Betcha Didn’t Know We (At EMC Documentum) Did That!

Lori McKellar

Lori McKellar

Director, Market Development, Life Sciences

We’ve all experienced it. You’ve done your preliminary research for a vacation, car or other consumer good. After reviewing the websites of the top brands, checking out available ratings and reviews, and checking in with friends and family who may have made a recent similar purchase, you’ve gained some clarity but you are still confused. On the surface, all the options sound pretty similar. This familiar consumer experience also holds true when searching for solutions in life sciences.

If you look at the competitive landscape for life sciences solutions, you see multiple, viable vendors. Yet, if you peruse their websites, you’ll see a pattern of familiar and similar messages focused on performance, scalability, access, ease-of-use, efficiency, configurability, compliance, control, collaboration and cloud. With so many vendors extolling similar benefits to customers, how do you ask the right questions and make the right decision?

With so many vendors extolling similar benefits to customers, how do you ask the right questions and make the right decision?

It’s never easy. Buying cycles for significant, mission critical applications can be a complex process. The key is to cut through the clutter. To make a good decision, you need to search deeper and increase your knowledge and understanding. In our recent Life Sciences Customer Advisory Board meeting, our conversations not only focused on the “what” but more importantly, on the “how.” Understanding “how” vendors are delivering their stated value is key to simplifying decision-making.

Here are some examples of the “how” approach to get you thinking. Instead of taking the claim of global scale and performance for granted, ask how. Instead of focusing on a single business process, look beyond it to determine how critical information flows in and out of that process….is there an opportunity to share or link content instead of having to import and export the same information across systems? If cloud is important to you, understand how you would deploy it. What type of cloud solution do you need – private, hybrid, or multi-tenant― or maybe some combination of all three? And, it would probably be good to know how the vendor will get you from your current solution to the new solution and how to address all the (soon to be legacy) data that needs to be retained and accessible.

At EMC, we want to answer your “how” questions. And, we suspect that there’s a lot we’ve been up to lately that you may not be aware of. Therefore, we are launching a video series called, “Betcha Didn’t Know We Did That.” These are short, snappy and fun video snippets that highlight some of the ways we’re redefining life sciences with the EMC Documentum for Life Sciences solution suite.

We hope these videos will catch your attention, make you smile but more importantly, highlight challenges that we’ve all grappled with. We hope these videos entice you to ask us questions, have deeper conversations with us and understand the how. Our first video is focused on the regulatory submission process. If you’re looking to bring control to this mission-critical process, take a peek below. Keep checking back for new videos and the start of new conversations.Together, we can redefine life sciences!

What would you like to redefine? Share your comments below.

 

Don’t stop believing…in YOUR Journey to the Cloud

Dave Hsu

Dave Hsu

Marketing Manager for EMC’s Life Sciences Content Solutions with responsibility for building awareness, advocacy and adoption of EMC’s market leading clinical and quality offerings.

The musical band Journey…some people love them, some people REALLY LOVE them. I’ll admit that “Don’t Stop Believing” is a great song to play at sporting events when it’s time to rile up the crowd, but I’m not a super fan. Some say that their biggest hit song transformed Rock’n Roll in the early 1980’s, and you can’t argue with their sustained success. To this day, “Don’t Stop Believing” is still one of the top 25 most downloaded songs off of iTunes!

Similar to Journey, transformation and sustainability are two key tenants of Cloud computing. Nowadays it seems like there is a perception that if you’re not ‘in the Cloud,’ you’re a step behind everyone else.  One of the things I’ve been interested in, especially for the Life Sciences industry, is to understand if and how companies really are adopting Cloud services. Is everyone jumping feet first into SaaS for content management? If so, which documents/processes are moving? Which ones are staying on-premises? What key factors are driving decisions to move to the Cloud or not?

A recent report published by market research firm, ORC International called “The Journey to the Cloud for Life Sciences Content Management” delves into these specific areas. It’s a two-part series of findings with Part 1 analyzing the overall industry forces driving public Cloud adoption. Per ORC International:


“It was clear from Part 1 of our research that the need for stronger regulated content management has never been more important to ensure compliance and fast time to market for life sciences companies. We found that industry forces are both driving and hindering adoption of public Cloud. Additionally the risk-averse nature of the life sciences industry is further hindering adoption of public Cloud, except for areas where there is less regulation such as sales, marketing and HR. The journey to the Cloud for regulated content management is extremely complex and challenging for the industry.”

- ORC International


You can download the report here.

My takeaway from the report is this: the journey to the Cloud is YOUR journey. Every organization is different and a one-size-fits all approach to Cloud does not provide you flexibility or control.  When researching Cloud solutions, make sure your vendor can provide you with the delivery options, configurability, and flexibility that meets the needs of your business.

Stay tuned for Part 2 of this paper from ORC that looks into the business needs of both large and mid-size life sciences companies, and provides a landscape of solution options available for regulated content management.

In the meantime, don’t stop believing in your Journey to the Cloud. For inspiration you can even go see Journey live next year in the Virgin Islands! If you have any feedback or key insights from the ORC report please share them below. What’s driving or hindering your Journey to the Cloud?

