Monthly Archives: June 2011

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

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Previous Post: FirstDoc User Group 2011 – a look back at the conference – Part 1

In Part 1 of the FDUG 2011 series, I described the location of the meeting, and gave an overview of CSC’s plan and strategies. In Part 2, I’ll talk about the rest of the conference.

Going thin

After the break, two of the Pharma companies gave a presentation on a project that they were each involved with to upgrade their document management system.

I’m not at liberty to discuss the details, but it is obvious that the drivers in the pharmaceutical world are the same as in any other business. Namely,

  • Try and get as much functionality out of a product without writing customized code.
  • Aim to increase the useability of a solution
  • Make use of “thin” technology – (Portals).

The business cases presented described how CSC technology was being used to allow these goals to be met.  Always interesting to see, as this is a common theme.

Partnership Program

In the session  CSC described their “Partner Program” plans.

CSC’s goal here is to “put more effort into Partnerships to increase their usefulness.”  That is, with a good network of “CSC Partners”, CSC can meet client requirements, be able to offer more, and be more responsive (i.e. have more resources available) .

Companies that partner with CSC will fall into of three areas: Technology; Sales; Solution. Each area has its own “model” and KPIs that need to be met to be able to retain their status. “Customer Satisfaction” being the most important.

The message was that CSC want to seriously lift their game here. This will include certification, KPIs, working with the Partners to bring over a “unified” message.

Certification

As mentioned, CSC will be offering a certification program.

This will be made up of 4-tiered capabilities (Installation, Configuration, Customization, and Architecture). CSC are looking at some type of “boot camp” experience where individuals attend a week long course for each capability. This will be followed by several weeks of “shadowing” on client projects.

The fact that CSC mention this, signals that they want to set a standard that people that partner with them will meet. Which is encouraging. The “certification” is for the individual (that is, it’s not transferable to other people at the Partnersite).

Curious to see how this one will pan out.

Total Regulatory Solution

In the keynote presentation, there was mention of CSC’s “Total Regulatory Solution”.

Jennifer Wemstrom (who flew over to this year’s European FDUG) presented CSC’s overview of their “Total Regulatory Solution”.

Underpinning this is CSC’s aim to provide the “Total Business Solution” that supports the creation, management and consumption of regulatory documentation in the Life Sciences industry.

In simple words, CSC have got all the tools (especially since their acquisition of ISI and their Publishing tools) to achieve this, but the tools are still disparate applications. CSC’s goal is that all these disparate systems will be unified. They will have a common interface, and a use a shared data model.

This is definitely the right move. In my years as a ECM specialist I have seen companies grow through the acquisition of other companies that offer a solution that compliments, or even enhances, the parent companies offerings. The next logical step is to integrate the applications that make up the suite so that the user is presented with a seamless “solution”.

At the same time CSC seem to be actively investigating offering more than just a suite of technical products. They have realised that they have a lot of skill and knowledge in this area, and are talking about Business Process Outsourcing, and offering their Total Regulatory Solution as a managed service. (This ties in with CSC’s goal to dive into the cloud.)

New Product Offerings

CSC realise that there are still a few “gaps” in their offering. They are busy with  three new products. These are all to do with the submission end of the process. It looks like CSC are really listening to their customers.

Business Process Outsourcing

In this area CSC have three offerings:

  • Staff Augmentation – where CSC staff will work “side by side” with the customer;
  • Tactical Outsourcing – where CSC will handle specific aspects of the regulatory process.
  • Functional Outsourcing of regulatory activity.

As mentioned above, CSC definitely want to make good use of the skills & experience they have built up, and want to expand into offering services rather than just technology.

To back this up, CSC described how they will be tackling staff training (resource development). They have three levels which includes a sort of “orientation/induction” level, “core training” for regulatory activities, and then, “client specific training” which addresses the activities that a client has outsourced to CSC.

Managed Services

CSC have a series of Managed Service Models. These include the traditional models of “on premise” or “hosted” through to “As a service” which includes “Dedicated”, “Private Cloud”, and “Public Cloud”.  A flavor to suit all requirements.

