On-premise software operates in a similar way. At the time of deployment you have the latest features and functions to meet your requirements. But what happens next? Requirements change, new technology becomes available and infrastructure is taxed to the limit as organisations grow. Traditional vendors will offer you a sneak peek at the next version. But unfortunately, a costly and often time-consuming upgrade stand between you and the “next great thing.”

Software-as-a-Service (SaaS) completely changes this traditional model. Instead of a depreciating asset, SaaS is an investment that will actually appreciate over time. Six months after deployment, a SaaS application will have more features and enhancements than when you purchased it, providing even more value than at the time of initial deployment. How is this possible?

• No Customer Left Behind: The SaaS model takes traditional upgrades out of the equation and instead keeps all customers on the same version. Companies no longer need to plan for major upgrades since they will always be on the latest application release at any given time. Additionally, releases are delivered at a quicker pace, as often as once every few months, providing customers immediate access to the latest and greatest functions and features rather than waiting the standard 18-24 months for the next on-premise major version.

• Vendors Focus on Progress: Since there is only one version of the application, SaaS application development teams can focus their resources on improving that application instead of spending their time supporting older, legacy versions. For example, an on-premise application on version 3 could very well need to support version 1 and 2 for an extended amount of time, in turn, exhausting resources to maintain and test older versions of the application rather than working on the newest set of functions and features.

• SaaS Infrastructure is Often Better than Yours: It’s a fact: SaaS vendors maintain or lease from world class data centers whose sole focus is keeping infrastructure online to provide outstanding application performance. Data centers maintain excess infrastructure capacity and continuous equipment upgrades to provide the best possible platform. Likewise, with all the software componentry managed by the SaaS vendor, application performance falls squarely on the vendor. Traditional answers of “Maybe your database is not tuned” or “There is probably not enough memory on your application server” simply don’t compute in SaaS.

For these reasons, SaaS customers enjoy applications that continually add business value and perform better over time, allowing them to enjoy that “new car smell” well into the future.

Eric Makovsky is the Director of Sales Consulting for Veeva Vault.

• SAS 70 Type II certification: A very strict set of controls stating that a service orgasization has been through an in-depth audit of their control objectives and control activities.
• Precise location: Unlike the public clouds a la Amazon, where it’s often a mystery as to where your content is stored, in the regulated cloud, you know exactly where your data is and where the servers are.
• Regular audits: Regulated cloud data centers are often audited by both large and small regulated companies like those in the life sciences industry.
• Strict security measures: All communication is protected by features like SSL encryption (which prevents intrusion as information travels over the network), intrusion detection at the hardware and software levels, audit trail reports, and password protection.

The added security benefits of the regulated cloud make it well-suited for life sciences companies. Not only is the regulated cloud more secure than public clouds, it also has advantages over traditional, on-premise solutions. For example, a company dedicated to providing cloud-based services will have a skilled security taskforce prepared to monitor and protect your data. On-premise data centers, on the other hand, often the resources to spend on a dedicated, around-the-clock security task forces.

Another regulated cloud benefit is data concentration. Most companies forget that the most vulnerable access points for their data are often their own people. How many times have you or someone you know sent a vital document over email or via flash drive because it was too difficult to share within a controlled system? These work-arounds may help things move faster, but it also means your content is out there, somewhere, where you have little or no control. Furthermore, misplaced or stolen laptops are crippling to a traditional user whose information is stored locally on a machine. If you operate in the regulated cloud, a misplaced or stolen laptop won’t compromise your data.

But it’s not just companies with on-premise systems that can benefit from moving to the regulated cloud; companies that currently work in a private cloud will also see an advantage. One of the most notable security advantages of the regulated cloud over a private one is that the regulated cloud provides a steady stream vital security updates. One of the easiest ways for an outsider to access a company’s data is through known holes in previous versions of software. Think about how long an update process is for a traditional on-premise or private cloud solution. There are multiple machines, compatibility issues, and data migrations to consider and plan for. Anyone who’s been involved in that process knows that that all takes significant time and effort. Now contrast that to updating a solution in the regulated cloud, where security updates are pushed immediately and with little or no effort from your organisation.

