One Decision to Make Today

Adam Kelch

Adam Kelch

EMC ECD Product Manager – Documentum for Life Sciences Clinical Solutions

Managing a pharmaceutical business involves great complexity, yet there is a simple decision you can make today – adapt your information flows to your drug development lifecycle, not to your org chart. This one decision will impact both your daily operations and your strategic advantage.

Day-to-Day Impact:

Status quo among many Life Sciences firms involves exporting digital document sets from one domain (e.g. Clinical), just to share them and re-import to the next organization (e.g. Regulatory). Yet based on the DIA TMF and DIA EDM reference Connectivitymodels, at least 20 documents initiated in one part of your organization will need to “cross-over” for reuse and trust in other parts of your organization.

These documents are necessary for your eTMF for compliance purposes, and only the “latest and greatest” need to be submitted to the regulatory authorities. They’re the same documents, living in different part of your organization!

The result?

No single source of information truth as your discovery progresses toward commercialization. Worse, the inability to find the most recent copy of your documents to fully comply with regulations. Worse still, insidious inefficiencies that chip away at your competitive advantage as these documents individually traverse your organization through email or who-knows-what medium.

By letting go of sharing documents “the old way” and adapting to one shared repository for both TMF and regulatory documents, you can improve productivity, time-to-market, and even morale (who in Regulatory likes finding out about a protocol change during the conduct of a trial after they just spent months completing a submission?).

The new way to handle documents is by leveraging the tried and true – still using Documentum, but choosing Documentum eTMF and R&D solutions to solve both Continue reading

What Happens in Vegas, Stays in Vegas… or Does It?

JD de Haseth

JD de Haseth

Director, Marketing — Cloud Services in the Enterprise Content Division (ECD) at EMC Corporation
Director, Marketing -- WW Cloud Services @ EMC Enterprise Content Division

A visit to Sin City as a content management aficionado makes it impossible to keep what happens in Vegas a secret. I returned from Momentum and EMC World 2015 eager to share with customers all the ways they can leverage the cloud as an underlying foundation for their enterprise content management strategies.

In terms that any Las Vegas visitor might appreciate, here are my top four EMC World 2015 insights to share. I hope these ideas and case studies inspire you to forge ahead and become the Digital Enterprise of tomorrow.

1 – Headaches arise from complicated IT application rolls-outs, not just from hangovers.

An estimated 80% of large enterprises will have deployed cloud environments by 2017, according to a 2014 Gartner Survey. As organizations transform into the digital enterprise, a razor-sharp focus on technology — and specifically, cloud deployments — will be the enabler to realize the next phase of growth. CIO’s and IT Director roles all rated “cloud is a modern approach,” “innovation” and “operational agility” as prime reasons on why making the journey to the cloud is a necessity today.

As EMC’s Enterprise Content Division showcased in the exhibit halls across EMC World, EMC enterprise content rationale to move to cloudmanagement solutions and products are available in a number of cloud deployment options. Deploying EMC Documentum in a public, private, or hybrid cloud helps alleviate installation and configuration challenges by leaving the complicated work to EMC technical experts. Depending on your needs, you may find that either a public or a private cloud model is a best fit. In some cases, it may be a combination of the two options – a hybrid cloud model. Bottom-line: it’s comforting to know that with EMC Documentum, you have choices! Talking with EMC experts, you can determine which cloud deployment model is right for Continue reading

The Best of the Best of the Best

Jason Capitel

Jason Capitel

Chief Revenue Officer, EMC Enterprise Content Division

The Best of the Best of the BestYou may not remember it, but there’s a line in the movie Men in Black where a character opposite of Will Smith says, “We’re here because you’re looking for the best of the best of the best, sir!”

This line came to mind as we were preparing for the EMC Enterprise Content Division (ECD) Partner Awards Dinner this week at Momentum at EMC World.

It’s no secret that our partner ecosystem is the best in the content management industry. Many of the solutions that they’ve built on our products have transformed the way that organizations – ones that you know or even work for – do business. They’ve helped these organizations thrive, and ultimately do amazing things like save lives and preserve historic documents. And they’ve helped EMC ECD be named a “Visionary” in the Gartner Magic Quadrant for BPM-Platform-Based Case Management Frameworks.

These partners, and those that resell and implement our solutions, are an extension of our EMC family. Many of them have been with us a good portion of our 25 years and are dedicated to seeing that our mutual customers are successful (by the way, you can help us celebrate our 25th Silver Anniversary by supporting charity: water).

In particular, I’d like to highlight International Turnkey Systems (ITS), the winner of our President’s Award for Customer Satisfaction. Both Rohit and I were impressed by ITS and their many stellar references. Consistent throughout was the emphasis on clear, dependable communications and thorough expectation setting. It was apparent that this partner is as passionate about having truly delighted customers as EMC is.

Although it was difficult to acknowledge just a few out of this fantastic ecosystem, I’m proud to announce the “best of the best of the best” and share my sincerest appreciation for all that they do.

Please join me in congratulating these partners on their tremendous effort and successes!

PHOTO FROM AWARD DINNER AWARD WINNING  ORGANIZATION AWARD DESCRIPTION/ SOLUTION NAME

Nasr Albikawi and Remy Foudapres award winner ITS

President’s Award for Customer Satisfaction International Turnkey Systems (ITS) Strategic focus on customer service; Exceeds customer expectations with the highest levels of satisfaction in services and solutions.

