Archive for the ‘Life Sciences’ Category

Regulatory Information Management – Where Are You on the Journey?

Life Sciences companies are under pressure to reduce the costs of regulatory operations and speed up health agency approval to accelerate time to market. However, this is no easy task!


Each organization is in a unique place on the Regulatory Information Management (RIM) continuum – some need to put a foundational content management system in place, others are trying to unify processes with affiliates or shrink their dependency on spreadsheets and yet, others are trying to rationalize myriad and duplicative systems to streamline processes and drive down costs. Fortunately, I have a bevy of regulatory experts ready to share their knowledge and experience to help you meet your RIM goals regardless of where your company falls on the continuum.

Regulatory Information Management is Complex!

First, the regulatory landscape is complex and always changing so just keeping up with regulatory requirements across global markets is challenging.

Secondly, organizations are often in varying degrees of maturity when it comes to regulatory processes. Some organizations do not have a content management system in place to help manage all their controlled documentation including how documents are created, reviewed, approved, trained on, distributed for use, revised and retired.

On the other end of the spectrum, some companies manage multiple content management systems and are striving to rationalize them in a way that streamlines operations and (more…)

When Lightning Strikes Your Enterprise

Lightning strikes nearly 300 days a year, or 80% of the time, in Lake Maracaibo, Venezuela, which NASA has declared the lightning capital of the world (Source: NY Times). In today’s enterprise, what sparks that same level of energy? Your Content.

Whether structured or unstructured content, chances are your enterprise workers depend on interacting with your content, together with colleagues and business partners.

Lightning BoltCollaboration lights up your workflows when it comes to jointly-developed documents like FDA new drug applications, nuclear power plant drawings, or regulatory compliance documentation.

Customers I spoke with recently at EMC Momentum discussed three different types of content collaboration needs, many of which tie back to mobile solutions (full disclosure, I run our Enterprise Content Division Mobile Practice). Here is how I would characterize these varied dimensions of content collaboration:

1 – Bringing Offline Field Data into Your Enterprise

If there’s ever a place that needs collaboration, it’s at that intersection between content you capture offline, and all that’s living within your systems. Customers need to head out to oil pipelines, patient clinics, and crime scenes. Today, much of that field work is still (more…)

Continuing the Momentum

Now that the dust has settled after EMC World, I wanted to take a moment to say thank you to the 1,335 customers and partners who attended our Momentum Conference in Las Vegas. Momentum really is all about you. It’s about sharing information and learning from one another. It’s about open, two-way dialog and working together to achieve meaningful business results. And, of course, we do have a little fun along the way. It is Vegas, after all.

This year, we focused on digital transformation and the very real impact it’s having on so many of our customers. We launched exciting new products, like LEAP and InfoArchive 4.0, while also making great strides forward with our Documentum products to make them easier than ever before to deploy, upgrade and manage. We offered numerous opportunities to learn more about all of our products – in fact, of the total 400 hours of breakout content offered at EMC World, 100 of those hours were dedicated to Momentum. That’s right, literally one out of every four breakout sessions at EMC World focused on ECD products, customers, or partners.

Our attendance was up more than 20% year over year, which is fantastic, and we are so pleased that so many of you were able to join us in Las Vegas, particularly in a year when we will also host Momentum in Europe (more on that later). And, based on the (more…)

The Life Sciences Environment Is Evolving. EMC Documentum for Life Sciences Has Changed Accordingly. Here’s How.

We’re pretty excited about what our customers have been saying about our solutions—how much they appreciate the improvements in usability, collaboration, and seamless linking and sharing of content, just as a few examples. In my last blog, we examined the pressures that are driving them to adopt our solutions, and looked at some of the numbers: 6X growth over the past 3 years. Wow. How did that happen?

The quick explanation is this: EMC Documentum for Life Sciences solutions have changed to meet the evolving needs of the industry—in a very big way.

For our customers, it’s a wish come true. Think about it: seven of the top ten largest biopharmaceutical companies use our solutions. If they can protect and leverage their existing investments in Documentum—the industry’s most proven, trusted, scalable platform—by adopting solutions from EMC that integrate with it seamlessly, that is very good news. It’s perfect: they can stay on Documentum and still get comprehensive next-generation solutions from a single, trusted partner.

So what exactly did EMC do to build these business-specific solutions for regulated content management? I talked with Jennifer Wemstrom, senior director of product management for Life Sciences at EMC’s Enterprise Content Division, for her perspective.