As with any vendor, companies need do their due diligence when selecting a provider. But strong regulated cloud and application services providers will empower life sciences organisations with better security, deeper collaborations, faster updates and greater capabilities than on-premise or private cloud systems. They days of dismissing cloud as ‘insecure’, ‘unregulated’ or ‘compliance challenged’ are over. The regulated cloud is here today. It is proven. And it is ready to take on the challenges of the next generation of content management needs.

Jen Goldsmith is the Vice President of Veeva Vault.

Just this past February, we were at DIA’s EDM conference announcing our new content management product, Veeva Vault. Interest continued to grow throughout the summer as we signed our first customers and began their implementations. Shortly after in October, we announced the general availability of our Vault Platform and our Vault PromoMats application, at the Loews Philadelphia Hotel. Industry friends, colleagues, and press gathered together to hear about the first end-to-end, life sciences promotional materials management application.

Our PromoMats launch was an exciting finish to a year’s hard work. To build a content management platform and application so quickly is even more impressive because it captures the end-to-end promotional materials life cycle, from concept to review to withdrawal – something that no other solution has ever been able to do. It’s a truly groundbreaking product, and will only get better with each release.

Now, as we welcome 2012, Vault has many customers in the processes of implementing, and our growing team is working to bring even more innovative capabilities to Vault.

When we began development on Vault, we were guided by three main principles: collaboration, global accessibility, and adaptability. First, we knew it was vital that life sciences companies be able to work together quickly and easily – from internal partners like CROs to external partners like ad agencies. Not surprisingly, collaboration is one of the most cited and critical benefits of Vault, according to our customers. Second, we made sure global teams could connect and develop their content in one, easy-to-use application, no matter where they are. Lastly, we wanted to provide a system that wasn’t hindered by costly and time-consuming implementations and updates, which can cripple an organisation that needs to adapt to changing regulatory and business requirements.

What we set out to accomplish back when I joined Veeva has come to fruition in a time span that’s nothing short of amazing. Due to the hard work and diligence of our team, we’re able to offer a revolutionary product life sciences companies of all sizes can enjoy.

This year, things will only get more exciting. We will be releasing new Vault applications, creating innovative new Vault features and growing our teams to support our ever-expanding customer base. I hope that you will continue to follow us as we blaze the regulated content management trail.

Jen Goldsmith is the Vice President of Veeva Vault.

But do the systems that life sciences companies use to manage their regulated content help teams work together efficiently and cost-effectively? Here are five clues that your company’s content management systems are not collaborative:

1. You have to set up separate sites for each type of collaboration. One collaboration site would be manageable, maybe two. But for life sciences companies, the number of complexity of collaboration mechanisms is a lot higher. Setting up and maintaining these separate mechanisms is often difficult to manage, especially for emerging biotechs who don’t have the means to maintain multiple systems.

2. In the last 30 days, someone in your organisation has emailed you a submission-related document. Despite the high compliance risk, this is too often a route many users take because they need a way to complete a task faster than their content management system accommodates it. The challenge with this is that there is no way to track or control what happens to the content once it leaves the system, opening the door for a multitude of potential compliance-related issues.

3. You need a separate software user license for each external collaborator. This can get expensive for large life sciences companies, and growing biotechs can’t be saddled with the headache of making sure they have enough user licenses available. This is especially painful when working with external users who only need access for a short period of time.

4. You need to send a laptop, VPN token to your external collaborators. In the Internet age, where you can share your personal photos with family across the world, or access your extensive music collection in a few clicks, there should be no need to access documents via a mailed laptop or custom VPN token. Collaborative, yet controlled, access to content should be no more difficult than accessing your secure email online.

