AWS Sumerian as Quality Training – Digital Learning in the Enterprise

AWS Sumerian as Quality Training – Digital Learning in the Enterprise

Digital learning is an exciting and at the same time very dynamic area where technologies are constantly evolving. There is an increasing need for companies to integrate this new way of learning into the corporate culture and overall business strategy in order to leverage its efficiency gains.

Increasing digitization is changing the way we live, work and study today and in the future. Without the use of digital media, lifelong and true-to-life education is hardly conceivable. When it comes to professional learning, in particular, digital media offer new opportunities. They convey content quickly, effectively and on-demand.

Learning on paper

Let’s have a look at a simple example from the pharmaceutical industry: digital transformation of manufacturing processes is a top priority for many companies today. On the way to a digital company, you have to think about manufacturing software, networking of components and systems in a highly integrated IT architecture. The current learning standard is still based on the analogue learning method “on paper”. Although innovation progresses rapidly around them, the employees have to laboriously work through inanimate information to understand equipment, processes or infrastructure systems. Many of these themes are so extensively profound and highly complex that they fill entire bookshelves.

 

learning using lmsLearning using LMS

On the way to the digitization of the pharmaceutical industry, the introduction of learning management systems (LMS in short) appeared as an initial solution. Originally established to deliver compliance training to the right people and ultimately to document the completion of training, today’s focus is more on the learning experience and sharing of knowledge. As a “benefit”, it allowed employees to access any learning content at any time – not just during a training course. Even though they didn’t bring about a great innovative change for the individual employee (digital learning methods), the LMS is at present the cornerstone for future learning.

 

learning by autoring programsLearning by Authoring Program

The introduction of special “e-learning” programs and software for authors, which supported the learning management systems, brought about a change in the learning methods for employees: apart from the pure paper / text method, training became now enriched with simple language, animations and interactions. This enables the learner to experience a heightened sense of being involved in the training.

 

vr-brilleLearning by Virtual & Interaction Training

The next step is now to allow the learning staff to immerse themselves in the training interactively or virtually. “Experience learning” with digital learning methods, such as Virtual Reality (VR) and Augmented Reality (AR) solutions, can actively engage learners for rapid learning, customer loyalty, and decision making. These technologies allow employees to experience learning content rather than merely read it.
Ultimately, all industries face the same problem: they need to bring professional knowledge to life more efficiently and cost-effectively. Training is costly to businesses because it reduces working time and resources while trying to improve or maintain quality. It is crucial, however, that – on the way to Pharma 4.0 – not only do systems and equipment get modernized but also staff gets better training.

 

digital_learning

A cost-effective way to create AR / VR applications is Amazon Web Services with the Amazon Sumerian solution. Scenes can be created which involve new employees more actively during onboarding. It is possible to model a training environment for teaching or to simulate real-life scenarios. Similarly, an application for troubleshooting and repairing common problems could be created or in “digital-healthcare” an animated visualization of the brain, spine, or heart, which is explained by a host and explored by the learner. The applications are many and varied.

Ultimately, you can let your imagination run wild to create not only a comprehensive but also a very appealing, virtual coaching experience. Additional equipment or complex virtual reality platform management is not required. It is also possible to create realistic virtual environments and scenes without having to purchase special tools for 3D modeling, animation, lighting, audio editing, or programming.

In this context, professional-quality, realistic scenes can be created quickly and easily using an integrated AWS Sumerian Web-based editor.
You can easily generate high-quality Virtual Reality (VR), Augmented Reality (AR), and 3D applications with a range of tools. There is no need for deeper programming or 3D graphics knowledge.
The finished creation is provided cross-platform. There is no need to write custom code or deal with specialized delivery systems and processes. The scenes are published as a static website that you can load directly into any compatible browser or embed in your website.
You are supported by a visual script tool. This intuitively supports defining a flow logic to allow objects and characters (so-called Sumerian hosts) to react to user actions and thus control Amazon Sumerian behavior.

In so-called “state machines”, each object is assigned an action and these are then managed in an overarching collection of states. The current state of the application may then switch between the predefined states based on user interactions, timing, or other events.
Each state in an object consists of one or more actions, each containing a logic defined by Amazon Sumerian. For example, an active state action may cause a user to click an object that executes a script. Another action may be to record a voice sequence that is sent to an Amazon Lex chat bot or interacts with other AWS services.

