Even in highly-regulated industries like Life Sciences, accessing key systems via the cloud, on a software-as-a-service (SaaS) basis, is rapidly becoming the default as consumer-based habits around everyday application use extend to the workplace. But what are the key considerations, and how do you choose a provider? Here are 5 common topics to focus on.

Businesses used to view cloud-based software and data hosting, along with subscription-based delivery (e.g., Software-as-a-Service, or SaaS, delivery models) with considerable caution. Concerns about risk to business continuity in the case of network or data center downtime; fears of supplier lock-in or security breaches; and questions about long-term cost of ownership seemed to undermine the promise of simplified IT management; improved speed of deployment; and more flexible access to systems and data beyond the office.
Today, cloud and SaaS-based system delivery is not only proven; it is fast becoming the norm. And this extends to strictly-regulated industries too, including Life Sciences.

The technology has matured considerably; networks/connections and backup provision are altogether more robust; service provider offerings have become incredibly sophisticated to appeal to corporate buyers; and the pace of technology advancement has accelerated to the point that the alternative – buying software and running and managing it on premise – no longer makes business sense in the majority of use cases.

As digital-native generations enter the workforce, and as employees generally become familiar and comfortable with using the cloud to store photos and documents in their personal lives via their smartphones and other devices, the appetite for cloud-based application access is growing too. The perception of risk associated with externally-hosted applications has greatly decreased, especially as built-in cloud security becomes increasingly sophisticated.

Despite users’ increasing comfort level when it comes to relying on hosted solutions in their day-to-day lives, there are some important considerations when deciding to move a business process to a cloud/SaaS platform.

Below are some of the considerations for business functions when making decisions related to cloud-based SaaS deployment:

1. Integration options

Although there is a general belief that cloud-based software makes it easier to connect and exchange data between applications, this isn’t a given. While it is possible to connect platforms through application programming interface (API) calls (a message sent to a server asking for information), those applications may not have an intensive library of calls, depending on the level of development investment the supplier is willing to make. Additionally, there can be barriers to implementing integrations like sharing security protocols or opening firewall ports where multiple suppliers are required to coordinate/cooperate with each other to enable the requested functionality.

2. Validation

In regulated industries like Life Sciences, software must be shown to be reliable in delivering what’s expected and to support patient safety, product quality, and data integrity. That means conducting risk-based testing and compiling as well as maintaining documentation proving that the software functions as designed and required.

In a cloud-deployed SaaS context, many software providers will include access to their validation package, even if there is a modest associated fee to access the associated scripts and documentation. In this context, the challenge of cloud-SaaS is the software functionality is subject to regular updates throughout the year, with customers largely at their mercy. Each update will require an impact assessment to identify any changes that will need to be made to existing configurations, as well as understanding new configurations that the business may wish to implement. Along with these changes, some level of validation will be needed, which requires involvement from internal teams.

The advice here is to:

• Refrain from too much customization. Stay close to the out-of-the-box functionality, wherever possible. Choosing the best fit initially will help considerably here.
• Check out the validation provisions ahead of time to avoid resourcing issues later.

It’s worth looking into associated documentation and training, too, as this can help users get up and running quickly and confidently using the new software. Best-case scenarios can be within a couple of months compared to 12-18 months for an on-premise deployment.

3. The risk appetite of the relevant business function

With so much security and trust built into cloud/SaaS services now, decisions about whether to embrace externally-hosted/subscription-based software access comes down largely to the risk appetite of the given business function. Often, the advantages substantially outweigh any negatives–reduced reliance on internal IT help and support, and faster access to the latest technology features are among the bigger pluses of choosing the cloud/SaaS route. Again, it is vital to perform an assessment of the preferred SaaS provider. It’s also a good idea to check whether your peers are among their customers, as this will provide useful clues to the supplier’s credentials in your sector.

4. Licensing/pricing and scalability models

One of the great appeals of accessing software through a SaaS model is the ability to spread costs, and to scale capacity with the needs of the business. But it’s important to examine the overall cost of ownership over time. Be sure to check the terms and conditions around price increases and clauses related to scaled demand. Many SaaS models offer tiered pricing depending on the role, where a read-only account has a different cost compared to an account that can create and edit content. So be sure to plan for the number of users you will need as well as the specific roles each user would require.

5. Ongoing support

This is something we’ll cover in a separate blog, but it’s important to at least mention here the importance of assessing what is provided for in the way of post ‘go-live’ support. Also, what that might look like in reality if you actually have to use it (something you can’t know in advance).
Direct vendor support might be fairly rudimentary, but there may be a certified partner that can bridge any gaps and provide a more tailored service that fulfils the business’s requirements.

Learn more

To find out about fme’s comprehensive SaaS consulting, implementation and support services, including our platform-assist offering, please contact us and and we’ll schedule a time to discuss your specific requirements.