Bhavani Balasubramaniam and Suresh Ramachandrancosi

Innovation Award: Best Value Office Solution Cosi Consulting Insight

Gary Hodkinsoninoovo

Innovation Award: Best Capture Solution inovoo NOVO Mobile

Tim Nelms and Ernie Crawfordcrawford

Innovation Award: Best InfoArchive Solution Crawford Technologies PRO Archiver for InfoArchive

Bruce BoltonPortford

Innovation Award: Best ApplicationXtender Platform Portford Solutions DocuNECT Lifecycle Platform

Mario Duckettmario metasource

Innovation Award: Best ApplicationXtender Solution MetaSource MetaStor – ApplicationXtender for the Cloud

Ed Stevens

Innovation Award: Best Design Integration Award (OEM) Cerner Content 360

KEvin tompsettwindward mktg

Marketing Excellence Award The Windward Group Embracing EMC digital marketing tools and content, and going above and beyond with digital marketing efforts

Joe Mihalikflatiorns2

Partner of the Year – Overall Flatirons Solutions Revenue contribution and focus on building solutions that support ECD’s revenue priorities in 2014

James Robinson and Nikki Hansellpaperfree

Partner of the Year – AMER PaperFree (same as above)

(No photo available)

Partner of the Year – APJ Impact Systems (same as above)

(No photo available)

Partner of the Year – EMEA Deloitte (same as above)

 

EMC Documentum for Life Sciences Solution Suite 4.0 – A Proactive, Efficient and Simple Approach

Lori McKellar

Lori McKellar

Director, Market Development, Life Sciences

Industry pressures are prompting Life Sciences organizations to adopt new business models, enter new and emerging global markets, and expand alliances and partnerships in order to deliver high quality, safe drugs to market faster to improve health and well-being at a lower cost. To achieve these goals, life sciences organizations are becoming more strategic in how they manage information.

While ensuring regulatory compliance always has been and always will be a must, organizations are looking to drive efficiency and productivity across all aspects of the business. This requires breaking down artificial information silos and re-looking at how information flows from drug discovery through development, into commercial manufacturing and beyond. EMC can help!

A Proactive, Efficient and Simple ApproachFuturistic flowchart

As organizations strive to streamline how information is shared across the organization, they need to look at relationships that may exist between documents and how related communication flows between departments. Simultaneously, organizations can use this mapping of “information flows” as an opportunity to identify and build more automation into critical business processes while simplifying the user experience to make workers’ day-to-day jobs easier and more intuitive.

EMC Documentum for Life Sciences Solution Suite 4.0

Today, I am excited to announce EMC Documentum for Life Sciences solution suite, version 4.0. This release delivers proactive, automated, business rules and enhancements across the suite while ensuring a simple, user experience to reduce risk, streamline processes and boost worker productivity.16887-EMC-LS-ECN Banner-740x265

This release also serves as the foundation for future public cloud offerings in life sciences which will provide customers with ubiquitous access, unprecedented choice and flexibility in deployment models, faster implementation times and lower costs.

The 4.0 release, available later this quarter, provides specific business enhancements to each solution in the suite and also provides a broad set of capabilities that can be leveraged across the entire suite.

The Highlights

Enterprise information architecture: As mentioned, the documentation involved in bringing a drug to market must be continually shared across the organization and updated throughout its lifecycle. Therefore, documentation must cross functional boundaries. By leveraging common document and data models across the solution suite, organizations can seamlessly link and share content across the iStock_000012775593XSmallorganization. Today, most organizations export and import documents from one system to another, resulting in version control and traceability issues, multiple copies with no official copy and manual processes resulting in extra work. With EMC, organizations can create a single authoritative source for regulated content, seamlessly link and share content across departments (or divisions) and provide proactive notifications to document authors, owners and users when document changes take place or actions and tasks are required.

EMC Documentum Quality and Manufacturing: Instills proactive notification and automation into key business processes such as periodic review, change request and the technical transfer processes to reduce risk and increase efficiency. Enhanced reporting quickly provides a snapshot of controlled document compliance.

EMC Documentum Research and Development: Extends the solution to include labeling and safety document inventories, the ability to use controlled templates to create virtual documents as well as a proactive, automated expiry review process.

EMC Documentum Submission Store and View: Boosts regulatory worker productivity through enhanced regulatory activity tracking and granular eCTD viewing.

EMC Documentum Electronic Trial Master File: Enables investigators to directly view, import and complete tasks on required clinical documentation via an investigator portal. Also, enables documents shared between clinical and regulatory functions to be linked creating one, source document and ensuring proactive notification when changes occur.

Want to Learn More?

If you are lucky enough to be attending Momentum at EMC World this week, please be sure to attend the life sciences sessions. In them, you’ll get a better understanding of these new enhancements, view demos and find out what’s next on the horizon.

Please visit us next week, May 11th – 13th, at the Drug Information Association (DIA) eRegulatory and Intelligence Conference in Philadelphia. We’ll have two experts presenting and members of our Product Development team will be available to talk with you about the specific challenges you’re facing.

If the process of transferring R&D documentation to Commercial Manufacturing is something your organization struggles with, keep an eye on EMC Spark. Jessica Kelley, Quality Product Manager, recently wrote a blog on the challenges associated with this process. In her next post, she’ll be explaining how you can automate the process (think – one click!) while ensuring traceability.

We are excited by all the new capabilities we have to help your organization become more strategic, efficient and productive. So tell us how we can help you!

• What are your most pressing challenges?
• What processes need to be automated (or need tighter integration?)
• Where do communications related to shared documentation break down?