, this is something that I would be very interested in. How do you actually measure the performance of a system, especially when there are so many parts involved? For example, if a user is in SharePoint, and they use SPX to access documents that reside in a Documentum docbase, there is so much going on. If performance is poor, how do you actually pinpoint where the bottleneck is? I know that there are ways to get information back on the activities that occur, but this involves making some changes in the configuration, and is not really a simple thing to do. If I was there, this is one session where I would be scribbling notes. (I know – in these days, I should actually be typing notes into my iPad2).

At the end of the first day there will be a User Only session. In the first FDUG conference 2007, this session caused a little bit of concern. The idea was that the users would have a chance to talk frankly with the users about FirstDoc (at that stage FirstDoc was the name of the company also – it was bought by CSC in 2008.) However, the fact that there was someone from FirstDoc present in the room did not engender a feeling of openness. At later conferences this was less of a problem.

On the second day, there are more strategy, and users sessions culminating in product demonstrations.

Naturally there is also a social event planned, and this really gives the attendees the chance to mix, and get to know the others that are using the CSC products. There is an opportunity to share, and learn, from others who may be dealing with, or have dealt with, similar challenges.

FirstDoc User Groups
CSC
CSC’s acquisition of FirstDoc
FirstDoc (the compliance solution)
SPX
Wingspan Technologies
21CRF Part11

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SharePoint “Upgrades” and discovering a small compatibility issue.

Posted on 01/03/2011 by markjowen

Recently a friend of mine was working on creating a Document Management portal.

That is, he was using SharePoint as the user interface, and was populating the pages with web parts that would allow the user to interact with a back-end document management system.

He had built up the Portal using SharePoint 2007, and had created several sub-sites that contain web parts that were relevant to the requirements of specific groups of users. He had run some informal testing and had confirmed that the web parts were offering the business users the functionality that they required. He had also spent some time on the design of each page. He was using a standard master page so that each sub-site had the same look and feel, but had made small tweaks to each page so that the presentation of the web parts was optimal.

Then he wanted to move the system to a SharePoint 2010 system. Fortunately the Portal site was not yet in use, and nothing extra, or unknown, had been done to the sites, so was pretty sure there wasn’t any customization. However he wasn’t sure what the best way to get his Portal from 2007 to 2010. So he called me.

We had a look at the options:

In-place upgrade,
Database Attach
Build the site from scratch.

SharePoint 2010 had already been installed on a new, suitably spec’d server, so an in-place upgrade was not an option.

We examined the database attach method. This would involve making a backup of the 2007 content database, restoring it in the new SQL Server installation on the the new server, This sounded like a good option. The only thing we were worried about was the third-party we parts (the ones that hooked into the third-part document management system). We weren’t quite sure how these were going to respond.

We considered the third option – building the site from scratch on SP2010. This also introduced new challenges. Could we migrate the default. master from 2007 to 2010? I knew that 2010 didn’t use default.master, but now used v4.master. What impact would that have? We also had the ribbon to contend with, as well as the “Tags & Notes”, and “I like it” buttons. (The sites were meant to be static, offering only the ability of users to work with their documents. It was not meant to be a “social” site.)

One other benefit of an in-place, or database attach upgrade, was the fact that SharePoint 2010 offered a “Visual Upgrade”. That is, the 2007 look and feel is maintained, and there was the ability to “preview” how the sites would look in 2010. Once you were happy with them, you could make the changes permanent.

This would have been nice, but, because of the fact that we wanted to make sure that we could document how the Portal was built up, we decided that option 3 would be the best option.

So – the decision was made. The first step was to install the third-party web parts. And this is where it got interesting. We were using the latest version of these web parts that were SharePoint 2010 compatible, so we thought there would be no problem.

Except there was one small thing…

The third-party web parts were designed to use WSE. WSE, or Web Services Enhancements, is an add-on to the .NET framework that offers improvements to security and communication. It was released in 2005. The SharePoint server had been installed by another department according to a “standard”, and this included WCF, or Windows Communication Foundation. WCF was brought out as the “next-generation web service/interoperability framework”.

So here was the question: Do we get the department that installed the SharePoint server to uninstall WCF, and install WSE? Or do we ask the vendor to test, and certify that their web part technology will work with WCF?

Removing WCF and installing WSE would have very little impact to the overall scheme of things (the server was not being used for anything else), BUT it would mean a non standard installation.

On the other hand, the vendor has stated that their application was compatible with SP2010, and one would assume that it would be designed to use the newer WCF component.

Currently the discussion is going back and forth between the two options.

One thing though, this small compatibility issue wouldn’t have become quite so obvious if we had not decided to build up the Portal from scratch.

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“Selling” something new to the users – a case of how NOT to do it

Posted on 13/12/2010 by markjowen

selling user adoption

Once upon a time, in a far away land, I was present at a demo that a vendor was giving to the end users of a Document Management System. These are users that had worked with the native client (the end-user application) of the DMS for many years. They knew how to make it sing and dance.

The vendor had worked with this customer for many years, and there was a good relationship. The vendor knew how the customer’s business worked. They knew because they were also the vendor of the Document Management System in use, and had originally worked with the customer to set up the system to match the customer’s requirements.

So, there we were. In a conference room. A representative of the vendor stood up front. As well as that there were 4 other people from the vendor in the audience – a technical guy, a subject matter expert, some from the vendor’s product development, and a client manager.