Question: Jennifer, let’s start with what’s going on in the industry. What do you see happening?

Well, as in every other field, Life Sciences organizations have had to adapt to digital transformation. That means meeting today’s user expectations for ease of use, mobile-friendly interfaces, cloud availability, simple collaboration and so on. Users today are sophisticated and tech-savvy, and they expect to work with applications seamlessly. And globalization has made a huge impact, both the move toward outsourcing to contract research organizations and the like, and as well as expanding markets to emerging economies. Our solutions have responded to that reality.

And we recognized that, because of the need to respond quickly to ever-changing business needs, customers must limit the time and money they spend on customization. They no longer want to go it alone; in fact, they would far prefer to take advantage of best practices, standardization and lessons learned by their industry peers.

In that same vein is the desire to limit user training. Given demands for efficiency and cost control, there is simply no time for a learning curve, whether for new users at headquarters or at a local affiliate in, say, Brazil or China. It turns out that a great many people use the solutions only occasionally, which means that the experience has to be simple and intuitive. Infrequent users must be able to get it right away with minimal instruction.

Finally, and perhaps most important, we learned the importance of designing the solutions to drive process efficiencies and provide visibility across the extended enterprise. Users must be able to collaborate seamlessly, and to link and share documentation, with intuitive search capabilities. For example, multiple users should be able to edit a document simultaneously, and have the system automatically merge all the changes. And the central office must have visibility into regulatory activities, especially regarding local affiliates’ submissions, to assure accuracy, compliance and product safety.

Question: EMC has made a major commitment and significant investment in supporting Life Sciences. How have our offerings evolved as a result?

Most important is the integration of the various solution components, which are completely configurable and require zero coding. Companies can choose individual solutions that address the full drug lifecycle: compliant clinical trial documentation, research and development, storing and viewing of archived submissions, and control of quality and manufacturing documents. These are turnkey solutions; once they’re implemented, nothing more has to be done but to put them to use.

Each of these solutions uses standards and preconfiguration in document inventories, terminology and vocabularies that are driven by years of lessons learned, industry standards, as well as the latest guidance provided by the DIA reference models. This approach really speeds up deployment time, promotes harmonization and goes a long way toward ease of use thanks to familiar, repeatable processes.

And we are committed for the long term, looking ahead as we make ongoing investments.

Question: It sounds as though EMC brings a great deal of industry expertise to the table. Do you agree?

Yes. When we speak of investment, we mean people: over the past few years, we’ve brought in experts in product development, marketing, sales and services. That’s key, of course. And EMC already had 25 years of experience in Life Sciences. But equally important is our experience in content management. We have built all those years’ worth of lessons learned and best practices into our solution suite. In fact, EMC Life Sciences experts have led the way by extending the DIA EDM Reference Model to the quality domain.

Question: You’ve mentioned the importance of the user experience. Can you go into a little more detail?

These days, no matter what industry or line of business or job type, people expect a consumer-like experience. User interfaces need to be simple and intuitive. Tools need to be mobile-friendly so people can work on the go.

Our solutions are designed with all that in mind. And—this is an essential point—they are role-based and easily personalized, tailored to the primary tasks of that role. For example, the interface for a user who only reads content is different from that of someone who authors content. And the solutions can be personalized to ensure that everything a user needs is readily accessible. That’s what we mean by efficiency!

Question: How about the element of collaboration and sharing of documentation?

Our solution suite comprises what we call a unified solution layer that is built on a common data model. In short, the common data model ensures that all solutions across all domains are standardized; no more silos that function independently. So instead of importing documents from one system to another, documents can be shared and content reused. For example, a manufacturing specification is required simplify, simplified businessfor the submission, but is also maintained in the quality management system. The unified solution layer links the current approved content directly from one to the other. It creates a single version of the truth with content always accurate and up-to-date, and since the documentation resides in a single repository, it can be easily searched.

I also mentioned the importance of visibility across the enterprise. It’s the same concept. The corporate office can distribute the current, approved version of the content to the regional affiliates, while enabling them to create local content based on regional requirements and then communicate it back to headquarters. This not only helps maintain compliance, but reduces the workload. And here again: processes are streamlined and efficiencies gained.

Question: How can our readers find out more?

So glad you asked! Our readers are invited to attend Momentum 2016 at EMC World in Las Vegas, May 2–5. Stop by the Enterprise Content Division booth and see our Life Sciences solutions in action.

And you can see demos right in your office, just by visiting our online showroom.

Would you like to share your thoughts or experiences? Please comment here.

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