Pre-plan Your Regulatory Transformation Projects for 2024

Pre-plan Your Regulatory Transformation Projects for 2024

From building a realistic AI roadmap to making better choices about technology partners and broadening the impact of RIM systems, fme’s consulting approach and specialist data services can help pharma, biotech, and medical devices companies maximize investment into their digital transformation journey – both now and in the future.

It can be hard to effectively prioritize an ambitious digital transformation journey when external requirements and technology-based systems keep evolving. In a Life Sciences Regulatory context, those moveable parameters include changes dictated by compliance with IDMP data standards, or unique device identification (UDI) in the case of medical device manufacturers. Other influences might take the form of company mergers or acquisitions that require system consolidation or data harmonization, taking advantage of the continuous changes in evolving technology, or new opportunities to transform processes linked to the Regulatory functionality.

To successfully prioritize next steps and set realistic budgets that align with business goals, it’s important to consider the overall digitalization and transformation company roadmap.

We suggest reviewing these 3 considerations in particular when firming up plans for 2024.

Your roadmap for AI

Everyone is talking about artificial intelligence (AI) and machine learning (ML) as the technology becomes more advanced and accessible for mainstream day to day use. Certainly, it carries enormous potential to save time and drive new process efficiency, consistency, and repeatability. But there are use cases that lend themselves to AI/ML-based transformation, and others that do not, and it’s important to have a clear understanding of both the opportunities and the potential risks.

For instance, Generative AI (assistants like ChatGPT) could be ideal for drawing up job descriptions, summarizing recent achievements for a report or blog article, and/or improving communication across your organization (e.g. keeping everybody up to speed with the progress of a Regulatory Information Management implementation project). But such tools could incur substantial risk if used to generate patient information leaflets.

fme’s technology and content specialists can help you develop an appropriate strategy for your AI journey. Also, we can help you evaluate the current technology landscape – e.g. Regulatory Information Management (RIM) providers or other content management providers.

Get more out of your RIM system

Investing in a RIM system is a strategic move for organizations, with its significance extending beyond the immediate regulatory function. The true value of RIM platforms emerges when they transcend mere content collation and agency submission management.

The potency and transformative impact of a RIM platform become apparent when it delivers rich and comprehensive knowledge, making it accessible across the entire organization. When Regulatory, Quality, and Safety information is holistically stored and managed, strategic teams gain the ability to construct a nuanced understanding of market trends, identify adverse events, and pinpoint gaps in market coverage.

Elevating visibility beyond individual silos is a game-changer, providing C-level executives with a holistic view of organizational dynamics. This comprehensive perspective empowers executives to make informed decisions swiftly, expediting the process of bringing products to market.

Realizing the broader benefits of a RIM platform necessitates the formulation of a clear yet flexible digitization roadmap. Building on a sound data ‘bedrock’ is critical, establishing the right infrastructure and software platform to support smart, digitized information use and process efficiency. This foundation enables strategic compliance with evolving regulations and creates room for targeted adoption of AI and other technological advancements, ensuring the system’s relevance and value for at least the next five years.

Whether the strategic goal involves improved high-level decision support or leveraging Generative AI for routine, low-risk content creation, trust is paramount. Professionals must have confidence in the validity, quality, currency, completeness, and consistency of the information harnessed from the RIM system to effectively drive organizational goals.

Understand what you need from your RIM system and technology partner

Every RIM and content management solution, and technology partner, has its own features and benefits, and selecting the right fit will depend on the size and complexity of your organization as well as your future business goals.

Consider the following: As a pharma company, you don’t produce all the chemicals and machinery that go into the production of a drug. You select and assemble the best components to produce and deliver your product in the most cost-effective way. It’s the same for your technology solutions and partners. Should you expect a single vendor to provide a complete end-to-end solution that amazingly fits your unique needs when procuring a technology platform? No. It’s far more effective to define your requirements, and find technology and partners with their own capabilities, strengths, and experience that aligns with your needs, and all the vendors to concentrate on delivering a solution that is compliant with all regulatory requirements. Your technology vendor shouldn’t have to provide data assessment and migration services, a unique set of skills that are available from skilled specialists.