Related

• Ensuring a stable SaaS implementation

In today’s fast-paced digital world, businesses need to stay on top of their technology game. However, managing business applications can be a challenging task, especially for small and medium-sized businesses (SMBs) that have limited resources to maintain an in-house IT team for specialized business platforms. Below are some of the challenges, and how fme PlatformAssist™ provides the solution.

Challenge 1: Aligning business needs with vendor releases

With the introduction of cloud-native or SaaS applications, companies struggle to stay on top of vendor releases and effectively manage application updates that are pushed automatically. If you are “lucky” you have some flexibility to schedule based on your internal timelines, but that’s not always the case. However, it happens, someone needs to assess the impact of the updates to the business functionality and process, and someone needs to complete the validation. Unfortunately, it is not uncommon for team availability, experience, and knowledge to not be in sync with vendor schedules. Teams facing a large amount of other “Priority 1” items risk overlooking important considerations for the rollout of the new release or are unable to realize its full potential as they juggle and prioritize critical deadlines. We’ve seen many over-burdened businesses miss out on important improvements.

This is where external support like fme’s PlatformAssist™ can help. Our team is experienced in reviewing and assessing releases for impact, and are able to scale up to implement the update as the releases are published. We identify the musts and maybes (in Veeva lingo – auto-on and auto-off) and hold them side-by-side to business functionalities to clarify impact to current process and functionalities. We then highlight valuable improvements that can provide clear benefits. Next, we help with any resulting configuration and (validation) documentation updates and make sure the release update process runs smoothly and turns into a “non-event”.

Challenge 2: Keeping pace with your evolving business

While being buried in day-to-day business and vendor release management it is easy to forget about evolving business needs. As a business uses their business applications every day, it is expected that they will find areas for improvement and enhancement. Whether there are flows and pages that can be streamlined to the actual use, or additional documents and processes that should be included, your team will make improvement requests which will need to be properly captured and followed up on. When we’ve started working with many clients, we could see the capturing process working, but a majority of improvement requests get eternally deprioritized or forgotten over time. This leads to frustrations between IT and the business team.

fme’s PlatformAssist™ addresses this gap and the management of the backlog of requests. We can assess each request, identify the technical impact and necessary implementation steps and efforts, prioritize them based on business input, and align them to releases on the business roadmap. This can all then be coordinated with upcoming vendor releases and other platform maintenance activities. From technical solution design, to implementation, rollout and (validation) documentation, we make sure that each business application release is treated as a mini project and gets proper attention. With this organized approach, the business benefits from the continuous improvement of the application, and the team is able to work more effectively and efficiently.

Challenge 3: Day-to-day business issues

Besides planned release and application updates happening multiple times per year, every company has unplanned IT application issues and needs every day. Some are caused by the system, and a few may or may not be caused by the users. Either way, they still need to be corrected so the team can get back to doing their jobs to make the company successful. In most SMB firms, the IT team supports a wide range of technology across multiple integration points. The team has to juggle conflicting priorities as their focus shifts from business applications to other important tasks on their plate. In a perfect world, everyone would be trained on every solution and understand how they all work together. The reality is somewhat different. We frequently work with very talented teams where:

• Older solutions on legacy platforms are maintained by long-time staff who carry the major knowledge of the application. Newer staff aren’t as familiar with the details or unique configurations.
• Newer solutions have been added that the entire team is not sufficiently familiar with yet. Many companies opt for ‘train-the-trainer’ onboarding programs, but then struggle to make time to disseminate the knowledge to the full team.
• Integration points between applications require additional knowledge to ensure they work together, and not all workflows, configurations and integrations are documented in line with ‘the way things actually work.’
• Important team members have left the organization, leaving a substantial gap in institutional knowledge.

Neither SMB nor enterprise firms have the IT budget they need to have enough experts on-staff to eliminate all of these challenges. These issues inevitably combine to create frustrating situations where resolutions are delayed because immediate challenges fall outside the “sweet spot” of the available support team members.

In a growing business with modern solutions, these types of delays happen more frequently than they need to. An essential question to ask is “Is the quality of your support services provided by your internal team living up to yours and the business’ expectations?” It should not be asked critically, but with the goal of ensuring that the business needs of the company are being met effectively and economically. You should be able to leverage your technology to help achieve your business goals, not be crippled by it as you struggle to maintain and increase the ROI of your investment.

With many of our clients, fme helps fill the knowledge gap with our PlatformAssist™ services. We provide an experienced team of experts to address their day-to-day business challenges in an efficient process that scales as needs require. Many of our clients take advantage of this service after new solutions go live and they are still in the onboarding cycle. This allows the team to complete their training in the new platform while having solution support available to solve more complex challenges.

