InfoArchive – A Customer C-Level Show-Stopper

John Heck

John Heck

Director of Business Development Financial Service Industry – North America

The Solution

What’s InfoArchive? It’s is a unified archiving platform capable of storing very large amounts of related structured and unstructured content in a single repository. When utilized, our customers can reduce the risk of long term information retention associated with regulatory and policy compliance within a single consolidated archive. It also improves application performance and reduces data center costs by archiving high-volume static information. Lastly, it eliminates the overhead of legacy and duplicate applications while retaining valuable information in an easily accessible unified archive.InfoArchive cluster4

As a brief background, a European bank needed to build a compliant archive for both
transaction documents as well as structured data from core banking applications and the ultimate solution needed to support archiving for high volume transactional data commonplace in this banking arena.  In short, it needed to scale to archive billions of objects.  So, it was InfoArchive that was deployed to archive high volumes of regulated static information. The product met the scalability needs as well as delivering a next-generation platform built on open and accepted archiving standards.

Recently, EMC InfoArchive was recognized as a “Visionary” in Gartner’s Structured Data Archiving and Application Retirement Magic Quadrant and as a Trend-Setting Product of 2014 by KM World.  So why is InfoArchive such a “big deal”?

I feel the easiest way to sell anything to a financial institution is to deliver a transformational solution that can be justified via a CBA (Cost Benefit Analysis) approach.  This can be accomplished from a bottoms-up and / or a tops-down sales methodology.  An example of the former, application decommissioning and records management initiatives can be upper mid-leveled sponsored by our customers from a budgetary basis and fairly easily quantified.  Each of these approaches can be utilized to create customer value with a phased approach leading to an enterprise InfoArchive solution.

A tops-down approach can be launched with the C-Level leadership with a more holistic objective; addressing decreased IT budgets, reducing compliance and regulatory issues as well as saving on storage costs.

90% of the world’s data was created in the last two years.  Think about the amount of data being created each new day for the top twenty global banks; how on earth are they going to address this data tsunami?

The reality of reduced IT budgets is upon us; every CIO is being asked to do more with less.  According to the US Chamber of Commerce, 90% of the world’s data was created in the last two years.  Think about the amount of data being created each new day for the top twenty global banks; how on earth are they going to address this data tsunami? In addition, how can a bank quantify the aggregate amount of fines and penalties they will incur if they don’t do something to proactively address this issue?  The approach of many large banks is when in doubt, save EVERYTHING!  In many cases, that in itself is a compliance violation.

So what’s the answer?  InfoArchive ensures better compliance, achieves storage savings and the ability to scale with an inordinate amount of data being added at a record-setting pace.

InfoArchive – a Measurable Value Proposition

What’s in it for you?  Take for example a large bank that has about 150 PBs of data.  What’s their best option? It is to proactively address their compliance needs and application decommissioning issues and while doing so, save 34% of their current storage costs. Saving one-third of storage costs is definitely transformative. But let’s not stop there: think about what Finance can save in terms of operational costs and the gains that can be achieved from risk mitigation and compliance. Now, we’re talking true transformation.  Our proposal not only addresses their compliance and application decommissioning needs, but over a three year Term, we’ll save them at least 34% of their storage costs!

In summary, InfoArchive reduces operational costs, proactively addresses compliance and regulatory issues and significantly reduces storage costs.  Why not join others like you and begin to transform your data enterprise today?  Share questions you may have in the comments below. For additional InfoArchive information, contact your Information Intelligence Group Account Manager directly or by contacting EMC.