5. Adding a new external collaborator into your system is measured in days, weeks, or months. It’s perfectly normal for a clinical study to stretch across months and even years, but taking that long to just add an external collaborator? Absurd, especially if you need those external collaborators during the clinical study process. By the time they’re added, the study may already be complete.

If any of these sound like things you do, you are stuck in the classic life sciences collaboration conundrum – how to collaborate quickly and easily in a compliance driven environment. For more information on this topic, see our white paper – Collaboration Conundrum: How to Share Content in Today’s Global Life Sciences Industry.

Do you find collaboration easier said than done at your company? How does your company collaborate?

During an action-packed morning, our director of sales consulting, Eric Makovsky, walked us through a live demonstration of the end-to-end promotional materials process in PromoMats. From creation, to review, to approval, proofing, distribution and withdraw, Eric showed us how easy it is to manage the full promotional piece life cycle, collaborate with external vendors and partners, and make changes to the PromoMats application.

In addition, one of our early customers presented on their experience implementing PromoMats, focusing on how Veeva’s end-to-end solution, life sciences business process knowledge, and attentiveness to their company’s needs were critical in selecting and implementing Vault. It was a great opportunity for attendees to hear first-hand about a PromoMats implementation and ask questions about our customer’s project as well as future plans for Vault.

In just over a year, we brought an innovative new product to our life sciences customers and, in doing so, brought regulated content management to the cloud. This could not have been done without the hard work of our dedicated team and our customer’s strong belief that regulated content management does not need to be hard, it just needs to work. With General Availability of the Vault product just a few days behind us, one thing remains clear: it is time for content management revolution! Veeva Vault is here, and many more wonderful things are to come.

1) Get Back to Basics – First, take a step backwards and determine what is really necessary to improve how we find, manage, and use content today. For years, we added on bells and whistles that were seldom used, often broken, and difficult to maintain. Lesson learned: if it doesn’t help find a document more quickly, manage or share that content more easily, or allow organisations to adapt more rapidly to changing business and regulatory requirements, then it shouldn’t be done.

2) Collaborate in the Cloud – Remember when collaborating on content meant walking down the hall to meet with the team? Today we collaborate across teams, across organisations and across the world. Therefore, we need better, faster, and more secure ways of sharing information without the cost and overhead associated with VPNs, dedicated laptops, and other means of getting vendors and partners behind the firewall. How do we do this? Move to the regulated
cloud. For some time now, organisations have used the cloud to share everything from sensitive financial documentation to biomedical research. The result? Better collaboration that can be set up in minutes, not days, weeks, or even months.

3) For Goodness’ Sake, Make it Easy – When was the last time you heard a document management user exclaim, “I love my 3-day training course on searching!” or “Woo hoo, folder navigation refresher training is next week!” Yes, it’s probably been a while. So why do we still need intense training, 600-page user manuals, and other support mechanisms for our current systems when doing things like ordering a book on Amazon.com or searching with Google is so easy? It’s not that the latter processes are so much simpler; in fact, consumer website processes are actually more complex. It’s that most current document management systems were designed pre-consumer web and are thus often incompatible with a modern user’s behavior. Leveraging the commonly understood and well-proven design and functionality from the consumer web can make systems dramatically easier to use and maintain. In other words, no more 3-day training or 600-page manuals – just log in and go.

4) Take Back Your IT! – Stop installing, upgrading, optimising, normalising, and managing things that fall into the category of “DMS upkeep” instead of “DMS value.”  Life sciences organisations can get better performance, better functionality, and a more robust infrastructure by leveraging new content management capabilities through the cloud. Removing the burden of maintaining servers, installing updates, and managing upgrades lets IT departments focus on bringing new innovation and capabilities to their end user communities instead of just struggling to “keep the lights on.”
Change is coming to life sciences content management, and the landscape will look dramatically different in 5 years than it does today. Maintaining the status quo is no longer an option. Digital information is an asset that keeps growing in both volume and complexity. However, volume and complexity do not have to equal systems that are difficult to use or maintain. So simplify, collaborate, take advantage of the next generation of content management technologies, and turn your Document Hunters back into information producers.