It’s critical to evaluate potential new technology and partners and understand what qualities you need in the full scope of the project including initial business process and data analysis, implementation and integration, data migration, and post-implementation support. Many decision-makers are swayed by a vendor that appears to offer a full end-to-end solution and services that seem to be packaged with all the associated services. But if those services are all designed around that company’s own product, how can they be sure they’re getting unbiased advice for a futureproof investment? That is an exceptional level of trust for such a large and business critical investment.

Instead of choosing a platform provider based on the promise of an end-to-end service, strategic companies choose knowledgeable and certified technology partners that are 100% focused on their unique business challenges and vision.

As an independent service provider, fme doesn’t have a vested interest in recommending any particular RIM or content management vendor or platform. fme’s consultative approach, specialist data services, and proven tools are designed to optimize the selection, delivery, and output of the system of choice. With proven strategies, fme helps companies navigate the complex minefield of vendors and technology options. Not only do we clarify and define your unique requirements, we have extensive experience with all the leading RIM platforms, along with deep insights into where these fit best relative to the type and size of the organization and its specific priorities. We help companies select and implement solutions that fit their needs in the short- and long-term, solving today’s challenges, manage and maintain those solutions as they grow, and establish a pathway for continual improvement as technology evolves.


Whatever your digitization objectives, fme’s business, technology, and content experts can help you assess and maximize the ROI of your plans. Whether you are planning a stand-alone project or incorporating an initiative within the context of other ongoing projects, fme can help you align your business strategy, technology, and priorities with your available resources, as well as platform vendors’ respective product roadmaps.

To discuss or analyze a current RIM project or transformation requirement, contact us. We’d love to learn your challenges and provide an independent perspective designed to amplify your business success.

Update: Critical dates for OpenText Documentum solutions entering maintenance mode

Update: Critical dates for OpenText Documentum solutions entering maintenance mode

On September 1st, OpenText made an important announcement regarding the product versions that will transition into “sustaining maintenance” as of September 1, 2024. (Read January 2023 list here.) Given that many organizations are now gearing up for their 2024 Budget & Planning phase, this presents an excellent opportunity to align your strategic initiatives and future plans with the changing landscape of OpenText products. It’s time to assess your options: do you stick with your current systems and opt for an upgrade, or do you take this moment to break free from inertia and explore ways to streamline and modernize your infrastructure, aiming for increased agility, performance, and return on investment (ROI) from your IT spending?

Solutions entering maintenance mode 

Here is a selection of important dates, as well as OpenText’s upgrade recommendations.

Selected previously announced items expiring December 2023

OpenText Documentum D2 16.5 → CE 22.4
OpenText Documentum D2 Advanced Publishing Services 16.5 → CE 22.4
OpenText Documentum for Capital Projects 16.4 → CE 22.4
OpenText Documentum D2 +Pack 16.5 → CE 22.4

Expiring May 2024

OpenText™ Documentum™ eTMF Solution 16.6 -> CE 22.3
OpenText™ Documentum™ Quality and Manufacturing Solution 16.6 -> CE 22.3
OpenText™ Documentum™ Research and Development 16.6 -> CE 22.3
OpenText™ Documentum™ Submission Store and View 16.6 -> CE 22.3

Expiring September 2024

OpenText™ Documentum™ Administrator 16.7 -> CE 23.2
OpenText™ Documentum™ Branch Office Caching Services 16.7 -> CE 23.2
OpenText™ Documentum™ Composer 16.7 -> CE 23.2
OpenText™ Documentum™ Content Storage Services 16.7 -> CE 21.3
OpenText™ Documentum™ Foundation Classes 16.7 -> CE 23.2
OpenText™ Documentum™ Foundation Services 16.7 -> CE 23.2
OpenText™ Documentum™ High-Volume Server 16.7 -> CE 21.3
OpenText™ Documentum™ Reports 16.7 -> CE 22.4
OpenText™ Documentum™ REST Services 16.7 -> CE 23.2
OpenText™ Documentum™ Server 16.7 -> CE 23.2
OpenText™ Documentum™ Trusted Content Services 16.7 -> CE 21.3