To create realistic and unique learning experiences, Amazon Sumerian also offers a catalog of ready-made objects. Users can access this detailed library to create VR environments. You can then view them with any hardware that supports the WebVR and WebGL platforms. They are also not restricted to the platform’s catalog because they can also use third-party material libraries. In addition, objects created on the platform can be imported.

On top of that, the platform also uses the Amazon Polly and Amazon Lex technologies, as well as other services from Amazon. Polly allows you to convert text to speech. It is essentially an AI that uses deep learning to replicate human speech patterns. The end result is a lifelike voice. Lex has similar text-to-speech capabilities. However, conversation interfaces can also be created here. In the Amazon Sumerian context, Lex lets you create voice-activated commands for a learning module.

My journey through Life Sciences

My journey through Life Sciences

Within these years of learning, I was established in the company’s IT department and made some excursions to purchasing, sales and production control departments.

I was taught that IT links everything in a company together. Each department has their own specific IT requirements, used software tools and tasks to fulfil. Obviously and in many areas, it was very easy to see that business and IT folks did not speak the same language.

Some of my IT colleagues preferred to stay in their IT silo than exchanging with business. Unfortunately, there were many prejudices between the two camps.

Studies are over, and now…

 When I passed my exam, I spent some months in the classical IT helpdesk department, which has expanded my experience with people, tools and associated difficulties. It was a great opportunity to get insights from different departments and to connect with a lot of people.

Afterwards, I moved into the R&D (Research & Development) department. Here I served as an interface between IT and this specific business area and learned a lot again:

  • Many scientists and physicians worked here, everyone unique with a special character, vita and behaviour
  • Clinical trial documentation was mainly available as paper file
  • Semi-professional CRF design
  • A flood of forms
  • SOP management on paper base with enormous effort to update, distribute and teach people. Especially the mandatory and regular trainings were extremely boring
  • Paper driven SAE management
  • Siloed solutions for labelling, shipment and tracking of trial medication and much more

Luckily, my boss there was very curious, open-minded and interested in new trends and developments. This caused the introduction of a document management system within our ‘Klifo’ department to replace paper-based clinical trial documentation by an electronic solution including forms management. Again, I learned much about how to take hurdles, changing the classical way of working, needs for communication.

Sadly, the way was very hard, as many of the old-established staff did not see any sense to move onto an electronic document management system. They argued they could grab directly into the paper files located on the shelf behind their workplace.

 

 

My Life Sciences continuance

After a short break and working for a Consulting company with focus on other industries, my Life Sciences way continued in another Life Sciences oriented company. At the (my) beginning, the company sold pure statistical data on pharmaceutical products used for marketing and trend analysis. By the time and after various acquisitions and mergers businesses expanded to provide complete solutions to our clients focused primarily on Phase I-IV clinical trials, associated laboratory and analytical services, including consulting services.

I was part of the global service delivery team where we developed, hosted and supported an analytical software system to analyze pharma marketing, medical and promotional data. Furthermore, we took care of the regular data delivery for various pharmaceutical companies and supported solutions for performance reporting & analytics, Data Management and Business Intelligence.

For myself, this involves working extremely globally (from client perspective as well as internally). It broadens my spectrum of different cultures, thinking, behavior and communication. Even at my location, around 10 nationalities were represented. It was required to be and think flexible and open-minded for new solutions. Very interesting, with new challenges every day.

fme AG: Back to Document Management

 A decade later joining the Life Science division of fme AG, I felt like coming back to my roots. Coming back to document management systems (which are nowadays completely different from 20 years before) but difficulties between business and IT continues.

I had a kind of déjà vu when I started a new project recently for a German pharma company and needed to pick up my office key. The way from the main gate to the building, seeing the truck scale and the key transfer process implied NOTHING HAD really CHANGED. Nevertheless, in fact many things have changed.

At this point, I want to encourage anyone to have a look into fme Life Sciences portfolio.

fme is the ideal partner for Life Science companies to implement, improve and strengthen processes around document management systems (Reading example: Case study – Dr. Pfleger Homogenous DMS Infrastructure
Based On OpenText Documentum).

I’m curious about how my journey will continue…

Keep Talking: Why Communication Is the Key to a Successful Project

Keep Talking: Why Communication Is the Key to a Successful Project

When an investment in IT solutions doesn’t live up to expectations, this can often be attributed to lack of effective communications and the establishment of a formalized communication plan. If the project is pushed through the various phases before the teams discuss shared expectations, what each phase includes, and the potential issues and anomalies that could potentially arise during each phase, the project has a high probability that it will go off the rails at some point.