FirstDocs 6.3

Bill Meier spent some time discussing the CSC’s latest version of FirstDoc (version 6.3) which include a large number of enhancements.

A few of the high points include the fact that this version will be certified on Linux.

…continued in Part 3

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

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Working with Global Teams: e-mail confirmation

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land_of_confusion_2-wallpaper-960x600
This is part of the Working with Global Teams series

A global team, by its very definition, is made of of people in different geographical locations and often different time zones.

In these situations, it is a good idea, if you receive an e-mail from one of the other team members, some sort of sign, or acknowledgement that you have read the e-mail. Sure, you can set up email to notify the sender when the recipient has opened the email, but nothing is as good as clicking on Reply, and typing a quick e-mail to say “Hey – just looking into“, or “Got your e-mail. Just need to talk to Fred & Tish about it“.

When people are not able to stroll into the other person’s office, or peer over their cubicle divider, this small “communication” just let’s those people involved know what is going on.

Even then – it doesn’t have to be a reply by e-mail. Could be an IM, or even (gasp) a phone call. The benefit of an e-mail response includes:

  • Usually the reply will include the original e-mail. You get conversation chain.
  • If the person you sent the email to is not in a different time zone, it doesn’t matter if the person isn’t online at the time.

This way the sender at least knows whether that something is happening. This leads to a better “team”.

email communication responding polite global

Following Post: Pesky Time Zones

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Using a network file share – a case study

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Storage folders

Image via Wikipedia

This post continues from the previous one where I debated some of the draw-backs of using a network file share.

In that last post I mentioned there are some situations where using a file share can still be useful.

Case Study

Company A has been storing content on a file share for many, many years. People have the been granted access to specific folders, and they also have the freedom of creating sub-folders (which they do).

Over time, the file share becomes unmanageable. As Adrian pointed out in his post, this has several disadvantages: nothing can be easily found; a lot of the information ins inaccessible; collaboration is not as effective as it could be, etc.

Recently Company A became aware of SharePoint. “Cool!” they thought, let’s move everything into a document library. Then we won’t have problems any more.

Is SharePoint the answer?

I certainly agree that a product like SharePoint can be useful. Once the content is in SharePoint, it can be further categorized using metadata, made accessible through the use of views, etc, and can be easily searched. Company A also thought this way.

Company A considered a couple of options here:

  1. Move the content from the file share to a SharePoint document library, and then just get SharePoint to index it, so that a search can be done whenever anyone needs to find something.
  2. Move the content from the file share to the document library, and then add appropriate metadata (enrich), and then also perform a crawl.

Let’s look at the options

Both option 1 and 2 are good options. Having all the content in SharePoint means that it’s all there in one place. Security can be applied, as well as versioning.

Option 2 increases the findability of the content even more by adding rich, meaningful metadata. Company A can create a taxonomy that allows the content to be suitably categorised. Combined with customizable views, users can display the content of the document libraries in multiple different ways.

Disadvantages–
  • As mentioned, there are terabytes of content in the fileshares.
    Moving terabytes of content into a document library would mean that the database is now terabytes in size.  Unless the data is properly optimized, and maintained, this will be a big hit on performance.
  • In the fileshares there are thousands of text documents, spreadsheets, pdfs, images, CAD drawings, project files, mp3 files, films, executables, and a wide assortment of different file formats, from the different applications.
    SharePoint can accept all these formats, but, by default, a lot of these file formats are excluded from being placed in a document library, and exceptions have to be made.

Alternatives

The file share has worked well for a long time. The main concerns were:

a. manageability – it was hard to manage security to the fileshares, as well as keeping track of when files were modified. It was also extremely difficult to navigate the folder structure; and

b. findability – It was almost impossible to locate any files (unless you knew where they were in the first place.

Keeping this in mind, here are a couple of alternatives Company A could consider:

  1. Keep everything in the fileshare, but configure SharePoint to crawl, and index the files in it.
  2. Keep “static” files  in the fileshare, move “dynamic” ones into SharePoint.