Newly announced items expiring December 2024

OpenText™ Documentum™ Administrator 16.7 → CE 23.2
OpenText™ Documentum™ Branch Office Caching Services 16.7 → CE 23.2
OpenText™ Documentum™ Composer 16.7 → CE 23.2
OpenText™ Documentum™ Content Storage Services 16.7 → CE 21.3
OpenText™ Documentum™ Foundation Classes 16.7 → CE 23.2
OpenText™ Documentum™ Foundation Services 16.7 → CE 23.2
OpenText™ Documentum™ High-Volume Server 16.7 → CE 21.3
OpenText™ Documentum™ Reports 16.7 → CE 22.4
OpenText™ Documentum™ REST Services 16.7 → CE 23.2
OpenText™ Documentum™ Server 16.7 → CE 23.2
OpenText™ Documentum™ Trusted Content Services 16.7 → CE 21.3
OpenText™ Extended ECM for SAP® Solutions 16.2.10 → CE 22.4
OpenText™ Extended ECM for SAP® SuccessFactors® 16.2.10 → CE 22.4
OpenText™ Extended ECM Platform 16.2.10 → CE 22.4

Opportunity for improvement 

Use these expiration dates as a way to encourage new decisions and actions to improve, augment, or upgrade existing solutions. This is a good time to review current infrastructure and identify opportunities for effective streamlining and modernization to achieve new agility, performance, and ROI from IT spending. 

Commonly addressed frustrations reported by fme clients include: 

  • Upgrading to latest system versions to take advantage of fixes, improvements and enhancements; 
  • Replacing underlying OS or database versions (for example exchanging Oracle with PostGres or similar); 
  • Migration to/system consolidation on the latest/cloud-based version of a current platform; 
  • Implementing new and modern desktop and mobile user interfaces that will truly engage end users working on-site and in remote locations; 
  • Strategic content archiving designed to free up capacity, reduce costs and boost system performance of core, critical business systems; 
  • Retiring legacy systems altogether and starting over with a new application. 

Here’s a practical plan

First step: Understand your current state 

Begin by gaining a comprehensive understanding of your current systems, including which solutions will be affected by these changes, their interconnections, and their significance to your business processes and workflows. We recommend conducting a thorough review and analysis of your existing technology ecosystem to define and prioritize your environment, identify potential risks, and explore various solution options. As a trusted partner in OpenText and Documentum implementation, fme offers specialized workshops that can guide you through this process and provide a range of options for your next steps. Armed with this knowledge, you can evaluate emerging opportunities and unmet technological or business needs.

Next: Plan for the future 

An in-depth analysis is crucial – perform a comprehensive IT health check before committing significant resources to your initiatives. Some companies delay IT investments for as long as possible, often at the risk of higher long-term costs, increased potential for risks, and greater internal resource consumption for ongoing maintenance. Many find that a strategic investment now can prevent future issues and ensure their systems meet future requirements. Others may opt for a larger initiative to reap the benefits of new solutions ahead of their competition. Regardless of your chosen path, keep in mind that implementing the new setup and migrating designated content may take several months. Hence, early awareness and informed decision-making are essential for a smooth transition.

Now: Engage the experts 

fme is uniquely positioned to assist companies in evaluating and navigating the forthcoming OpenText Documentum upgrades. We have a longstanding partnership with these companies and possess expertise across all associated platforms. Our credentials include:

  • Over 100 experienced Documentum consultants 
  • Over 1,200 person-years of Documentum project experience 
  • Multiple Industry awards: Documentum Partner of the Year, EMC Top Service Partner, OpenText Technology Partner, OpenText ECD Silver Partner, OpenText Partner of the Year Finalist, DELL/EMC Partner Innovation Award, Rising Star Award Finalist, and more. 

