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

Posted on 07/09/2011 by markjowen

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

What the Hell Am I Doing? (or “Should I just...

Realizing True Records Management with Microsoft S...

Day 1 of the AIIM SharePoint Master Class

Europe Momentum 2011 – Resources for those w...

“User Adoption Strategies” – Sec...

SharePoint & Powershell – a great post ...

Productivity, Gamification and SharePoint 2013 ...

FirstDoc User Group 2011 – a look back at th...

SPX Series – A little bit of history

Posted on 01/08/2011 by markjowen

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 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.

Business Data Catalog: Overview
Business Data Catalog: Architecture
Interoperability Scenarios and Technologies for SharePoint Server 2007

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.

http://www.wingspan.com/products/docway-web-parts/

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.

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.

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.

Documentum releases REST resources
7 must known jobs for every Documentum Developer
SPX Series – A little bit of history
FirstDoc User Group – Vienna
SharePoint eXperience – (aka SPX)

The Wingspan Connection – getting SharePoint...

Momentum Lisbon – Welcome Reception.

Tips for creating Great PowerPoint slides

Momentum Lisbon – A welcome invitation.

CMIS – what are the adoption plans for 2011?

FirstDoc User Group 2011 – a look back at th...

Comments on “The Problem with Shared Network...

Productivity, Gamification and SharePoint 2013 ...

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

EMC FirstDoc User Group FDUG

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!

FirstDoc User Group 2011 – a look back at th...

Killa Hertz & The Case of the Missing Documen...

Realizing True Records Management with Microsoft S...

Getting Lost in a Wild SharePoint Site

FirstDoc User Group – Vienna

Killa Hertz & The Case of the Missing Documen...

What the Hell Am I Doing? (or “Should I just...

Killa Hertz & The Case of the Missing Documen...

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.

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