Total Regulatory Solution – a “complete” offering from CSC – Webinar 1

The other day I received an invitation from CSC to attend a series of three webinars on their “Total Regulatory Solution” offering.

The “Total Regulatory Solution” consists of three “components”:

  • Software
  • As a service offering
  • Business Process Outsourcing.

Having described CSC’s plans for this earlier (In Part 1, and Part 2 of the FirstDoc User Group posts), I was curious to see what CSC would cover.

Webinar 1

The first webinar was entitled “Flicking the Switch: Integration Drives Greater Regulatory Efficiency” and was presented by Jennifer Webstrom. 

Here are some key points from the webinar:

  • CSC’s was primarily driven by technology (that is – what is required to make sure that their products would run on the latest, and upcoming, technology platforms).
    Approximately 18 months ago they decided to change to focus more on how they can solve business problems that their customers were having.
  • They want to be the go-to company for regulatory submissions.
    Or, to quote their mission statement, they want to…

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

  • With the recent acquisition of ISI, CSC offer tools that allow for end-to-end regulatory information management process. These include:
    • Tracker  
    • Assembly Planner
    • FirstDoc or FirstPoint
    • eCDTXPress
    • Publisher
    • Viewer
  • These applications are, currently, disparate applications, but CSC are working to integrate these tools so that they share a common data model, have the same interface, and (ultimately) will be “aware” of the other tools, in the sense that operations in one tool trigger certain “pre-emptive” actions in the other tools.
  • The integration roadmap includes the following:
    • ensure that Publisher, eCDTXpress, FirstDoc, and Viewer work together
    • release of Tracker – integrated with Viewer
    • release of Assembly Planner – integrated with Tracker

Strategy Analysis

This had to happen. Providing an application, or a collection applications, that allow users to perform specific tasks is one thing, but to have a truly integrated suite of tools that can work together, is another. Users do not want to have to “think” about what they are doing. They just want to be able to complete a task, in the most efficient way they can, without having to consider the different interfaces that they need to work with, or the different processes that they have to follow for each application they use.

By changing their focus from one of technology to one that is more on the business challenges that pharmaceuticals companies face, means that CSC can streamline the whole regulatory submission process so that there is as little “pain” as possible.

And, naturally, if they can achieve this, they do help to position themselves in the market as the “one-stop shop” that they want to be.

The other webinars

As mentioned above, there are three webinars in which CSC are describing their new “Total Regulatory Solution”. The other webinars are:

  • Data in the Sky: Finding Flexible Solutions in the Cloud
  • Clearing the Path to Innovation: Exploring Total Regulatory Outsourcing

I plan to write posts on these as well.

Reference sites

How does FirstDoc “do” 21 CFR Part 11 compliance?

21_CFR_Part_11_compliant

CSC have published (not recently) a whitepaper about the capabilities that FirstDoc products provide for compliance with the FDA’s ruling on Electronic Records and Electronic Signatures (fondly known in the Pharma industry as “21 CFR Part 11″).

The whitepaper is a good one. It starts off with a recap of what is contained in 21 CFR Part 11, and then does an itemised breakdown of the capabilities that the FirstDoc products have to meet the compliance requirements.

You can download it here.

21 CFR Part 11 Compliance Position for FirstDoc Applications

Related Post: FirstDoc, FirstPoint, NextDocs – a “rough notes” comparison

SPX Series – A little bit of history

This is part of the SPX Series

Previous post: SPX Series – SharePoint eXperience – (aka SPX) – Series Introduction

First off – I want to explain that I am, in no shape or form, an SPX “expert”. I’m just a guy who has been using SPX since it was first released. I’m not a coder, so can’t tell you all the cool ways that the web parts can be tweaked, or made to dance. I am able to share with you the some of the “lessons learned”, and tips . that I have picked up over time. Some of what I write might be incorrect. Please feel free to let me know if that is the case.

And, where possible, if there are other resources that explain something better than I can, I’ll point you to it.

So without further delay I will launch into today’s SPX post…”A little bit of history“.

SharePoint

In 2007 Microsoft introduced SharePoint 2007.

As well as providing the ability to store content in its own repositories (doclibs, lists), it also provided web sites that could be populated with web parts that allowed users to interact with internal content (lists and SharePoint repositories), as well as external content. This included other LOB enterprise systems (such as SAP, Siebel, etc). There was no native way to connect SharePoint and Documentum though.