To ensure successful project outcomes, project leaders must be good communicators. In fact, the Project Management Institute says the biggest part of any project manager’s job, consuming 90 percent of their time, is communicating.

Institutionalizing communications

  • Set clear objectives A successful communication plan should begin with clear objectives, milestones, expectations and even escalation paths should something go wrong. The rules of the road should be discussed and agreed to with the key stakeholders on both the client and vendor partner side. While it may seem obvious, it’s important to set up a clear and regular line of communication so team members can report project progress.
  • Develop lines of communication Project leaders can’t be responsible for every aspect of the project, so it’s important to delegate tasks and set up clear lines of communication so team members can quickly and easily report back on what has been accomplished, what’s outstanding, and where problems have arisen. And always share changes to any part of the project with all team members..
  • Establish a regular cadence for meetings Regular meetings are important to allow project risks to be identified and talked about. But since projects and teams are often dispersed across departments and even geographies, it’s of paramount importance to find a variety of ways to communicate effectively and to establish effective lines of communication that can help the project move along fluidly.

A Closer Look: Client Learnings

Let’s take a closer look at what can happen when communications are not part of the project plan from the start.

In a recent client project, we were moving swiftly from phase to phase in implementing a new system. The client’s project team had an aggressive timetable, and while we were aligned on the tasks for each phase, inevitably stakeholders would be asking questions at the end of each development cycle that indicated to us the proper communications was not established from the onset. It was clear that some key decisions or clarifications were taken by functional leads that didn’t take into account other regions or users of the future system.

Were they made aware how the schedule impacted them? Did they understand changes in processes? It was clear they weren’t.

We were able to leverage our experience and lead the client through an exercise to understand the impact on other regions/sites and the broader implications for their processes. While solidifying needs and requirements at the midway point of the project would impact the timeline and overall budget, the client understood the criticality in getting regional leads involved in the decision-making process and fully aligned on the complexity of the project and its potential impact to their functions.

This one decision allowed us to get back on track and guarantee all users’ needs were addressed while ensuring the broader goals and objectives of the organization were being met as well. Having clear communications and more inclusive processes helped them avoid further unexpected starts and stops to the project, but more importantly, ensured greater success for user acceptance post implementation. The client appreciated fme’s expert guidance, ultimately helping them avoid any further costly changes and delays.

 fme’s 8 communication tips for a successful project

  1. At the start of the project, develop a communication plan that maps to the overall project plan and incorporates triggers on when and how to communicate with stakeholders.
  2. Reach understanding, agreement or consensus about pivotal decisions that could impact processes, schedule or stakeholders’ day-to-day job.
  3. Manage stakeholder and project team expectations. A key part of communications is understanding the requirements and expectations of stakeholders so they’re “on board” with the changes that need to happen.
  4. Ensure there is a smooth delegation or handoff of tasks by documenting roles, responsibilities and accountability.
  5. Identify potential project risks and the communication channels and escalation required to minimize those risks.
  6. Develop effective methods to report project progress, looking for opportunities to communicate in person or via regular virtual meetings so there is regular and ongoing communication about the project.
  7. Track progress and let all stakeholders know where the project stands, particularly important as project deliverables or milestones shift.
  8. Create communication channels to quickly share changes with team members as they arise. For example > SharePoint is one of many tools to store weekly status reports as well as meeting minutes and action items.

When good and ongoing communication is built into a project, problems can quickly be addressed and the stress of failure can be alleviated.

Veeva R&D Summit Puts Focus on Innovation and Best Practices

Veeva R&D Summit Puts Focus on Innovation and Best Practices

As a Veeva Migration Services partner, fme was a key sponsor of the summit and we were excited to be part of this growing industry event. During both days of the summit, sessions were separated into tracks: clinical operations, clinical data management, quality and manufacturing, regulatory, the Vault platform and innovation theatres. A total of approximately 400 life sciences companies attended and 61 spoke at the summit.

One of the newer Veeva Vault initiatives is Vault RIM and Veeva has been proactive at making product enhancements based on customer feedback. A key part of moving to RIM is data migration, which is often a complex and time-consuming process. Ultimately, the time spent on the migration is worth the effort since a centralized RIM capability, such as Veeva RIM, is a game-changer for companies.

