Next Generation Enterprise Content Management (ECM) in Life Sciences

Lori McKellar

Lori McKellar

Director, Market Development, Life Sciences

According to a 2015 Life Sciences Industry survey conducted by Gens & Associates, 68% of respondents are expecting significant change in enterprise content management (ECM) solutions in the next 3-5 years. In my previous blog, I addressed the first two drivers of change – improving operational efficiency and enhancing usability and end user productivity.

As a quick recap, Life Sciences companies consider regulatory compliance a given. They must comply, period. Companies are now looking for ways to drive efficiency across not
Change vs Sameonly functional domains but also across divisions. Life Sciences companies are also looking to improve usability and end-user productivity. Business users today are demanding “consumer-like experiences” to help make doing their daily tasks simple and straightforward. Business solutions must be crafted in a way that work can easily be done within the official, regulated content management system – not via workarounds and complex integration’s with third party tools.

Now that we’ve done a brief recap, let’s focus on the remaining two drivers of change in Life Sciences ECM: upgrading outdated technology and improving information flows with regional and local affiliate offices.

Upgrading Outdated Technology

Earlier this week, EMC hosted a webcast on “Next Generation ECM in Life Sciences – Three Critical Themes for Success.” During the event, the desire to upgrade outdated technology was attributed to two things.

First, many companies who deployed their solutions several years ago now are in the natural cycle of reviewing these investments. This makes total sense. While these systems have clearly met the needs of the organization over time, they may not be serving all the current organizational needs. When you think of all the change that has happened in the Life Sciences industry in the past ten years – the volume of mergers and acquisitions, the expansion into new geographies, the proliferation of partners – the Life Sciences business has been continually changing and evolving.

Secondly, in addition to the continually changing business climate, you need to also take a look at it from the technology side. Here, the pace of change has been just as dramatic. Organizations are tasked with consolidating infrastructures that often have duplicated systems in place due to heavy M&A activity. But the information and data that resides in Continue reading

Next Generation ECM in Life Sciences

Lori McKellar

Lori McKellar

Director, Market Development, Life Sciences

The Life Sciences industry is in a state of transformation. While the industry is driven by innovation, the complexity involved in bringing a drug to market can make the decision making process of how best to foster it and achieve it, difficult. Companies often struggle with determining whether smaller, incremental changes can make enough of an impact or if larger, more strategic changes are required. Determining the end goals, priorities and budgets to support these key initiatives is never simple.

While there are many facets to developing, manufacturing and selling drugs and devices in Life Sciences, content (documentation) is an area that is common to all aspects of the business. While many companies tend to work in silos with each domain having its own processes and systems, it’s often the content associated with the drug that “moves” with it throughout the drug lifecycle. This puts content management in a unique position to help break down information silos and help drive greater efficiency across the organization and its extended partner network.

According to a 2015 Life Sciences Industry survey conducted by Gens and Associates, 68% of respondents are expecting significant change in enterprise content management solutions over in the next 3-5 years. Four drivers of industry change were identified:

1) Improve operational efficiency
2) Enhance usability and end user productivity
3) Upgrade outdated technology
4) Improve information flows with regional and local affiliate offices

In part one of this blog, let’s take a look at the first two drivers identified and how they are driving change in both the content management landscape and the Life Sciences industry. Next month, I’ll come back with part two and address the second two drivers.

Improve Operational Efficiency

Earlier this year, I wrote a blog post asking, “Is Efficiency Replacing Compliance as the “Big Stick” in Life Sciences?” This question was based the Gens & Associates 2015 Winter Edition of their Annual Regulatory Information Management (RIM) Whitepaper. The basic concept conveyed was that compliance is now considered a given and executives are looking to drive efficiency and productivity across the organization while still ensuring compliance.

I mentioned that content is often associated with a specific compound, drug or formulation and can “follow” the drug throughout its life cycle. What if clinical information could be shared seamlessly with the Regulatory team? connected networkWhat if the regulatory submission information for a now, approved drug could be seamlessly transferred to Manufacturing for scale up production but done in a simple, automated, GMP-compliant way? And what if there was a change to a document and the appropriate teams were notified so that they could proactively assess the impact of that change? This is all possible today and can fundamentally change how organizations work.

