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

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.

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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.

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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!