In my previous blog, It’s Not About the Pill. It’s About the Patient, I asked if digital transformation was just a buzzword and if not, what did it mean? I talked about leveraging both existing and real-time information to gain insight, make better decisions, unify and speed key business processes and to engage with customers in a way that drives business value and customer loyalty.
At our recent Customer.Next event I gave customers a quick peek at the newest release of the Documentum for Life Sciences solution suite, which is now available. In this release, the four major areas of enhancements were all focused on three things – efficiency, usability and insight. Why? Because to transform, companies need to set a solid foundation for driving process efficiency, ensure that workers can easily get their jobs done and derive actionable insight to help make informed decisions, allocate resources and continuously improve. These three things are foundational “pillars” of digital transformation. Let’s take a closer look….
Pillar #1 – Driving Process Efficiency
Life Sciences organizations are tasked with maximizing efficiency across the full drug lifecycle. Bringing safe, high-quality drugs to market faster at a lower cost requires unifying processes that extend across domains, divisions and external partners. It requires the ability to link and seamlessly share documentation—the critical element inherent throughout the drug lifecycle.
Unfortunately, what we often see is organizations who are managing a myriad of disjointed systems, often gained as a result of mergers and acquisitions. Many are custom applications designed for specific departmental needs. In this situation, companies can benefit from asking themselves a couple of questions:
- Why introduce unnecessary complexity, inaccuracies and risk to business processes by exporting and importing content from one system to another?
- How do you rationalize the data models of each system to help unify processes across systems, eliminate duplicate data entry and ensure overall data accuracy and completeness?
In our new release, we are driving process efficiency in a new segment of life sciences. Many of our pharmaceutical customers also market medical devices as part of their portfolio. Yet, because of a lack of formal, regulatory requirements related to electronic submission requirements for medical devices, many of our customers were managing their medical device documentation outside of an electronic document management solution (EDMS.) The process was largely paper-based.
Therefore, to drive process efficiency, we now provide a single, cohesive solution that manages quality and regulatory documentation for both medical devices and pharmaceuticals simultaneously. With a global, standard document inventory and processes harmonized across the regulatory and manufacturing domains, we can now support the full medical device documentation lifecycle from design to production manufacturing. And because of the ability to seamlessly link and share information across domains, it helps unify and automate the process to drive efficiency, accuracy and better visibility.
Pillar #2 – Improving Usability
Another foundational pillar of digital transformation is to make it simple and straightforward for workers to access the information they need and to easily get their work done. Workers expect easy-to-use, consumer-like mobile applications that they can access on their phones and tablets to ensure that work continues even when they’re on the go. But of course, all actions must still conform to compliance requirements. To summarize, in today’s world, solutions have to be designed for people, not power users.
The first example of how the Documentum Life Sciences solution suite addresses this may cause a bit of a flashback. Why? Because I’m going to talk about controlled print. Yes, that’s right – controlled printing in the quality and manufacturing area. But controlled print has been around for ages, you say, right? It has. But that doesn’t mean something like this can’t “transform” as well. We’re continuing to meet compliance requirements but we’re doing it in a more flexible and user friendly way. Trust me; this was an unexpected hot button among our customers.
For example, wouldn’t it be easier to be able to set up a series of print profiles so that when someone needed to print a standard type of document, it automatically knows what watermarks, overlays and metadata needs to be applied? Or perhaps, the process of having to select a printer, select each recipient and print controlled copies one by one, repeating that process over and over hasn’t been “efficient” when it comes to getting the job done quickly? I don’t want to give too much away but you need to check this out.
Another improvement we’ve made to make it easier for workers is enhancing our document inventory to ensure alignment with industry/regional guidance across the globe. While we adhere to the DIA Reference Models and other industry guidance, we’ve expanded on these to ensure that our inventory supports global quality, clinical trial, and regulatory document types. Users can filter by region and select from a pre-defined list of document types to speed operations and make it simple to get the job done.
Pillar #3 – Delivering Actionable Insight
The final pillar that I’ll mention is the need to gain insight to help organizations focus resources and make quicker, better informed decisions. With Life Sciences’ ever-present goal of accelerating time to market, being able to quickly get a status or understand key metrics and trends is increasingly valuable.
Documentum Electronic Trial Master File (eTMF) was significantly enhanced to help provide insight into the clinical trial process and collection of required documentation. Granular level milestones at the country and site level reflect what TMF documentation is required, what’s missing and what’s completed based not only on the trial status but also as countries and sites progress through their individual milestones. If a site is not yet initiated, document collection requirements would not appear. Similarly, if a country has not given approval to conduct a trial, document placeholders would not appear. However, when those milestones are met, the placeholders appear. This granularity allows managers to focus on exactly what is needed at a specific point in time. And, with quick color-coding and icons, they can quickly grasp where the trouble spots are.
Similarly, new trend reporting helps identify which sites are consistently late in submitting documentation, which documents routinely fail the quality checks etc. By having tangible metrics and trend reports, companies can focus stretched resources to where the need is greatest to address the issues and boost overall efficiency and productivity.
Three Pillars and Three Questions
As I said in the beginning, digital transformation is about managing information as a strategic asset.
It’s about leveraging both existing and real-time information to gain insight, make better decisions, unify and speed key business processes and to engage with customers in a way that drives business value and customer loyalty. Efficiency, Usability and Insight are three foundational pillars that help support and drive digital transformation.
Hopefully, you also have a better understanding of how the Documentum for Life Sciences solution suite and its new enhancements can help support your transformation objectives.
Now that I’ve shared some thoughts with you, I’d like you to share some thoughts with me.
- Is there a specific process or area that your company is targeting to improve efficiency?
- What do you expect in terms of “usability?” What do descriptors like simple, easy and intuitive mean to you?
- What do you wish you could have more insight into? Are there areas where you would like more quantifiable metrics? What role are analytics playing in your organization?