But breaking down functional and divisional information silos is just the start. There are additional efficiencies that can be gained when extending processes to include partners as well. Hopefully you can see that a fundamental shift from silos of information to a consistent, enterprise information architecture can result in a single source of the Continue reading

Ready, Aim, Cloud

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

When it comes to the cloud for content management, it is no longer enough for IT leads to search for capabilities alone. The digital enterprise must also consider how delivery of content management as a service can fit their particular culture. How your company formalizes business relationships and how it establishes operational processes are equally important considerations.

shutterstock_94246042Although one can view the cloud as a new technical model for delivering software, this is only partially true. It is correct that IT administrators are no longer procuring one monolithic application and installing and configuring it. Instead, they are purchasing content management functionality in incremental chunks, and ensuring these are served up safely to the right users on demand.

But the choice of cloud delivery also represents a shift in how your organization will go about its business. That’s why cloud decision-making for content management shares some characteristics with traditional application buying decisions.

Readying for Productive End Users and Rapid Deployment

In our content management domain, traditional application purchases consider how quickly end users can be trained and how rapidly content can be migrated for use by the new app. Application capabilities matter, of course, but so do the usage and Continue reading

Connectors in Pharma: A ‘Handshake’ Leads to an ‘Aha’ Moment

Lori McKellar

Lori McKellar

Director, Market Development, Life Sciences

Like everyone in IT, I like to hear about ‘aha’ moments: when solutions engineers suddenly see the path forward, break new ground, or visualize the benefits to an entire industry from a seemingly simple fix. The other day I heard about an ‘aha’ moment coming from a ‘handshake.’ 

“The firm achieved a 46% reduction in approval time for executed validation packages and a 79% reduction in production batch record turnaround time—just in the first year.”

I was chatting with Mangesh Honwad, Chairman and CEO of Delaware-based Impact Systems, an ECD partner that has been making life better for life sciences companies with a solution it calls SynapsysTM. Making life better for life sciences companies, of course, makes life better for all of us. In pharma and related enterprises, the right data at the right time means more lives are saved—not to mention that efficiently meeting regulatory requirements means saving the bottom line. But governing that data flow takes more than science. Sometimes, it takes a handshake.

Pharma HandshakeSome of the biggest IT problems these companies face are disconnects between critical data platforms, and CIOs often spend a lot of money on custom integration work. A few years ago, Impact Systems was helping a big pharma company re-engineer an existing connector between EMC Documentum and Sparta Systems’ TrackWise®  EQMS – a leading system for change, deviation, and incident management in the life sciences industry. “We created a good ‘handshake’ between the two systems” says Mangesh, “and suddenly the company was able to integrate more than 50 work processes involving a quarter million documents and records.” The firm achieved a 46% reduction in approval time for executed validation packages and a 79% reduction in production batch record turnaround time—just in the first year!

This led to the ‘aha’ moment. Surely, thought the Impact Systems folks, other companies could benefit from a similar handshake not as a custom fix, but a Continue reading

Content Access In the Cloud And On the Go – 5 Takeaways for Life Sciences

Lori McKellar

Lori McKellar

Director, Market Development, Life Sciences

Mobile and cloud technologies are primary drivers for change in Enterprise Content Management (ECM.) Workers want easy access to content from multiple devices, wherever they may be working and while on the go. Similarly, globally distributed teams are reliant on cloud-based collaboration for the exchange of ideas, decision making and keeping the business moving forward. A new AIIM report released last week looks at the current and future adoption of cloud applications and mobile access as they relate to ECM. In thinking about ECM in Life Sciences and what we’re seeing in terms of cloud and mobile adoption, there were several findings that jumped out at me. While I certainly encourage you to read the full report, I wanted to share five key takeaways from my perspective.

TAKEAWAY 1:  Assess Each Application for Cloud on its Merits

AIIM reports “16% of responding organizations are unequivocal about cloud for all core IT applications, 42% will review each application for cloud on its merits. 13% have a wait and see policy. Only 10% say “No cloud.” In a highly regulated industry such as life sciences, organizations are keenly aware of the compliance and security implications of any mission-critical application. And with the average cost to bring a drug to market totaling in
the billions, organizations can be understandably risk-averse when thinking about putting valuable, intellectual property in the cloud. Therefore, the fact that 42% of companies will review each application for cloud on its merits aligned to exactly what I’m seeing in the market. Each company has it’s own landscape of applications and systems. And, each company has its own Continue reading