Digital transformation is about more than technology

Digital transformation is about more than technology

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.

Best Partner for RIM and Digital Transformation

Best Partner for RIM and Digital Transformation

An extension of your IT team: whenever you need our specialist expertise

Whether you’re a sizeable pharma organization, or a more modest biotech or medical device company, it’s likely that your IT ambitions have grown over recent months. That might be due to a regulatory information system (RIM) implementation or upgrade, or a drive to make data work harder for the wider enterprise.

Certainly, we are seeing updated regulations (such as IDMP and MDR), and a growing emphasis on data generally, translating into more advanced digital transformation initiatives. In many cases, these next-level projects will encompass more than one departmental function and set of integrated IT systems. That’s to ensure that data is unified and consistent right across the organization and its regulatory touch points.

The good news is that fme’s extensive, highly skilled, and deeply experienced Life Sciences technical team is on hand to help.

Our 360-degree perspective is unique

We’re unique in our ability to combine detailed knowledge of all of the major technology platforms with extensive knowledge of digital transformation best practice across Life Sciences.

Deep cross-platform expertise

We’re deeply skilled in integrating, migrating, and enabling the reliable exchange of data across all of the major platforms used in Life Sciences. These range from leading platforms like Veeva, Sparta, Generis CARA, and Documentum, to all of the popular manufacturing information systems, accounting/resource management systems (like SAP), chemical systems, health & safety systems, and more.

Across any combination of these platforms, we can help with all of the following:

  • Strategic project planning/roadmapping
  • Application integration
  • Data transformation/conversion & migration
  • Data integration
  • Data validation
  • Experience in complex regulated industries

Even more importantly, we have an unparalleled understanding of the opportunities for amplifying the ROI of complex systems as well as the technical challenges and regulations facing the Life Sciences industry today. This combination of skills gives us a unique perspective for helping companies across the sector realize the benefits of technology efficiently and effectively.

In addition to our in-depth knowledge of the critical success factors of data-driven transformation in the pharma, biotech and medical device sectors, we also bring to bear best practices from other global industries that face similar strict regulations, yet are more advanced in their IT-based solutions. fme manages and supports technical projects across the automotive, chemical, energy, and food industries, supporting and guiding these clients throughout their strategic technical plans and in the practicalities of their integration and data migration initiatives. The rich experience in these additional diverse challenges has allowed us to distill and refine the most effective methodologies to apply strategically in more effective solutions for our Life Sciences clients.

End-to-end services

As an optimally-sized firm, fme has the agility to deliver services from small to large scale. Our global presence is perfectly positioned to provide best-shore teams from our locations across the US, Europe, and India. Sometimes, our clients only need an additional specialist to supplement their own internal IT resources. As they take on new and ambitious system upgrades, consolidations or fuller digital transformation projects, fme efficiently scales resources to match their increasing requirements. This unique technology partnership capability allows us to provide end-to-end services that match our clients’ needs.

Business consulting

If you’re not sure where to start, or are having trouble translating data ambitions into tangible projects and timelines, we can definitely help. This includes building the business case for projects that are often overlooked and difficult to coordinate cross-departmental justification and budgets.

Technology, data, and migration services

As well as becoming more efficient and data driven, most companies are looking to streamline their complex IT estates with the goal of bringing down the total cost of ownership, reduce duplication of effort, and increasing confidence in data as a dependable source of enterprise and regulatory intelligence. The Holy Grail of most data-related projects today is to create a single, connected source of truth: entering data once, and utilizing accurately across all use cases. fme has unparalleled experience in each of these areas, connecting business processes, data and documents in an integrated solution aligned with business goals.

We can also serve as strategic project managers, implementation partners, or at a much earlier stage as consultants and project designers. Our technical subject matter experts can fill specific gaps in capability, or we can do it all – all the while bringing industry and parallel sector experience to bear to maximize project success.

Managed services

We can also support you across and beyond a digital transformation or system integration/consolidation/upgrade project, ensuring the data is and remains as it should be – correct, up to date, high quality, and trustworthy.

Your partner for digital transformation

Our goal for each of clients is to provide the most effective services and support required to support their strategic and technical business goals. We are your partner in waiting for any aspect of:

  • Business consulting
  • Technology services
  • Migration services
  • Managed services

Wherever your needs fall across this spectrum, we’d love to discuss how we can help.

For more information, please complete this contact form 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.

Critical dates for OpenText Documentum solutions entering maintenance mode

Critical dates for OpenText Documentum solutions entering maintenance mode

OpenText has announced critical dates for OpenText Documentum solutions for 2023, but instead of a problem you should consider this as an opportunity. Now could be a great time to make a more strategic move to a more intuitive user interface, to a cloud-based platform, or to wider system consolidation involving archiving of inactive content. A timely review will reveal your best options and roadmap. 