Embracing Change in Regulatory Information Management

Steve Scribner

Steve Scribner

More than 20 years experience in business strategy and implementation of Content Management in Life Sciences

“Companies that are still relying on paper or Excel spreadsheets to track their regulatory submissions are missing out on much of the value that their documents contain and the benefit of having a comprehensive view of regulatory activity. Working transparently in many ways, life science-specific content management solutions like EMC Documentum SSV have best practice intelligence built in, delivering value to projects both today and for projects yet to come,” says Dr. Alan Louie, Research Director, IDC Health Insights

alan louieWe welcome Alan S. Louie, Ph.D. Research Director, of IDC Health Insights as our guest blogger today on embracing change in regulatory information management. Read on as he shares his thoughts with us:

The persistence of elegantly crafted and refined paper templates and Excel spreadsheets to manage regulated documents and processes in the life sciences can in large part be attributed to a strong resistance to change, the lack of time, money, and a measurable ROI needed to assess and validate new solution approaches. At the same time, the increasing use of external partners is further complicating document and process management for regulatory and IT staff, with many key project and process managers increasingly residing outside of the organization and often thousands of miles away geographically. While it may have been possible in the past to walk across the hall in the past to collect a signature or determine the status of a submission, today’s efforts routinely rely on less personal phone or email to track project status and hear about issues that may arise. As an additional concern, documents supporting regulatory compliance often resides across multiple systems, including email, separate document repositories, individual laptop/desktops, and manual filing systems.

lifescissv blog imageBeyond conversion to electronic versions of their historically paper documents and processes, electronic content management systems (CMS) are designed to capture supporting metadata that can add significant immediate value to regulated documents and processes. Effective content management systems can also contain significant embedded intelligence by translating industry best practices into automated workflows that can be used to automatically identify omissions and discrepancies, highlight important deadlines, assess whether a submission is complete (and identify missing documents, if any), and enable extended use of data, information, and knowledge beyond the project at hand. From a regulatory compliance perspective, use of enterprise regulatory information management (RIM) solutions brings required documents into a single repository, facilitates more effective information access, sharing and review on a global basis, and simplifies responses to regulatory inquiries and audits.

While often presented as a more effective approach to managing and responding to regulatory audits, IDC has seen few cases where this was the primary driver for conversion from paper or an Excel spreadsheet to a CMS or in this case, a RIM system. In most cases, additional benefits must be realized for investments to be made. Reduction and/or elimination of low value, repetitive activities at the operational level, improved process reuse for related efforts, improved compliance across partner organizations, and more real time monitoring and analyses of ongoing project efforts are regularly mentioned as key drivers of CMS implementations, with measurable ROI helping to justify investments to the C-suite. For RIM systems in particular, capturing and tracking of correspondence with regulatory authorities can come in multiple forms, including paper, email, and phone. While heavily time consuming to track retrospectively, systematic access to this information can better inform ongoing project efforts on a global basis, simplify compliance, and help to reduce the insanity of regulatory audit fire drills.

Regulatory information management (RIM) systems are helping regulatory organizations to work more efficiently and effectively. At an industry level, RIM solutions that reflect key industry (and company-specific) best practices are helping companies to maintain global compliance in an increasingly complex global ecosystem while freeing up remaining key staff to concentrate on more important concerns such as handling agency interactions rather than providing updates, status etc. The ongoing and well advanced transition away from legacy solutions in the life sciences reflects the increasing maturity of commercial solution offerings and their ability to advance efforts that build on well-established industry best practices and bring enhanced levels of compliance and efficiency to key business processes.

To learn more join EMC Life Sciences experts and me (where I’ll be a guest speaker) for an upcoming webcast October 21, 2014 at 11am ET.

Boston Is Not Beijing for Life Sciences Marketing

Tom Broering

Tom Broering

Head of Americas Alliances and Channel Sales, Information Intelligence Group at EMC

Next week, EMC and some of our partners will be exhibiting at, and participating in, the DIA EDM and ERS 2014 event in Washington, DC, to explore evolving global trends in e-records, systems and e-context in the Clinical and Regulatory space. I thought it was fitting to share some insights about the global differences that Ameen Datoo, Principal Consultant at EMC Certified Solution partner, Paragon Solutions, sees as he  works with life sciences clients on streamlining globally regulated content.


Boston is Not Beijing for Life Sciences Marketing
by Ameen Datoo, Principal Consultant, Paragon Solutions

paragon-logo

Social scientists like to talk about the world getting smaller, and borders disappearing. They point to how global connectivity is enabling us to reach out and touch anyone, anywhere at any time, and how multinational corporations are spreading their ubiquitous brands across continents.