Let’s look at the alternatives

Alternative 1

The advantages of the first scenario is that you avoid that very, very large database. By setting up the fileshare as a content source, you can configure SharePoint to crawl it. And, as a result users can perform searches to find what they want. Scheduling incremental crawls allows SharePoint to pick up any changes that are made to the content of the files.

The disadvantage of this becomes obvious when the security changes on the file. A full crawl is necessary to pick up any security changes. This means that if there are regular security changes (new users being granted access to the share, access to documents being changed, etc) a full crawl is required. This can take a very long time (especially with a slow/busy network).

Alternative 2.

In this second scenario, a little bit of work is required to identify all the documents that are not  “active” documents (i.e. the documents that users are not currently modifying). This would include films, images, executables, and any files taht are not “dynamic”.

Then the company could move any documents that are “dynamic” (still being edited, etc) into SharePoint. Then, as described above, extra metadata can be added to improve findability.

The fileshare can then be treated as an “archive”, and the security changed to be Read Only. This will ensure that no documents get modified. And therefore the content only has to be crawl once.

Alternatively, lock down the file share so that no one can modify the permissions on folders or documents. Because there is no security change, no full crawl is required. Regular incremental crawls can be scheduled to pick up an changes to the content of the document.

Another alternative

The other day I was watching a demo of AvePoint’s File Share Connector. This connector allowed users working in SharePoint to interact seamlessly with the documents that were actually in the file share.

The obvious advantage of this is that SharePoint functionality is available, without jamming all the files in the database.

I was pretty impressed with what I saw. However – I haven’t used the connector myself, in a real-live situation, so I cannot make any comments on it.  If you have used it, please feel free to let me know.

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FirstDoc User Group 2011 – a look back at the conference – Part 1

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Previous Post: FDUG – Europe – Review of the Agenda

In this post I discuss the recently held 2011 FirstDoc User Group conference. Because there was so much content I am doing this in multiple posts.

Location and Venue

As described in my earlier post, this year’s FDUG was held in Vienna. At the end of each FDUG Conference , the organizers ask the attendees where they would like the next one to be held. Vienna came up on the list two years ago as a favourite, and clearly made its way to the top of the list. Not a bad choice.

The conference was held at the Marriott Hotel. The conference rooms were great, and the catering was superb. The breakfast available at the beginning of each day was an excellent idea!

Attendees

Pharma Customers

There was a lot of people at this years user group. There were 53 attendees, representing 21 of CSC’s 47 Pharma customers.

CSC Team

  • Marty Magazzolo – Global Practice Director, ECCM Life Sciences
  • Paul Attridge – Head of Life Sciences ECCM Product Development
  • Jennifer Wemstrom – Director, Regulatory Solutions
  • Bill Meier – FirstDoc Product Manager
  • Franciska Darmer – Life Sciences Solution Specialist
  • Christopher Langebner – Senior Account Executive
  • Steve Scrace – Senior Account Executive
  • Pablo Santiago – Manager, CSC Spain
  • Rober Svanetti – Life Sciences Manager, CSC Italy
  • Tobia Griessel – Account Executive, CSC Germany

Sessions

In my last FDUG post I talked about the proposed agenda. Fortunately there weren’t many changes.

You can view the agenda here.

KeyNote & Strategy Update

After a warm welcome by Bill Meier,  the Conference kicked off with the KeyNote.

Marty Magazzolo, the Global Practice Director, took to the stage and gave an update on CSC’s strategy, as well as describing a little bit of the original goal of their purchase of FCG. Namely, it was to “be more inline with their customers’ business needs than rather being a pure IT vendor” (Even though in quotes, the previous statement is, most likely not exact, but gets the same message across.)

Business – CSC nows considers itself a “Global Technology and Business Services Company”, and operates in three lines of business:

  • Business Solutions & Services
  • Managed Services Sector
  • North American Public Sector

Software Strategy – With it’s recent acquisition of ISI, CSC now has a range of products that allow it to offer “Total Business Solutions”.