Solutions entering maintenance mode 

There’s nothing like a new year to usher in change. For IT teams and business tech decision-makers, January 2023 signals a countdown to a whole raft of OpenText™ Documentum™ products entering maintenance mode, halting functionality updates to make way for new and updated product versions.  

This April will mark the lifecycle end for several products in the Documentum stack including: 

  • OpenText Documentum Archive Services for SAP® Solutions 16.4 
  • OpenText Documentum  Content Services for SAP Solutions 16.4 – upgrade to 22.2 
  • OpenText Documentum D2 16.4 – upgrade to 22.2 
  • OpenText Documentum D2 +Pack 16.4 – upgrade to 22.2 
  • OpenText Documentum D2 Advanced Publishing Services 16.4 – upgrade to 22.2 
  • OpenText InfoArchive 16.4 – upgrade to 22.4 

With more to follow by December 2023: 

  • OpenText Documentum D2 16.5 – upgrade to CE 22.4 
  • OpenText Documentum D2 Advanced Publishing Services 16.5 – upgrade to CE 22.4 
  • OpenText Documentum for Capital Projects 16.4 – upgrade to CE 22.4 
  • OpenText Documentum D2 +Pack 16.5 – upgrade to CE 22.4 

This phasing out of current versions of critical content management applications (a full list can be found here, or contact us to get full details) means that performance and features will no longer be enhanced or improved. From the beginning of December 2023, there will be no more hot fixes, new releases, Java versions, or browser updates without significant extra fees. 

Opportunity for improvement 

While possibly frustrating, reaching a crossroads like this can be quite useful, encouraging new decisions and actions to improve, augment, or upgrade existing solutions.  

Most companies don’t gain value in absorbing extended support arrangement fees, continuing costs of maintaining aging on-premise environments, or additional costs for performance that steadily deteriorates. Nor do they benefit from legacy applications that tie users to old databases and inefficient versions of operating systems. 

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. 

Rather than persist in a state of inertia, 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. 

There are also many opportunities to improve user acceptance, motivation, and system adoption by implementing a modern, efficient interface.  

Here’s a practical plan

First step: Understand what you have 

It’s vital to first understand where your current systems are, which solutions will be impacted by the changes, how they are interconnected, and how important each of those solutions are to your business processes and workflows. We recommend conducting a comprehensive review and analysis of your current technology estate to define and prioritize your environment, risks, and solution options. As an OpenText and Documentum implementation partner, fme has developed and refined a series of specific workshops that can walk you through this process and provide a list of options on how to proceed. 

With a clear understanding of your current state, you will be able to consider current and emerging opportunities, as well as requirements on the technology or business side that are currently unfulfilled. Emerging opportunities might include a previously talked-about move away from local systems and inhouse application management to a cloud-first set-up as part of an IT modernization or digital transformation initiative. Or maybe just a version upgrade is all that is needed to be future-proof.  

Next: Look to the future 

An in-depth analysis process is an excellent way to have a comprehensive IT health-check before committing substantial resources, and will allow you to create an informed cost-benefit analysis.  

Some companies delay IT investment for as long as possible, even if limping by with a patched system could cost more in the long run, increase the potential of risk, and absorb more internal resources in ongoing maintenance. For many, a smaller, strategic investment now can minimize or even eliminate future issues, and ensure systems will meet their requirements for the coming years. Others choose to start a large initiative now and realize the benefits of new solutions before their competition.  

Regardless of the chosen scenario, implementing the new set-up and migrating the designated content could take several months, so the sooner teams are aware of their current state and can make an informed decision, the better the chances of a smooth transition. 

Now: Engage the experts 

fme is perfectly positioned to help companies evaluate and navigate the forthcoming OpenText Documentum upgrades, thanks to the long-standing partnership between our companies and our expertise across all of the linked platforms. Our pedigree includes:  

  • 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. 

Additionally, fme has led the industry by developing our proprietary platform solution migration-center, specifically designed to provide highly automated, large-volume migrations without system downtime for complex migration scenarios. This allows our customers to reduce costs, manage risks, increase productivity, and speed up the go-live of enterprise content management (ECM) applications. 

End-to-end 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 disparate data silos across systems 
  • Migrate complex data and content
  • Run, maintain, and support the applications on-prem or in the cloud  

    Please find more details about our approach for your success here: 

    Whatever the scope of your OpenText Documentum-related projects in 2023, why not let us help lighten the load? 

    Contact us today 

    For more information, please complete this contact form 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.