Moving to a shared data model

A common challenge for many companies is managing product changes, or variations, after receiving approvals, because information is typically not in one place. Veeva and fme client Vertex spoke at the summit about the benefits of having a shared data model within a unified RIM platform. Not only was there a business benefit to this approach but it also helped to align with their objectives of meeting their commitments to patients. Pharma giant GlaxoSmithKline also spoke at the regulatory session about their journey toward unifying regulatory processes and how Vault RIM is helping them to integrate teams in different countries. The ability to simplify deployment and streamline implementation will also be key to ensuring pharmaceutical companies meet their RIM objectives.

Clinical Data Management

Another key track was clinical data management, with a session focused on building and running complex trials using advances in monitoring, cleaning and reporting data. Integral to this is the migration and management of safety data. As companies begin their transition to a more integrated approach to clinical data, they will need to consider their safety data migration fully and carefully.

It was also great to recognize and celebrate Veeva Heroes, which honors six industry pioneers who over the year have gone above and beyond to help move the industry forward. These innovators have pushed boundaries and navigated change at their company to improve processes and deliver outcomes. This year’s innovators included: Jennifer Trundle, Gilead Sciences; Joe Brenner, Johnson & Johnson; Lisa Little-Tranter, Lilly; Michelle Harrison, Vertex Pharmaceuticals; Sandra Freeman, Johnson & Johnson; and Shelly Plapp, Melinta Therapeutics, Inc. Congratulations to everyone.

The Veeva Vault Summit continues to grow and attract increasingly large numbers of life sciences companies that are eager to learn more about areas integral to their business. In fact, the summit has become so large that during this year’s keynote speech organizers had to use an overflow room to accommodate the audience. Next year’s session, which will be held in Boston, will undoubtedly take these large audiences into account.

In addition to joining the 2020 Veeva R&D Summits in both the US and Europe in our capacity as a partner, fme is also planning to sponsor the Medical Device & Diagnostics Summit to be held in Minneapolis in June 2020. Hope to see you there!

Updates from the OpenText Enterprise World Conference in Toronto

Updates from the OpenText Enterprise World Conference in Toronto

On top of that, there are additional challenges as a result of mergers and acquisitions. Once they come together, companies are forced to consolidate documents and data from different systems and sources. Further, there is high pressure to reduce the on-premise footprints of enterprise applications – and with that, maintenance and personnel costs.

So, it’s always good to keep on top of these trends and get the latest solutions available to respond to these changing dynamics. We were happy to join the OpenText Enterprise World Conference in Toronto earlier in July to hear the latest news.

We were out in force with our product, services and sales teams meeting clients at our booth and with our technical staff joining the variety of sessions and labs as much as they could manage. Overall, the conference provided a good overview of the status and roadmaps of the components of the OpenText and Documentum product suite.

In case you missed the meeting or were looking for the latest updates, here are some of the highlights from this year’s conference:

  • For the Documentum platform, it is good to see that there are improvements and enhancements happening across the platform. Cloud is of course one of the big drivers, and all components are on the path to support containerization to allow for easier deployment and management in cloud environments.
  • Documentum Cloud Edition is the next generation from OpenText and will be available in April 2020. It can run anywhere – off or on cloud – and there will be no need to worry about upgrades again.
  • On the InfoArchive side, the latest version offers connectivity to Azure Blob storage to store archive storage (unstructured content and more) for lowest cost of ownership, and the next versions will continue to support more cloud storages like Google Cloud storage, NetApp Storage Grid, and AWS Storage.

 

Working primarily on front-end topics I was especially interested in the following:Working primarily on front-end topics I was especially interested in the following:

  • Good news – Webtop will not disappear just yet. Though it will just be maintained, there is no end-of-life announced at this point. While it is not the client of future, this will at least buy a bit more time for clients to decide which direction to go for their future user interface. Main clients for Documentum remain as before – D2 for content-centric applications and xCP for process-centric applications. An integration or merge is not planned at this point.
  • In addition, the D2 SmartUI has come into play. The goal is to come up with a (close-to) unified user interface across the OpenText applications – Content Server and Documentum. It should simplify the access to the stored documents as well as provide easy access to integrated systems. For D2, it uses a big part of the D2 Configurations. It also will be the base for the mobile app to provide access from devices.

Another big topic at the meeting was the extension of some of the advanced OpenText features to the Documentum platform. One of them is the SAP integration with the Extended ECM Adaptor for SAP. Also, this integration can be exposed for end users through the Smart UI.

Working heavily with customers in the life sciences industry, I was of course eager to find out what is planned there as well.