Wow. In fact, double wow with a little jaw dropping. Not only was this answer focused on some pretty basic stuff, it was, startlingly, the same basic stuff I heard from people 15 years ago when the first of these Electronic Document Management (EDM) systems started going in. So, what happened?

1) Companies lost sight of the basics – With all the bells and whistles available for document management systems today, companies seem to have often lost sight of the basics. For example, users may have the ability to run an enterprise search engine across multiple data and document sources, but if the results are meaningless or too broad, they are useless. And this is just one example; there are many more, from intricate taxonomies, to integrations and technical architectures so complex that they are nearly impossible to maintain.

2) Processes became more collaborative and global, but systems did not – The past 5 years have seen tremendous change in the way the life sciences industry works. More than ever, companies are creating collaborative networks across organisations and across the globe. However, document management technologies continue to remain siloed and stuck behind a corporate firewall so thick that the only way to work together with others outside the organisation is to duplicate, email and find other ways of sharing information.  This practice, while well intentioned, only adds to the difficulty of finding and managing information.

3) We let the word “Enterprise” = “Complex” instead of “Collaborative” – Some of the best and most useful technologies are also the simplest to use. Think Google, Facebook, Amazon, Netflix, Snapfish and other consumer-facing technologies that have taken activities far more complex than finding a document and made them easy for even the most novice of technology users.

4) Technology became a barrier, not an enabler – When did this happen? 15 years ago, document management technologies made submissions production times shorter, publishing easier, and document review and approval better. At what point did this same enabling technology grow so complex that we started hearing things like “I can’t get the report finished because the system isn’t working”; “I can’t find anything in my document management system”; and “I can’t share that document with you because I can’t give you access to our systems”? Ask a document management end-user if their technology is helping or hindering them, and you will most likely get a resigned (and resounding) sighhhhhhhhhh.

So where do we go from here? How do we make sure that document management system users have the tools they need to work effectively? How do we return to a model of technology enablers and not technology barriers?

I’ll be sharing some thoughts on these questions in our next blog post. In the meantime, I welcome your comments on your own challenges using EDM systems.

Jen Goldsmith is the Vice President of Veeva Vault. Contact her at 
jen.goldsmith@veevasystems.com

Real SaaS, or Software-as-a-Service, leverages the cloud to deploy applications over the internet. With SaaS, a provider licenses an application to customers as a service on demand, through a subscription or a “pay-as-you-grow” model. While customers achieve significant economies of scale by sharing the infrastructure and application, they can still create their own look and feel to the application and securely manage their own data. Using true Software-as-a-Service is much like living in an apartment building. You share all of the infrastructure – elevators, security, landscaping – but if you want bamboo and stainless steel and your neighbour wants pink shag carpet and lava lamps, you can both have what you want. The benefits of SaaS are huge: in short, SaaS-based solutions are better, faster, and cheaper than their onsite or hosted counterparts.

To clear up some confusion about SaaS-based solutions, we’ve come up with three signs that your “SaaS” is not what you thought it was (for more on this, see our whitepaper, SaaS Knockoffs: Wolves in SaaS Clothing).

1. Your application can be installed onsite. If a vendor tells you that their SaaS solution can be installed onsite, run far, far away. Onsite SaaS is completely illogical. Here’s why: for a solution to be SaaS-based, the infrastructure and application have to be shared. If the system is onsite, it’s only being used by you; others can’t share it. In the end, you lose the economies of scale that lower costs and increase flexibility and quality – a big advantage of SaaS.

2. Sure, we support multiple versions. One of the best things about true SaaS is that everyone is always on the same version. This means that you never have to worry about when your application is going to “go out of support.” Additionally, application vendors can devote all those resources that used to support old versions of the software to developing new and better functionality for you, the customer.