From our experience, bringing in flexible, external specialist support allows for better control of costs and support outcomes, and allows internal teams to refocus on critical tasks beyond the standard support issues, direct business questions, and required daily administrative tasks. Our global team is trained across a wide-variety of business application platforms, and can support your business 24×7 with existing Documentum and Sparta Trackwise applications, as well as with Cloud-native applications such as Generis CARA, Veeva Vault and Sparta TWD.

fme PlatformAssist™ is scalable and agile

Every company goes through the above challenges, and must face them in a way that aligns with their business goals and limitations. Tailoring our services to our clients’ needs is our top priority. Our offerings are modular, and components such as release and demand management can be added or removed as needed. We understand that needs might vary between platforms and clients, but also might fluctuate within the course of a year depending on vendor releases or critical business activities. Together with our clients we keep a close eye on current versus upcoming needs, and scale our team size up and down as needed to accommodate the specific skillsets and resource needs expected for upcoming activities. Clients appreciate our agility and flexibility, our long-term client relationships are proof of that.

Learn more about fme PlatformAssist™

Do you have full control over the post-implementation activities for your business applications? Is the business happy and satisfied with the support that they are receiving? Not just for immediate issues, but also for processing releases and backlog items? fme’s PlatformAssist™ can help. Our team will be happy to review your current processes, platforms and challenges with you and identify potential areas where we can help you work more effectively, efficiently and economically.

Contact us today to learn more about fme’s PlatformAssist™. It’s a cost-effective solution to manage modern IT challenges with the business factor in mind.

Applying Life Sciences best practices for business success

Today, competitive life sciences companies are looking to transform their everyday operational processes. Through strategic use of modern technology, their goal and absolute requirement to stay competitive is to manage workloads more efficiently and consistently for better business outcomes. In these complex businesses, it’s critical to approach this transformation from both the technology perspective as well as the holistic business perspective. This holistic view can make a profound difference to project outcomes, delivering the most business impact and ROI on technology investments.

Twelve years of experience working with clients on exactly this potential has provided fme consultants with a unique ability to help here. We understand the business processes and know first-hand how all the technology fits together to provide optimal workflows and solutions. Our experience goes beyond immediate critical areas like Regulatory Affairs, and extends across different business units to amplify the value of complex data, documents, and information.

Here’s a brief overview of one of our typical engagements. Read the information below and contact us for more details, and to discuss your current challenges.

Long term relationships for long term success

We first connected with one of our long-term clients over a decade ago. As a successful international pharmaceutical firm, they had many divisions and business units integrated through a complex network of systems, servers and silos that shared, shuffled and sorted a plethora of data and documents around the globe. The scope of our initial technical engagement was to maintain servers and associated processes, which we were able to provide quite well.

As we worked together on this first engagement, the fme team was able to get a deeper understanding of the content, tasks, goals, and strategies that were being used across different business units. Our goal wasn’t myopically focused on deploying systems, or even the larger task of integrating them and migrating data from legacy environments. Based on our extensive industry experience, we took a holistic view, discerning how those systems could be used more efficiently. We saw how their information was being applied throughout the company, and presented a range of opportunities to streamline and simplify the way those tasks were being completed day to day. Our client was overwhelmed with our initiative, and opened up several more projects. In one instance, we were able to reconfigure a system so users around the world can log onto a controlled environment and fill out the relevant training information in just a few minutes, without any to-ing and fro-ing of queries. Processes that once took 30 minutes or more per request can now be completed via self-service in a fraction of that time.

With successes like these, our relationship quickly expanded and evolved with many additional business units. We’ve been able to improve in areas ranging from the generation of reports and overviews, and the digitalization of manual processes, to the reinvention of training and associated administration, and much more. In another recent project, we analyzed business processes and assessed the scope for digital transformation using the Microsoft Power Platform, including the central recording of data around business documentation and training. Our peak projects there have seen us field 15-20 technical consultants globally, plus two on the business side, providing a seamless interface between the business departments and the technical teams.

Today, we continue to be a prominent digital partner, continuing to help streamline daily activities as well as plan and execute larger long-term initiatives.

fme is the company you love to work with

The reason clients like this love to work with fme is our unique experience and insights from successful digital transformations in a wide range of companies and industries. In addition, the rapport we build with our clients is pivotal. We’re open, approachable, and visible to the business and technical teams we work with, and they feel comfortable talking to us. The client team knows that if they are under-resourced/have particular knowledge gaps, we’re ready to step in. Where required, we can take over as a project lead or manager too, overseeing the interconnections between different processes and the scope for higher-level thinking.

We have a broad spectrum of knowledge, and can always find the answer to a challenge even if that resolution if outside of the current project. We’re specialists not just in system implementation and content migration, but also in how to transport legacy processes to a new digital set-up, where workloads can be refined and optimized. Our engagements span quality management, standard operating procedure (SOP) management, regulated/submissions documents, clinical trial administration, and training SOPs, and more.

If you’re struggling to progress your own digital transformation ambitions, why not have a coffee with us and we can talk through the various ways we might be able to help?

For more information, please complete this contact form and we’ll schedule a time to discuss your specific requirements.