We waited in anticipation. The vendor was going to show us new technology that would allow the user to access the Document Management System via SharePoint using a web part. Not only could we access the documents, we would be able to interact with the document, and attach it workflows, etc. And all this via SharePoint. This had great potential. It meant that we could create “work areas” customised to the users’ requirements. And the specialised web parts could be configured to returns documents that meet specific criteria.

One thing I need to point out is that the users were not familiar with SharePoint, and certainly not with the concept of web parts. This was new technology for them.

The vendor’s representative coughed. Everyone went quite. Then the representative (who required no introduction as everyone had worked with him at one stage, or another) explained that the technical guy had created a working system that he would use to introduce the new technology. He hit a button on his laptop, and the overhead screen in the room flashed to life.

And what did we see. The vendor had created a SharePoint site, and on it were more than 10 web parts. In two columns. Each showing objects from the Document Management System in various forms (one web part showed an inbox showing workflow tasks, another was a single-box search web part, one had an extended search facility showing, one was for browsing a tree structure of folders, others had specific queries behind them.

The vendor carried on talking about what a web part is, and what each web part did, and, the eyes of the users started glazing over. It was too much for them. This was new technology, and a new way of working. What the vendor showed was too much at the same time. The users were confused. And you could tell by the body language that the users were against what the vendor was telling them.

During the presentation, the vendor would be describing a specific web part and the functionality that it provided.

Several of the more entrenched users (those who had been doing their job since day one, and were damned good at it) would make comments like “This is not how we do it.”, or “We do things differently here.”

I cringed as the presentation died a quick death. The vendor had not planned properly for this audience. Even the managers in the audience were confused by what was being shown. After the everyone had left I approached the vendor, and got into a discussion with him about what had happened. After much analysis, the following was agreed:

The vendor hadn’t realized that the technology was so confusing. He works with it every day, and, for him, it was second nature. He had not looked at it from the perspective of his audience.
Too much was presented at the same time. The vendor should have chosen three web parts that provide the base functionality that matched what the users do on a daily basis. Then, once that had been explained, the other web parts could have been introduced.
There was no “education” done first. The vendor could have started with a explanation of what the new technology was and how SharePoint and web parts worked.

These are all basic things. New ways of doing things, new technologies need to be introduced gently. The users need to be held by the hand as they are shown. And then step by step. The more the users feel comfortable with something he easier it is to take them to the next step, and the more open they are to making suggestions of their own. This allows them to think innovatively.

But what had the vendor done? Strapped everyone in to their stools and bombarded their senses with new, and different concepts? And at all at the same time?

What was disappointing was that the vendor was no stranger to the customer. As I mentioned above the customer company and the vendor company had worked together for years. The vendor knew what the users did.They knew what the users knew.

The vendor left promising to do a better job next time. That they would definitely take the softly, softly approach. And because they did have a relationship with the customer, that was OK. However, know they had the extra burden of having to re-convince an already resistant audience.

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The Wingspan Connection – getting SharePoint & Documentum to talk to each other

Posted on 05/11/2010 by markjowen

This is just a short post. Just want to show an overview of how Wingspan components allow a user to access their Documentum documents from SharePoint.

wingspan spx sharepoint documentum firstdoc emc

Taken from Wingspan Documentation

Here you can see that there are two main components:

The DocWay UI is a collection of Web Parts installed on a SharePoint Server .

The DocWay Server comprises two components that are always installed together even though they function independently.

The DocWay Web Service provides Search, Content Management, and Workflow services.
The DocWay Content Transfer Service (DocWay Transfer Service) provides transfer of content between the user’s desktop and individual Documentum Docbases

So, basically, what happens is:

A user logs into their SharePoint site that contains Web Parts supplied by the DocWay UI.
These Web Parts display meta-data gathered by the DocWay Server about content stored in the Documentum Docbases.
Should the user transfer content between their local storage and a Docbase, the transfer is made by the DocWay Transfer Service, bypassing SharePoint entirely.

Included Web Parts for End Users

Home Cabinet
Subscriptions
Checkouts
Recently Accessed Files
Inbox
My Workflows
Virtual Folders
Repository Browser
DQL Query
Object View
Search

Included Web Parts for Administrators

DocWay System Administrator
Menu Designer
Component Administration
Web Part Group Settings

Included Web Parts for Developers

DocWay Diagnostics
AJAX Call Viewer
HTTP Request Inspector
System Information

Wingspan produce several other products that allow integration between Documentum and SharePoint. One of these is eResults that I have posted several times about in this blog (see Tag Cloud).

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Posted on 26/10/2010 by markjowen

I was invited out for dinner after the Welcome Reception by CSC.

CSC offer a product called FirstDoc that adds a compliance layer to Documentum. As well as that, they have products that allows documents in a Documentum repository to be exposed in SharePoint, while maintaining 96% of the functionality of FirstDoc.

It was a very pleasant evening, and the meal that was served was wonderful.

Thanks Nigel, Paul, Chris & Jim.

New EMC Solutions for Healthcare, Life Sciences, and Energy Industries

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FDUG – Europe – I have arrived. (markjowen.com)
FirstDoc User Group 2011 – a look back at the conference – Part 3 (markjowen.com)
FirstDoc User Group 2011 – a look back at the conference – Part 4 (markjowen.com)
FirstDoc User Group 2011 – a lookback at the conference – Part 1 (markjowen.com)
Impact Systems Announces the Release of Two New Content Migration Products for Migrations between EMC Documentum and Microsoft SharePoint (prweb.com)
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Predicting User Acceptance

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