When Taking a System Offline Is Acutely Unacceptable

Tom Broering

Tom Broering

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

Keeping enterprise-scale repositories online with minimal downtime to handle backups, data repair and recovery saves more than dollars, as Mike Fernandes, VP, Products, enChoice, can attest. Read his blog below to understand the truly critical impact of backup and recovery in today’s connected world, particularly in the highly regulated industries that EMC and enChoice serve.

When Taking a System Offline Is Acutely Unacceptable

Mike FernandesMike Fernandes, VP, Products, enChoice
Mike Fernandes has over 20 years’ experience in the technology industry encompassing the management of IT departments, online banking hosting centers, and B2B support organizations.

In life sciences, energy, financial services and just about everything else, compliance is the 800-pound government gorilla in the room. Following the rules has never been simple, but the often mind-boggling complexity of the process for regulatory audits, inquiries, inspections, and eDiscovery, plus industry-specific documentation requirements with all their associated demands and deadlines, makes it almost unthinkable to take a major system offline for any significant length of time.

Imagine the consequences if a major bank runs afoul of Dodd-Frank because of a glitch that interrupts the mandated capture and preservation of data at numerous points along the value chain. Now imagine the compounding of the pain when ordinary recovery processes, requiring a system shutdown, trigger permanent data loss or corruption.

At each stage of a drug’s development, the FDA watches everything from software systems to labeling information, all with strict guidelines for record retention and compliance. Violations can halt production, delay or deny an approval, and patients who need the drug, don’t get it, certainly not when they expected it. Data must be protected, and 24-hour or multi-day downtime windows for fixing problems is not an option.

NuclearFrom OSHA to FERC, operating an energy enterprise is a nonstop exercise in regulatory routines with little leeway. Non-compliance can lead to significant fines, business shutdowns, and a damaged reputation. Not to mention the lights going out.

Next-generation data protection software, like our CYA HOTBackup and CYA SmartRecovery solutions, appeal to organizations concerned with compliance issues, because they factor in the human cost along with the dollars. Having the ability to back up your ECM system without shutting down, without risk of data loss or corruption, cannot be underestimated. The capability to recover from operational incidents in minutes, with everything running, instead of after 24 hours or even days of system inactivity, is a game-changer, and it’s going to become equally attractive elsewhere.

We are exploring deployment possibilities in areas where the human cost of taking a system offline, even for a short time, is acutely unacceptable, and data loss, no matter how small, is intolerable. Judicial. Military. Corrections. Places where for obvious reasons, records cannot afford to go missing or get damaged, and slow, imperfect recovery can be disastrous. We expect broad acceptance as the benefits become apparent. Because so much is at stake.

How would a data disruption affect your compliance environment? Have you dealt with compliance violations brought on by corrupted or lost information? Let us know.

Can’t See the Forest for the Trees in Life Sciences?

Lori McKellar

Lori McKellar

Director, Market Development, Life Sciences

People usually use this phrase when trying to describe the tendency to become too involved in the details of a problem versus looking at the situation as a whole. Could thissunrise in a forest same concept apply to an industry such as life sciences?

During our webcast, “Improve Compliance by Gaining a Complete View of Regulatory Activity” held earlier this week with IDC, we polled the audience.

  • The first polling question asked, “Which of the following is a primary concern at your organization today?” 37.5% of the respondents answered, “Eliminating data silos and creating a unified information architecture.”
  • The second polling question asked, “What would you consider to be your highest RIM priority in the next 2 years?” 57.9% of the respondents answered, “Centralizing/integrating systems to unify RIM functions (single authoritative source.)”

In an industry where most life science organizations have historically taken a siloed approach to product development—that is, they create, manage, and store information by function (clinical, regulatory, manufacturing etc.); could these survey results indicate a potential opportunity for transformative change?

Well, let’s start with how information flows across the lifecycle of a drug in a pharmaceutical company today. As a new compound is discovered and goes through non-clinical and clinical testing, information must be shared internally with Regulatory Affairs (and ultimately with health authorities) in order to gain approval. Information from across the drug development process must be shared and overviews, study reports and summaries authored, reviewed and approved. Once an application is submitted to the regulators, there are on-going interactions with them through approval, and then continuing on for the life of the drug. Upon approval, specifications and formulas which originated in R&D, now have to transfer to production manufacturing. And the process continues on through sales and marketing, pharmacovigilence etc.

So, what would the process look like if it was redefined? How transformative could it be? What if information residing in each functional area could flow seamlessly throughout a drug’s lifecycle? For starters, workers wouldn’t have to export and import information from Diagrammsystem to system along the drug development lifecycle. By leveraging a consistent data model, information could be linked across solutions. This could reduce the risk and inefficiencies of manually exporting and importing information, stem the proliferation of multiple copies and eliminate the difficulty associated with determining final versions of documents. In addition, this would provide an authoritative source for drug development information and provide detailed audit trails across the process. Most importantly, it could help streamline the process helping to get needed drugs to market faster. This makes sense, doesn’t it? Organize information according to the business process and lifecycle of products rather than by business function.

What do you think? Do you think your organization is beginning to see the forest that includes the trees and embark on this type of transformation?

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.