Moreover, fme is a pioneer in the industry with our proprietary platform solution, migration-center. This solution is designed for highly automated, large-volume migrations, ensuring minimal downtime during complex migration scenarios. It empowers our customers to reduce costs, mitigate risks, enhance productivity, and expedite the go-live of enterprise content management (ECM) applications.

We offer comprehensive solutions 

We offer a full suite of end-to-end services to solve your current and future challenges. With our talented and experienced team of experts we can: 

  • Execute discovery and roadmap workshops  
  • Analyze existing IT estate and identify improvement opportunities 
  • Implement or update systems and solutions  
  • Integrate data silos across systems 
  • Migrate complex data and content
  • Provide ongoing support, whether on-premises or in the cloud

For more details about our approach to ensuring your success, please visit:

No matter the scope of your OpenText Documentum-related projects, consider letting us assist you by lightening the load and ensuring a successful transition. Your journey to a more agile and efficient IT environment begins here.

Complete the contact form below and we’ll schedule a time to discuss how we can help you eliminate your challenges, increase your IT ROI, and decrease your system TCO. 

Structured content authoring is transforming drug approvals processes

Structured content authoring is transforming drug approvals processes

Guest post by fme partner Maarten van Vulpen, Customer Success Manager, Fonto

In this dynamic, digital era – and in the context of expedited drug approvals processes, post pandemic – continued reliance on static, single-use Word documents to capture and publish or exchange critical information with Regulatory agencies makes no sense. It is hampering productivity, efficiency, compliance and visibility. Fortunately, there is a better way. Structured content authoring is already transforming drug approvals processes in Life Sciences.

In other industries, including the precision engineering and manufacturing-based automotive and aerospace industries, the automatic re-use of approved, structured content assets (fragments of approved text) is well established. Automatically generating onward documentation from a single source of approved content truth is the key to accuracy, reliability, and traceability as well as process efficiency.

And now Life Sciences, as it undergoes digital transformation, is beginning to recognize and reap equivalent benefits of structured content authoring (SCA) and automated content re-use, with a powerful impact on internal process efficiency.

There’s a practical imperative to this, too. In a bid to accelerate the approval of important drugs and make their own processes more efficient, health agencies are become more digital and dynamic in their information management and exchanges – an expectation they are passing on to drug manufacturers and license holders.

Yet, as long as these companies persist with Word/Excel/PDF based information and content management, they will only be creating more work for themselves in their efforts to keep up with those changing demands.

Driving new value from existing information with structured content

Pharma companies are already rich in regulated product information. The challenge is that much of this exists within single-purpose documents, dotted around different systems across the organization. This means that for each new purpose, teams have to go through protracted and laborious processes to locate, piece together, and seek approval for each new document use case – whether they’re generating a study report, submitting a new marketing authorization application, registering a product change, or updating labelling.

Structured content authoring tools like Fonto Editor strike right at the heart of this situation, transforming the way pharma subject matter experts (eg Clinical Trials, Regulatory, Quality or Safety teams) collate, publish, and manage vital drug information right across the product development, registration, and marketing lifecycle. Crucially, they are able to do this without having to brief out the content creation to technical writers, then check and approve their output. That’s because the SCA solution is intuitive for users, offering them a very familiar, Word-like experience, while building from content dynamic, reusable digital content assets.

Although there isn’t yet a single, agreed standard or schema for how documents should be constructed across Life Sciences globally, this will come in time and companies will be able to adapt to this relatively easily. That’s as long as they have got to grips with structured content authoring – and the immense scope for more reliable, efficient, and repeatable use of regulated information across a wide range of applications.

Transformation from the core

An obvious place to start in the adoption of SCA in pharma is the core data sheet, a key document representing the pharmaceutical company’s position on – and the definitive, correct, and current truth about – a product.

Once the core data sheet’s contents have been structured and stored as a series of digital content fragments, they can be flowed into a whole host of other documents including submission applications, reports, labels, and clinician/patient information, without risk of manual error – or the need for new rounds of internal content checks.