Wingspan

A company called Wingspan had also developed technology that provided Web Services connectivity to Documentum.  This consists of the Docway Server, and Docway “Portlets”, (and for SharePoint – Webparts), and allowed for single sign-on,  cross-docbase browsing, as well as the ability for users to access, create & update content from a Portal.

SPX

CSC’s FirstDoc, provides a layer that sits on top of Documentum, and allows for compliance with many of the Pharmaceutical regulatory requirements imposed by the various regulatory authorities (FDA, EMA,  MHRA, etc.)

Using Wingspans technology, CSC (or, at the time, FCG), were able to create special webparts that allowed users to interact with their FirstDoc system from a SharePoint Portal. These offered about 85% percent of the functionality provided by the native FirstDoc application.

4.3

The first version was released in the 2nd half of 2007, and had the moniker “version 4.3“. This was to keep the version inline with the (then current) version of FirstDoc. It was compatiable with version 5.3 of Documentum.

There were 17 webparts available. These included webparts for browsing cabinets, listing the logged-on users checked-out documents, displaying the Home Cabinet, an inbox webpart, an very handy object-view webpart that could be configured to display one particular folder, or cabinet), an also handy query-view webpart that allowed content to be displayed based on a query, as well as an assortment of other functional webparts, and administration webparts.

Each web part offered a user the ability to further interact with an object via a context menu that showed extra functionality depending on the type of object that was clicked upon.

Courtesy of CSC

This first version was an excellent step towards greater flexibility in creating interfaces for users that better matched their daily work style. For the 80% of users who rarely log into FirstDoc, it provided a quick and easy way to get to specific documents. Links to specific documents could be sent via e-mail, and when a user clicked on it, the document would automatically be opened, without having to go through a process of logging into a client and searching for a document.

But there were also several shortcomings. There was the 20% of hard-core users that quickly discovered that there was still a lot of functionality that was not available. Also the SPX interface did not offer the same flexibility that WebTop did. You couldn’t easily change the columns that you wanted displayed, the search functionality when compared to the WebTop search was very limited, and the way of interacting with the documents was different. The context menu was not found in WebTop.  Performance was also a bit sluggish especially when using the webparts over a WAN.

To be fair, CSC were also restrained by the limitations of the underlying Docway technology.
(However, Wingspan have been making continual improvements to their technology and CSC have been able to take advantage of this).

5.0

CSC listened to the concerns that the hard core users (as well as the administrators) were having. Version 5.0 of SPX was released in the middle of 2008, with Product Alias Search functionality, the ability to limit search results, and also the ability to add multiple documents to a workflow. Version 5.0 was also compatible with Documentum 6.0

6.0

Then later that year, version 6.0 was released. This was based on Documentum 6.5, and an upgraded version of Docway(6.1). It had been designed to be backwards compatible (with configuration, it could work with version 4.3 of FirstDoc). This allowed SPX to work over multiple docbases of different versions. As well as this, the Inbox and Query webparts were tweaked so that values could be automatically passed on the URL. Menu selection was made configurable. A quicklink capability was added that allows a link to be configured that will launch FirstDoc functionality, and the ability to View Relationships, and Audit Trail reports was added.

6.1

Then, in the later part of 2009, version 6.1 was released with even more functionality – Virtual Documents could now be viewed, multiple files could be imported, a new :”My Views” webpart was available, as well as the ability to view the Workflow Status report. Importing related documents was now, also possible. A version 6.1.1. was also released but this was a correction to a limitation that was previously believed to be uncorrectable.

Courtesy of CSC

6.2

In 2010, version 6.2 and 6.2.1 were released. The only difference was that 6.2.1 was certified for use with SharePoint 2010. Both versions also used Docway 7.0.  And there was a bundle of new features and functionality. These included: the ability to register interest, the availability of the WebTop Search app as a webpart, a single-box search (“Google-like”), Saved Searches, the ability to display custom properties in the web parts, clipboard tools, subscription notifications, as well as other functionality.

Future

CSC are working on the next release of  SPX, and it looks like they’ll be adding even more functionality to close the gap between SPX and WebTop.

FirstDoc doesn’t have its own client application – it extends the functionality of the EMC Documentum native client – “WebTop”. EMC has announced that they will be phasing out this out sometime soon.  As a result CSC are dedicated to ensuring that SPX is ready to be a replacement.

So – that’s the end of my “A little bit of history” post. If have made mistakes anywhere, please feel free to let me know.