  • On the Documentum front-end side, the Documentum for Life Sciences suite will remain the major front end. The cloud-based Life Sciences Express client uses the same D2 configurations and is planned to replace the Classic UI more and more in future, additional features are still being added there to turn it into a full-feature client. The goal is to provide an easy-to-use but feature-rich client that will run as a regular web application but will also allow mobile device users to efficiently work with the application.So far, the application is focused on read-only use cases but there is a plan to extend it with the required document management capabilities. Some glimpse of that could be caught during the Innovation Lab – and it looked very promising.The classic Documentum Life Sciences suite will still be extended and enhanced, but pure user interface and usability improvements are being targeted for the LS Express client only moving forward. Further business-process-specific cloud applications are planned to enhance the client portfolio. The Quality CAPA application had been published before and was enhanced some more, and a new Regulatory Planning application is in the queue now and is targeted to be developed in close interaction with interested customers.

Finally, on the innovation front, the other big topic was – of course – the use of artificial intelligence (AI). During the keynote sessions, it was noted that all companies should now consider themselves “information companies,” making it important to find ways to put information into business context. Whether to comply with regulations or to create efficiencies to accelerate time-to-market, AI technologies can be leveraged.

 

All in all, the conference provided several opportunities for clients to connect and exchange experiences. Thanks a lot for the interesting conference (and for the “Paws for the Break” – such cute puppies) and I’m looking forward to seeing everyone next year in Vegas!

Checklist for a Successful OpenText Documentum D2 Implementation

Checklist for a Successful OpenText Documentum D2 Implementation

After all, the sheer volume of content can be overwhelming and the potential to change business processes that developed over time can be a contentious point in any organization. This planning checklist can assist in making the transition as painless as possible and put your organization one step ahead in planning and implementation.

1. Know your workflow processes, but be adaptable
While Competent Authorities have specific requirements around the development, manufacture, and maintenance of drug products, drug substances, and medical devices, the specific business processes to meet those requirements are not explicitly defined by the Authorities.Companies generally develop processes to comply with the requirements and still provide an efficient flow to ensure the product/device can be supplied to the market. While your business processes may have been developed specifically for your company, certain efficiencies can be gained by broadening requirements and adopting the best-practice solution provided by OpenText. By adopting a future state business workflow that aligns with the best-practice models supplied, you can take a smarter and faster approach to your implementation, allowing your implementation partner to focus on other, higher-value customizations that will benefit your business.

2. Familiarize yourself with the DIA reference model
The Quality & Manufacturing solution has been developed with the DIA reference model as its backbone. This industry-supported model outlines an organizational structure for documentation. OpenText Documentum for Life Sciences Quality & Manufacturing module leverages this model to provide an out-of-the-box solution that can manage 95 percent of your documentation. You can derive maximum value from this model by identifying artifacts that closely align with current documentation and by adopting the DIA terminology. If necessary, additional artifacts can be added in the Quality & Manufacturing solution with consideration for validation and documentation effects.

3. Define templates
Content creation is the function of your authors. Using templates for the content ensures uniformity across the solution and makes your review team more efficient, allowing them to focus on continuity of content, rather than on formatting. OpenText Documentum for Life Sciences Quality & Manufacturing module provides the ability to associate templates with each artifact name, if desired. Templates that are imported into the system must be approved before use in content creation, allowing control over the formatting and structure of content authored in the system.

4. Know your users’ roles and functions
OpenText Documentum for Life Sciences Quality & Manufacturing module provides a site-based, role-based security model to save time and effort in determining how to set up security. The combination of membership in site and role allows the business to limit access to content, as needed while permitting appropriate individuals to perform certain business functions. Roles provided by the solution include author, reviewer, approver, quality organization approver, coordinator, and administrator. By identifying the users who fit these business roles early on in implementation, you can accelerate the system set up and provide very focused communication and process training to the impacted roles.

5. Identify your system champions
Implementing OpenText Documentum for Life Sciences is a significant change, whether moving from a paper process, a previous Documentum system, other software system, or even a previous version of the solution. The best approach to building positive momentum is to identify a small group of users who will learn the system first and act as change-makers and champions of the new system. This will go a long way to support the overall user adoption. Of course, user training is paramount to system adoption and a positive impression of the system’s capabilities. Beyond that, a core group of champions for the software can initiate a wave of excitement for the new system. Change in any large organization can be challenging, but change combined with a learning curve presents two significant hurdles. By anticipating the challenges and preparing your processes and people in advance, organizations can positively promote change and work through many of the challenges presented by those learning curves.