In fact their Mission Statement is:

Provide end to end business solutions for processes involving the creation, review, approval, consumption & exchange of regulated and mission critical documents and content within a Life Sciences organization

To achieve this, CSC have created several “Total” solutions – These include one for Regulatory, one for Clinical, and one for Quality. These played a large role in this year’s conference.

At the same time, CSC admitted that the solutions are still made up of disparate systems. The goals for the future are to streamline them so that they use a common interface, a common database structure, and work together seamlessly.

Business Process Outsourcing – CSC feel that they can offer the expertise necessary to handle customer’s regulatory, and other, requirements. A benefit of this outsourcing model is that “skills are sharpened and rotated” allowing their (CSC’s) staff to gain skills in a wide area, and these resources can then be called upon, when necessary, for specific tasks. The cost savings, CSC claim, are seen when you compare to having specialist skills in-house full-time.

Cloud – Paul Attridge said “Everyone’s got a cloud”, and  CSC are also “clouding up” and are looking at offering both private and public cloud service models.

System Integration – CSC’s message was that they intend to create better integration with other products. The goal is to be able to offer solutions to their customers that match the “real world” situation. Even if the solution requires integrating with other ECM related products (and is achieved through partnerships).

CSC are also trying to keeping an eye on the progress of the SAFE-BioPharma® Digital Identity and Signature Standard, to determine whether they will need to offer suitable integration capabilities.

User Interface – CSC add FirstDoc functionality to EMC’s “fat” client for Documentum – WebTop. EMC have announced WebTop is being phased out after Version 7 of Documentum. CSC are working to ensure that their SharePoint web part technology (SPX) will have the same features as offered by WebTop.  At the same time CSC will be investing in creating an interface using EMC’s  rapid application development technology, xCP.  (In fact, EMC have asked CSC to help ensure that version 2.1 of xCP will provide complete content management capabilities.)

This brought us to the end of the Keynote and Strategy session. Before the coffee break Bill Meier shared with us an interesting article he had read over  the effects of coffee – caffeine increase alertness in woman, but, in men, there is a drop in performance and confidence. (This link describes a little of what Bill was talking about).

I will cover the other sessions in a later post.

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

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Tips for creating Great PowerPoint slides

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When I was at the European SharePoint Best Practices conference in London this year, I had the pleasure of meeting Ruven Gotz.

Ruven is a is a Senior Consultant & SharePoint MVP with Navantis, and gave an excellent presentation on “How to organise effective requirements gathering workshops“.

The subject was interesting, but what I was really impressed with, was the style of Ruven’s PowerPoint slides. They made me listen to what Ruven had to say (rather than switch off and just read what was on the screen).

Ruven’s style impressed me so much that I tried to emulate it recently. It wasn’t such a success.

Thankfully Ruven has just written a post on creating excellent powerpoint presentations.I strongly reccommend that you go to his site and have a read.

Ruven’s post: Can you read that at the back of the room?

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Will IT actually help? – A response to Dux

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2015: Note: the piece that Dux originally wrote (and to which this post is a response to) doesn’t exist any more. I am unable to find it anywhere on the internet (even WayBackMachine doesn’t have a copy)…

In a  recent post, Dux Raymond Sy (@MeetDux) discussed that with the increased use of SharePoint by the “Business” (i.e. Business user identifying value in having a SharePoint site/portal), the traditional IT support department’s role will change.

He believes that the IT department’s role will become more “consultative”, and work with the business to build solutions, rather than just offering typical “typical break-fix (and install – MjO) assistance”

Dux is someone that I respect. I have attended some of his webinars and have read (OK – I’m reading) his SharePoint for Project Management book.  He really knows his stuff.

Even though what he describes sounds logical,  I don’t think that it will happen.

To really supply a “solution” you really have to understand the business. The traditional IT department contains people who understand technology. And that’s very valuable.

However, to really understand “the business” requires working in “the business”. And even then each business “entity” (department, group, division) has its own business processes. To really understand these processes takes time. It requires talking with representatives from “the business”.

