Industries 2018-09-05T07:04:49+00:00

About

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The Life Science industry’s pursuit for new cures requires a lot of investment, both in terms of research and money. They also have to deal with every changing regulations and living up to quality standards. This also takes up a considerable amount of the available budget. Needless to say: spending money wisely is key.

Reducing cost can be done in many ways, but the Life Science industry – represented by the Drug Information Association – choose to develop standards for non-competitive business processes. The management of documentation is one of the processes. Being a start-up or a billion-dollar enterprises, they all face the same rules and regulations regarding documenting research, trials and submissions. In 2009 the DIA agreed to develop a flexible, open, free and sustainable model for the entire industry. This resulted in the EDM and eTMF Reference Models.

Ever since the birth of Documentum, they have a leading role in the Life Science industry. Today their OpenText Documentum for Life Sciences platform provide the industry with the best of document management based on the DIA reference models. A preconfigured solution that not only includes the model but also the approval processes and training features.

At Informed Consulting, we not only know this set of solutions inside-out, we have complemented it by developing our own products:

  • SPA4LS is a SharePoint add-on to support e.g. Partner Exchange and eTMF content transfers.
  • EQMS Express is a Quality Management Solution, targeted at those organizations that do not need all the extended features that large enterprises need.
  • DOLSR is our GxP compliant private-cloud solution that is pre-configured to meet the needs of a CRO, CMO, start-up or even a full-cycle Life Science organisation. It enhances the Documentum for Life Sciences platform with optional modules like EQMS Express, Extedo’s Submission Manager and LMS365.

As an organisation we are also applying the Life Science best practices to our own organisation. We apply GAMP 5 compliance to our own product development and use DIA education to provide our consultants with the required domain skills.

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Governmental organizations are rapidly moving towards new ways of working to better support their processes and service their customers. To create a smooth process, employees need to be able to rapidly adopt to changes. Case Management supports this new working methods.

Be it building permits, public participation, social benefits or other topics, when it comes to rapid and effective solutions to facilitate this new way of working, Documentum xCP is a key component. It is a great example of a composition platform that excels in combining configurable solutions where almost no code is used, with superb user experience possibilities.

Informed Consulting has delivered multiple significant solutions based upon the Documentum xCP product. During these projects we have been able to educate many on the need for a solution that allows composition: custom through configuration. Each government body differs in culture, staffing, processes, maturity, ambition and budget. There is no ‘one-size fits all’, even if the case-type is the same. After the initial implementation, the business process isn’t set in stone. It is constantly changing. Managing change is an inherent part of our approach and our design.

At Informed Consulting, we not only master the skills to configure these xCP-based solutions but are also highly competent in the most important aspect: User Experience (UX). Especially in Government, the need for first class change management is a must have. Our UX experts help organizations take that hurdle during the beginning of the project. Long before the xCP-based solution is configured, the future users learn how it will behave and can be trained in using and spotting flaws in the solution.

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In this multidisciplinary industry, it is key to ensure control and accessibility of the as-built information as well as the Standard Operating Procedures (SOPs). Timely and secure access to project content and fast, effective collaboration across virtual project teams is important. You also want your global network of suppliers, vendors and partners to be up to date and deliver on time.

It is of utmost importance that all stakeholders have access to a single source of the truth and have access to information they need anytime, anywhere.

At Informed Consulting, we know that this business challenge can be solved easily with the vertical solutions that are available on the Documentum platform. Solutions that leverage the powers of the platform and are preconfigured with the industry best practices. Those solutions include Asset Operations, Capital Projects, Handover and Commissioning and Supplier Exchange.