One of the top 5 pharma companies globally has already seen a 15% increase in productivity in processes linked to drug approvals, since adopting Fonto Editor to more automatically generate content that sails through internal checks.

By combining both Fonto and fme’s knowledge and experience with advanced ECM solutions, pharma professionals get several benefits. First, Fonto shields them from having to understand the ins and outs of XML formatting – a substantial win and time saver. Second, teams from across the drug lifecycle can gain seamless access to SCA capabilities from within their existing regulatory information management (RIM) platforms as a natural extension of their everyday work.

fme & Fonto: a formidable SCA partnership in Life Sciences

fme and Fonto share a strong pedigree in transforming Life Sciences content and data management, working together to integrate and embed SCA within companies’ Veeva, OpenText Documentum, or Generis CARA, or other systems. This means that relevant functional teams can shift to structured content management and authoring without having to learn to use new, separate tools.

For more details on structured content, Fonto has presented, and continues to present courses on the potential for structured content in Life Sciences via the Drug Information Association (DIA) – here’s a link to a recent session.



As the Life Sciences industry grows more serious about digital process transformation, fme has been highlighting the potential of SCA, too. In this post from fme’s Manuela Bernhardt, she explain that “Data is the heart of the business, whereas documents are the ‘packaging’ to create context”.



A dynamic pharma future needs structure

Over time, the opportunities for transforming content management processes through re-use of approved digital assets with at least some degree of automation will only grow. The regulators, as well as competitive market pressures, will demand it; meanwhile technology vendors like Veeva will continue to pave the way for powerful content re-use, as long as this is planned properly (for instance, with the support of RIM vendors like Veeva delivered through specialist Life Sciences partners like fme and Fonto).

To find out more about the potential for structured content authoring and management in your own organization, download this data sheet covering fme and Fonto offerings.

Click here to learn more about Fonto’s partnership with fme.

Or contact us to start the discussion today!

About the author

Maarten van Vulpen is customer success manager at Fonto, the leading solution in structured content authoring. This role gives Maarten the opportunity to discuss structured content authoring, its advantages and innovation with customers and potential customers from multiple industries, including life sciences. 

Ensuring a stable SaaS implementation: 3 things to consider

Ensuring a stable SaaS implementation: 3 things to consider

In this second blog on optimizing cloud-based software deployments in highly regulated industries such as Life Sciences, we consider the critical decisions linked to the rollout itself, as well as ongoing support, and the kinds of provisions that are too easily neglected.

Opting to deploy or switch to a SaaS-based software solution is a decision process all of its own, as discussed in a recent post by Alicia Whitney. But the considerations don’t stop with choosing the cloud route or a particular software provider. It’s just as important to make sure that related service and support requirements are addressed, particularly in a regulated industry such as Life Sciences.

Every SaaS solution has to be built on a strong foundation – certain standards must be met, and validation maintained – to ensure that business processes play out as they should, and that all associated data retains its integrity and dependability over time.

Here are three of the more critical decisions relating to the actual implementation and ongoing support:

1. The time & budget allowed for implementation of the cloud-based software

Although externally-hosted platforms and applications are generally much quicker to deploy than their on-premise equivalents, rollouts still take time because of the preparation work involved to move data across and check that everything is as it should be.

It can take a minimum of three months to switch on a cloud-based system, and potentially a lot longer for a large company with high volumes of data. That’s not least because of the data checks and cleanups required to ensure the new software delivers and can be relied upon.

As the old adage goes, if you feed garbage into a new system, you’ll get garbage out – however advanced the software might be. When preparing a migration to a new SaaS platform, it is critical to include an assessment of the existing data or content, and evaluate how much cleansing and enrichment needs to take place before that information can be confidently migrated to and used reliably within the new environment.

Someone will need to make this assessment and advise on the next steps, which is likely to mean engaging a qualified and suitably experienced independent third party. This will need to be someone who knows both the industry sector and its particular demands, as well as the source and target software platforms or systems involved.

It is far better to understand the need for this assessment ahead of time. Ignoring this process and reacting after the project starts often causes panic, delays the go-live, and ends up costing a lot more.