But a smaller world is not necessarily a simpler one. And no one understands that better than those who navigate regulatory differences in the life sciences industry.

Life sciences companies must manage vast amounts of information to effectively and legally market their products around the world. Few things are more complicated. Selling the latest wonder drug in Boston is not at all the same as selling it in Beijing. Designing a promotional campaign that works in both locales, and many more in between, is far from simple or straightforward.

At home or abroad, compliance is the biggest driver of that complexity. In the U.S.A., it’s difficult enough to track, support, document and verify every claim in every piece of domestic promotional material through creation, revision, approval and submission to the FDA. It’s a major challenge to connect all the relevant players: medical, legal, quality control, ad agencies; at every stage of approval.

Now imagine multiplying that effort, country by country. Every government writes its own regulations. France drafts requirements similar to those of its Euro-neighbors, but China goes largely its own way. Moscow demands proprietary considerations that are unknown elsewhere (not to mention the cultural differences that can turn a brilliant promotional piece in Location A, into a coarse or vulgar insult in Location B).

No regulation in any country can be taken lightly. Penalties for even minor lapses can be steep. Failure to provide fair balance or worse, engaging in misleading claims, can cost billions.

Prescription Medication Medicine Pill TabletsNor can the industry shrug off international sales. The studies are clear: Drug companies that hope to keep growing are going to have to do it overseas, in the so-called “pharmerging” markets: China, Russia, Brazil, India, etc.

Old information management systems that relied on emails, file-sharing, a few spreadsheets and the like, are no match for these global challenges. But newer “generic” solutions not built specifically for life sciences often lack the industry savvy to do the job, potentially leading to critical, even dangerous gaps.

To those of us working in Life Sciences ECM, the message is clear: pharmas and other life sciences organizations must seek out and adopt industry-specialized solutions for promotional materials management. These solutions need to be capable of connecting multiple players, handling multiple drafts, on multiple platforms, and in multiple cultures. That’s a level of subtlety, flexibility, and adaptability not easily achieved, yet with our current technology it is a reachable goal. Visionary information management companies are getting it done right now, indeed making the world smaller. And simpler too!

Do you have a specialized technical solution for managing promotional materials? Should you?

A Complete View of Regulatory Activity is Greater Than the Sum of its Parts

Steve Scribner

Steve Scribner

More than 20 years experience in business strategy and implementation of Content Management in Life Sciences

Regulatory Submission Management is an extensive process that requires many integrated capabilities. In my initial blog, I likened the process for submitting a drug LifeSci SSV-2application to regulatory authorities as being similar to completing a mortgage application. Bio-pharmaceutical companies have to keep a current, complete and concise record of all their drug applications with the government agencies in each market of the world. That requires a record of exactly what was submitted, plus a thorough collection of correspondence from the first contact to the last update.

I then validated the industry need by referencing the survey and the analytic work performed by Gens and Associates. Their survey results indicated that 78% of respondents plan to change their Heath Authority Communication solution in the next 2 years. It would seem that what is needed to solve this challenge as an integrated solution is missing or at least not meeting all the industry requirements.

With the challenge outlined and the need validated, I then looked at how this process could be redefined. To meet these business needs, a solution would need to have a solid answer for importing submissions, published by a variety of tools (both current and legacy.) It would also need the ability to easily import correspondence from multiple systems (local storage, collaborative spaces, file shares and email systems.) Ideally, this information would be integrated into a common repository so that a comprehensive view could be achieved and easily searched with minimal effort. The end result would be a tool that could be easily used by Global Regulatory organizations anywhere and also fit the needs of participants in the development lifecycle and external organizations (affiliates) so that a consistent message could be conveyed with all agencies.

Today, EMC is announcing a new solution that aims to deliver on these needed capabilities. Documentum Submission Store and View, part of the EMC Documentum for Life Sciences solution suite, links regulatory correspondence and communications to submission files, enabling a 360-degree view of regulatory activity. It also automatically stores eCTD, NeeS and paper submissions into a scalable Documentum repository that delivers advanced security, audit trail, metadata and indexing capabilities. More specifically, Documentum Submission Store and View enables:

Regulatory submission and associated communications storage in a compliant and secure repository that includes audit trails and indexing for more efficient tracking of submissions and queries and a complete view for better clarity and understanding with regulatory authorities.