3. There’s only one upgrade a year. With a SaaS-based solution, you should expect anywhere from 2-4 upgrades each year. Because everyone shares one instance of the application, it’s easier to offer multiple upgrades.
Have you seen the term “SaaS” used to describe things that aren’t really SaaS? Let us know in the comments below.

When the Vault team first came together, we all felt a bit like that kid with a blank piece of paper in front of us. Our first attempts at designing the user interface and interaction for our cloud-based regulated CMS were pretty much the same formula we had seen over and over – folder pane on the left, document grid in the middle of the page, action menu across the top –the green grass, sun, and flowers equivalent of a CMS. Then we took a step back. We realised just how much we, as users, were conditioned to accept the formulas set by mediocre enterprise systems.

Away from the office we wondered why we could quickly find the perfect item on Amazon in a few clicks, but never find our documents without wading through a sea of unreliable search results. Or how it was so easy to update our Facebook status but so difficult to create a new document. Or how we could share a video of our child’s first birthday with the world on YouTube, but struggle to share a clinical study protocol with a Clinical Research Organization (CRO) that we’d worked with for years. We realised that these consumer sites – Amazon, Facebook, and YouTube, to name a few – understood user behaviour. Content management systems, on the other hand, didn’t. The tried-and-true formula that so many CMS providers built just didn’t support the modern user. The consumer web works because it’s easy and intuitive. We needed to incorporate that kind of ease into a controlled and regulated content management system.

So we broke out our crayons and started to draw something completely new. Much like our classmates that started drawing freehand, we started sketching out a new approach to content management. We scoured websites for inspiration – sites with lots of data, files, and images (finally a way to leverage my online shopping prowess at work!). On these sites we were able to filter and refine any field of results in a few clicks and quickly find what we were looking for. So for Vault, we made simple and accurate search, filtering, and easy document retrieval key design focuses. We knew we were on to something when we heard companies of all sizes talk about the importance of “find-ability” over and over again at the DIA EDM conference in February.

Join us as we throw away the clunky systems – those that find nothing of value, require meaningless attributes, and are a pain to use. Stop using technology that does not work and start using something that makes sense!

We invite you to have a look at the Vault Demo of the Week to get a sneak peek at the next great step in life sciences content management. And keep checking back to see what’s new with the content management revolution!

But what happens to content once it has been approved? How is it used? Where can you find it? And how do you bring that content back or retire it? Too often the answer is “I don’t know” or “We could find out, but it would take days, weeks or even months.” Knowing where your content is and how it’s being used is especially important for life sciences content, and the benefits of doing this right can be tremendous: searches that take minutes, not days or weeks; greater control over market messaging; and the ability to update content quickly and accurately.

Below are three tips for better regulated document tracking practices:

• Begin with the end in mind – Make sure you know how your content will ultimately be used. For example, if there is content in a manufacturing technical report that will be used in a CMC regulatory report and, ultimately, in multiple global submissions, know that from the outset. Understanding how content will be used will help you avoid rework, duplicate copies, and other common content pitfalls.

• Know Thy Document Distribution – I’ve worked with companies that have devoted substantial time and resources to manually track down content once it has been distributed. Organisations need to find distributed content for multiple reasons. For example, you may need to find a promotional piece because the health authority has asked you to remove it from circulation. On the R&D side of the house, you may need to find where a particular document has been submitted so that when it is updated, regulatory can easily understand the impact on submissions to health authorities across the globe. Tracking the distribution of content once it is approved can save countless hours of trial and error search and recall, as well as reduce the cost associated with maintaining document content.

• Find a System with a View – An end to end view, that is. Too often, our view of the content lifecycle is segmented. We go to one system to view the planning information, another to understand the development of the content, and a third (or more) to understand how the content is being used. This model of managing content can lead to duplicate content, version mismatches, and other content management nightmares. To avoid these, make sure your systems have the ability to view content status and use from concept or planning to development all the way to delivery and retirement.

Join the conversation! What are some tips and tricks you’ve used to enhance your document tracking practices? Please share them in the comments below.