2. Who will advise on & provide the necessary support

As the subject matter expert or ‘system owner’, unless you appoint someone, internal or external, to look after support and release considerations, your company will be at the mercy of the software vendor’s schedule for next releases, feature updates, and you will need to manage and resolve any issues this fixed schedule might create. The software vendor may provide initial implementation and configuration advice, but the documentation for subsequent releases is intended for a wider audience of their entire customer base. It certainly won’t be tailored to the specific considerations and validation needs of your organization.

Although it is a positive that providers are continuously enhancing the functionality of their cloud-based platforms and applications, every update can present new configuration decisions which in turn may have a bearing on software validation and business process. These incremental releases can happen several times a year, each with possible implications for workflow or data functionalities. You may be able to choose which features you turn on as a new release is issued, but having someone outside of the vendor company who can assess what’s involved and help make a judgement call will be invaluable – especially for a small company that lacks this capability in house.

3. Service-level agreements (SLAs)/statements of work, and more

Not all third parties/vendor service partners are alike, so it’s important to research what you’ll be getting in the way of independent advice and support as you embrace a new cloud-based/SaaS solution.

Elements to consider when evaluating different service providers include:

  • Their relevant industry and associated business process knowledge (e.g. in Life Sciences, or other regulated sectors)
  • Their breadth of platform/software-related capabilities
  • The quality and granularity of their service-level agreements (SLAs) or statements of work

Ask, too, where the service provider’s capabilities, services begin and end – can they deal with the data assessment, preparation/enrichment, migration, and post-go-live support? And can they help you plan or refine your timeline and budget so that this is realistic?


It’s easy to be lulled into the belief that the cloud/SaaS option is the quicker, easier, smoother solution because the hardware, security, and scalability provisions in an externally-hosted solution are no longer your concern. And honestly this is often true. It is also true that long-term solution success can be attributed to equally valuable tasks of: upfront assessment and preparation, a smooth deployment and implementation, an effective content migration, and skilled platform maintenance. These are all elements fme helps pharma and biotech companies with every day. We’d love to help you as well.

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

Join fme in Boston at the Veeva Summit: R&D and Quality

Join fme in Boston at the Veeva Summit: R&D and Quality

fme has been selected as a Gold Sponsor for the Veeva Summit: R&D and Quality for Boston this September, and we are looking forward to sharing our experience and strategies with the Veeva community. We enjoyed June’s European summit in Madrid, and are honored to be recognized in an elite group of certified partners invited to participate in the North American event.

We’d love for you to join us to explore how to leverage the power of the Veeva platform to achieve your business goals.

Join fme at the Veeva Summit!

fme specializes in the end-to-end implementation, integration, and support of the Veeva platform. At the summit our team of experts will be answering questions, discussing our capabilities, and proving how our partnership can guide organizations to new heights of efficiency and productivity. We will also be highlighting our newest offerings that deliver exceptional benefit to our Veeva clients:

  • fme PlatformAssist™ – A comprehensive set of modular building blocks that provide you with the unique end-to-end services needed for carefree post go-live management of your Veeva platform.
  • dqMan for Veeva Vault – Modeled after our popular dqMan for Documentum, our new version is focused on the specific requirements of Veeva clients, eliminating time-consuming and repetitive tasks and making admin and data management easy.
    If you are attending the summit, contact us and let’s set up a time to meet so you can get the most value from the summit.

If you are attending the summit, contact us and let’s set up a time to meet so you can get the most value while we’re there together.

Contact us to learn more

fme delivers the end-to-end knowledge and support you need to maximize the value of the Veeva platform. We’d love the opportunity to share our experience on how to best configure, utilize, and support Veeva for the unique challenges of your organization.

Contact us to schedule a personalized presentation aligned with your unique challenges. To schedule a discovery meeting with fme’s Veeva experts, reach out to our Global Sales Director René Rosenberg at

Key topics for Life Science companies considering SaaS solutions

Key topics for Life Science companies considering SaaS solutions

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.