  • Easy access and view of regulatory correspondence that’s linked with submissions, which includes an out-of-the-box integration with Microsoft Outlook and follows a best practice document taxonomy for submissions and agency correspondence.
  • Quick search and retrieval of archived submissions and associated documents using a faceted navigation on metadata properties such as product, country, manufacturer, submission type and date.
  • Streamlined viewing of Electronic Common Technical Document (eCTD), including the full regulatory submission lifecycle, even the navigation of inter-document hyperlinks.

Documentum Submission Store and View extends EMC’s commitment in the life sciences regulatory arena by addressing a critical aspect of the regulatory submission process. This new addition to the Documentum for Life Sciences solution suite means Life Sciences organizations can now gain a complete view of regulatory submissions and related correspondence in a single, compliant solution. By integrating correspondence and submissions in one view, regulatory workers can be freed from constant requests for status updates etc. and focus their time on more important tasks at hand – having timely and quality interactions with health authorities.

Learn more about the latest SSV announcement on the EMC Pulse Blog, Video, and upcoming Webcast.

IT Transformation: Why IT Housekeeping Makes Sense

Alan Hutcheson

Alan Hutcheson

Expert on enterprise archiving strategies including application decommissioning and active archiving.

As organizations and CIO’s seek to balance the current demands of business users and the need to transform corporate IT to deliver cloud based services that are more flexible and responsive, the IT budget imbalance becomes a significant impediment. As we all CIO-Challenge
know, 70% of the available budget being spent on “keeping the lights on” (take a look at this), so there is little room for maneuver for a CIO seeking to transform their IT operations.Shadow-IT

Hamstrung by these limitations, CIO’s we meet tell us of their frustration as so called shadow IT has emerged with budget holding line of business users increasingly
bypassing corporate IT and contracting direct with suppliers for services.

The problem seems clear; how do you reduce the costs associated with managing the existing application portfolio and infrastructure to enable reinvestment in cloud and new services?

To answer this question there are a few issues to consider:

Legacy applications:

  • Which applications are really needed by the business
  • What data and information managed by these applications needs to be retained

Production applications:

  • Which applications can be migrated to a cloud environment and what are the benefits from doing so
  • How to minimize the costs of those applications that remain in corporate data centers
  • How to manage the data growth problem: 30% – 40% annual growth rates are standard

Something that provides an opportunity to address these issues is so called “inactive” information. This is data or content that has reached the point in the business process where it will no longer change so is in its final form (e.g., an invoice, a payment transaction). This information can be moved from the production applications where it was created and managed in lower cost environments as long as it remains accessible to business users for reference and reporting.

Inactive-Data-GartnerMany legacy applications contain only inactive information and Gartner suggests that between 60% – 80% of information in production applications is inactive.

The opportunity to reduce costs by migrating the data from legacy applications containing only inactive information to a suitable optimized management platform and decommissioning the applications completely is potentially enormous. I have seen savings of $5M per year being achieved within 4 months through targeted application decommissioning.

With production systems, not all inactive information can be migrated to a low cost platform as it is needed within the application for reporting. However selective, periodic migration of information based on suitable business rules can result in significant cost savings in terms of storage and backup as well as providing a way to “right size” infrastructure to control costs and manage data growth.

A final consideration is to ensure that this kind of housekeeping based on effective management of static information also enables support for the new services that the business is seeking to develop. This means that the static information that has been secured in a cost optimized environment is accessible and can feed new applications or services that are required by the business.

It’s clear, then, that what’s needed is a comprehensive plan to re-balance the IT budget in favor of innovation by addressing the historical complexity of application portfolio’s and inefficient data management practices.

Now is the time to ask what is your organization doing to retire legacy applications to make room for new applications to transform your business? Share your insights by commenting below.

Stay tuned for my next blog where I will look in more detail at some of the elements of IT transformation programs.