And this takes time. And there will still be many urgent things that need getting fixed, installed, maintained, backed up, restored, etc.

I am of the (humble) opinion that there is still a need for another layer (albeit, a thin one) between “the business” and “IT”. This is a layer that is able to spend that time with the business to understand their requirements, and to build the solutions. And to work with “IT” to ensure that the infrastructure for doing this is available.

Dux’s Post: How do you see IT Orgs role changing as SharePoint is becoming a business enablement platform?

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FDUG – Europe – Review of the Agenda

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Previous post: FirstDoc User Group – Vienna

I’ve just arrived at my hotel in Vienna and after kicking off my shoes, and scouring the room for free stuff, I decided to see if there are any updates on the 2011 Europe FirstDoc User Conference.

What’s Planned?

Checking out the CSC page lead me to the FDUG Agenda. It looks like it’s going to be an interesting time with a mixture of Strategy announcements and product discussion by CSC, along with several presentations by several Pharma companies.

The Agenda can easily be viewed on the CSC web site, so I won’t be encroaching any secrecy oath that I may have taken when after hours of grueling initiation into the Regulatory world.

First thing that is noticeable is that the US FirstDoc User Group, recently held in Las Vegas, started half an hour later than the one in Europe. Maybe that says something, maybe not – just mentioning it…

Boehringer Ingelheim, and Bayer will both be presenting a Case study on Global Deployment. This looks interesting. They presented the same thing at the US FDUG, and I think it might be of real value, especially with the expansion of a lot of pharma companies into global operations.

After the lunch break, CSC will be discussing their upcoming versions, as well as discussing a “Total Regulatory Solution”. In the US this was presented by Jennifer Wemstrom, who is the Head of Product Stratergy at CSC. I’m not sure who will be presenting at the Europe conference. In any case – I’m am curious what CSC’s “total regulatory solution” will look like.

In Las Vegas, there was a panel discussion by several Pharma companies regarding “Collaboration and SPX Deployment”. From the Las Vegas agenda I see that Abbott, Amgen and Allergen all participated in this, but from what I have heard, it was a very popular subject, and a lot of other conference participants were also involved. The same “topic” will be addressed at the Vienna conference, and I will be involved with this session.

One thing that they had in Las Vegas, (and which I referred to in an earlier post) is a session on FirstDoc Performance Metrics. In the Vienna agenda the afternoon sessions are split into two streams, and one of these will be on “Performance”. I hope that this will be the same.

In the US, Amgen also presented a session on “Training Strategies”, which is not on the Europe schedule.

On the 2nd day, the are several customer presentations: Abbott will be discussing SPX, and Amgen will be discussing eTMF (electronic Trial Master File). Arcondis will be doing a session later in the day on Validation.

One thing that CSC presented in the US, and will be presenting in Vienna, is on “Total Clinical Solution”. Once again, I’m curious what this will be.

And another thing that CSC presented on in Las Vegas is their “Trusted Cloud Solution”. Which makes sense, I guess, because EMC are promoting their “cloudiness” at lot these days (from what I read on the tweets, and blogs that were written during, and after the recent EMC World/Momentum). The FirstDoc solution is designed to provide the “regulatory logical layer” to Documentum. CSC also have FirstPoint – the same thing, but for SharePoint. Microsoft are also busy putting SharePoint in the cloud (and have done so recently with Office365).

I know that the Pharma world is very “compliance sensitive”, and I’m really looking forward to seeing how CSC intend to address any security concerns, as well as compliance issue. Unfortunately, this does not seem to be mentioned in the Agenda for the Vienna conference. However, I’m going to do some research, and will write a future blog post on this.

Conference sessions

I won’t be blogging “live” from the conference, and I haven’t seen any mention of a hashtag for the FDUG. However I hope to write some review posts, either at the end of each day, or after the conference has finished.

At the same time, I want to see some of the sights in Vienna. the FDUG conferences always have a great social event, and this also gives a great opportunity to see something of the surroundings.

Next Post: FirstDoc User Group 2011 – a look back at the conference – Part 1

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