22 November 2011| Article by Thomas Hornbæk Svendsen
Article by Thomas Hornbæk Svendsen, Principal Consultant, NNIT

Document management systems are not a new invention, to say the least. Managing documents has been a necessity for a very long time – and when computers came along, document management systems were quickly presented. The market was available, al-most instantly, and the systems that took over more or less adopted the paradigm defined by paper-based systems, exemplified by the extensive use of what could be termed the “file cabinet metaphor” – a metaphor which still seems to be appropriate today.

Although we might be less dependent upon paper these days, we still rely heavily on its electronic cousin, the trusty old Word document. Many documents never leave the hard disk to materialise into a cellulose-based form, and yet we carry on with margins, paragraphs, headers and footers, and page numbers. All evidence points to our perception of a document as something that emerges as an A4 or letter-based counterpart of the image displayed on the computer

Documents anywhere, anytime and on any device
The conclusion is that we still need document management systems to assist us, and as a future discipline as well. However, what should such systems look like if they need to make documents readily available anywhere, anytime and on any device? What if document creators, reviewers, approvers and readers expect access from occasionally connected, portable devices like smart phones and tablet computers? What if users of document management systems refuse to be limited to carrying out their work from a company-controlled computer? That type of user behaviour is what is behind the term “mobility” – and it constitutes a severe impact on the entire infrastructure behind a document management system. It will impact your strategy, it will impact your processes, it will impact the way you integrate systems and it will force you to reconsider security aspects. Thus, the paradigm shift is not so much in how we perceive documents – what they actually look like – but much more in how they are handled. Or should we rephrase that to from where they are handled?

It is important to recognise that mobility is not so much about technology – it is a state of mind. Today, users already expect information to be readily available, regardless of time and place. They do not perceive e-mails, social networks and information as items that are tied to certain locations or only available within a certain context; they expect it to be omnipresent.

As you read these paragraphs, people are reaching out to family, friends and colleagues using mobile devices within their private sphere. Do not expect the same people to un-derstand why this cannot be the case when using the company’s IT systems. They will probably expect to be able to use their personal mobile devices at work, with huge impli-cations for your IT infrastructure and the way you do business. This tendency has been coined as “consumerisation” and deals with the trend that for many users there is a blurry line between the private and professional spheres. Users want to use their own smart phones and tablet computers for both leisure and work; in mobility terms, they want support for BYOD (Bring Your Own Device), or even support for BYOA (Bring Your Own Application). And, they do not want to have to bother about access restrictions, firewalls or when which device can be used for what. Your users want transparent access around the clock.

Collaboration does not necessarily mean mobility
For document management systems, this means that you must rethink how documents are created and shared among different types of users. We are leaving a world behind where SharePoint-enabled access was enough to support collaboration. Mobility goes far beyond that, making documents much more widely available. One challenge is that Commercial Off The Shelf (COTS) document management systems are nowhere near supporting that scenario today. The vendors will tell you that they have collaborative editions available – and that might be true. But they do not have systems in production that will help you integrate systems and infrastructure in a way that truly supports mobility. Editions providing true support for mobility will eventually become available – so look out for those releases if you want to avoid ending up with a dinosaur system, just waiting for a meteor with its name on it.

Compliance on the road
For regulatory document management systems support for electronic records according to FDA’s CFR 21 Part 11, for example, is essential. Traditionally, this has been accomplished by implementing proper electronic controls that enable you to maintain a persuasive audit trail and trustworthy electronic signatures that users are obliged to use.
This is relatively easy to implement in a traditional IT system that tightly integrates with an identity management system (often this is a standard feature). But it becomes more complex when a user wants to issue an electronic signature using a mobile device that is not necessarily online with your company’s identity management system. Or, when an electronic signature must be issued from a device that is not controlled by you, but by a Clinical Research Organisation (CRO), for instance, that uses their own smart phones or tablet computers. In such cases you must be able to provide audit trail capabilities and support use of electronic signatures on devices of which you know little, or perhaps nothing.
The same challenges arise if you want to channel highly confidential data from third party mobile devices to a clinical data warehouse or an electronic submission system. Mobility will mean less control with the devices used for interacting with your data compared to more traditional solutions controlled by your organisation. The ability to maintain a complete and accurate audit trail will constitute a challenge when systems become mobility-enabled.
In constellations like this, it is critical that the focus is on protecting data, more than the device. Data is still your most critical asset. This is important to remember when Line of Business wants to be able to access and manipulate data and documents from apps, even if your IT infrastructure is not ready for it.

Coordination and orchestration
To prepare your document management system to the mobility era you need (besides defining the strategy of its use) to turn your attention to the engine room. You need to ensure that the IT infrastructure is able to deliver high-quality data and information through customer-facing portals and internal work-optimising applications. Your IT infra-structure is a key factor to your success, so it should not be neglected. Maintenance and development of the IT infrastructure must be coordinated and orchestrated with your strategic visions as well with your plans for the existing and future application portfolio.
Mobility is a paradigm-shift and definitely a challenge. But it will, eventually, constitute a prerequisite for working together with your employees, business partners and customers, and the process of working with documents collaboratively as well. Adopted wisely, it has the potential to let you experience profits above the norm, achieve significant cost reduc-tions and engage in productive and long-lasting relations with key stakeholders.