fme compliance center: Validation at the speed of business

fme compliance center: Validation at the speed of business

The rigidly comprehensive CSV (Computer Software Validation) model and its tedious testing and documentation have finally given way to a risk-based CSA (Computer Software Assurance) approach. It’s an improvement, but this doesn’t mean validation is easy to execute or document.  

fme compliance-center is here to solve that challenge. 

Remove validation-related barriers

The validation costs required when upgrading systems in a Life Sciences firm have put digital transformation initiatives out of reach for many. While CSA is intended to minimize this barrier, leveraging a CSA-based approach requires businesses to assess risks and apply appropriate testing steps when performing validation of systems. fme compliance-center delivers a complete end-to-end solution to address these needs.

fme compliance-center streamlines validation

Based on the CSA guidelines and our 25 years of working with global pharmaceutical and medical firms, fme compliance-center is specifically built to streamline validation workflows. With an intuitive interface and clear instructions, the solution walks you through each validation process step, providing detailed guidance on when you can take advantage of CSA, when traditional CSV is required, and when a hybrid approach is possible.   

 In the end, fme compliance-center saves users time and money, and implements solutions quicker while delivering a higher quality product.  

Learn more about fme compliance-center

Join fme’s validation experts for an in-depth introduction to our newest solution that delivers fit-for-purpose QMS capability for companies in a paperless cloud platform. We’ll demonstrate how fme compliance-center:

  • Drives the risk assessment process to determine the appropriate testing levels

  • Provides the tools and templates to conduct the testing

  • Automates the document management and reporting activities

We’ll also show how our CSA-based guidelines help you organize, execute, and document your critical validation tasks in an easy to understand dashboard that connects your people, processes, and content across your business.

Reserve your spot today to ensure you receive the full recording to share with your team!

Webinar Details

fme compliance-center: Validation at the speed of business

Date: Wednesday, May 31, 2023
Time: 10am EDT

Challenges of managing and maintaining on-premise and cloud business applications

Challenges of managing and maintaining on-premise and cloud business applications

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.

Preparing for Migration: Critical steps to know

Preparing for Migration: Critical steps to know

In a previous article “Migration strategy and the path to operational resilience”, we examined the relationship between data migration and regulatory compliance, and the importance for enterprises to create a clear plan for initiating a data migration. Today, we will look at how migration is never one size fits all, and how each company’s migration journey will be different, requiring strategic approaches linked to the complexity of the unique data. There are several key steps to ensure migration initiatives are as streamlined as possible.

  • Understand the project scope: Assessing the quality of data, requirements, and complexity of data will help you set the right migration strategy.
  • Set realistic timelines: The assessment phase will help create an achievable migration plan that includes an ability to clearly measure progress.
  • Define the migration rules with the experts: Allow the migration expert to come out with the migration order and the rules for you to confirm.
  • Validate the migration: Set the testing strategy during the assessment phase. Conduct preliminary testing during the building phase and confirm with the business that all use cases were considered when preparing the test scripts.
  • The final migration strategy: The migration strategy dictates how the migration will be performed, on a one time basis or incrementally, and how to shut down and dispose of old legacy systems.
  • Sanity checks in production: Once the migration is complete, a sanity check on the agreeable amount of migration data should be initiated to prove that the migration is performed in accordance with the validation phase.

Define the scope of the project

Scoping a migration project involves defining the parameters, requirements, and goals of the project, and developing a clear plan and timeline for the migration. It’s also important to define the limits of the project and identify what won’t be included in the current phase.

For example, in the pharma industry, the implementation of the IDMP (Identification of Medicinal Products) standards requires updates, changes, and possibly even the roll-out of a new information system, but this type of agile modus operandi doesn’t always align with the pharma industry’s historically siloed way of working. Nearly every team in the drug development lifecycle – safety, clinical, regulatory, and research and development – can use different, disconnected systems that might not even integrate (e.g. Submission management, RIM, Master data management, Pharmacovigilance, Document management system etc.). Additionally, they are encouraged by the IDMP implementation to apply a single unified, holistic platform that removes silos connecting data and people.

When a decision on the implementation of a new solution and migration is made, it is important to set a clear scope and goal for the whole project. In the context of the implementation of regulatory solutions in the pharma industry, this can be a big deal for the company and the comprehensive assessment of the project is of paramount importance.

Getting started: Plan a data assessment

Before commencing, it is critical to have a clear overview of the project scope, data, and information to ensure efficient planning and execution. Data migration projects in the life science space are often complex, time-consuming and in most cases involve multiple systems and different technology. A clear and comprehensive assessment phase is key to avoiding exceeding predetermined budgets, implementation delays or undercutting business processes. The assessment phase is primarily used to review and assess the data in the existing systems and identify any potential issues and risks that might occur during the project. The purpose of this phase is not to carry out any migration activities, but to benchmark the scope, set recommendations, strategy and ensure visibility for the client. At this juncture, the client should have already known the migration requirements and the expectations for the migration. As a result of the assessment, a decision can be made to go further with the major project after the plan is clear or whether a POC (Proof of Concept) should be performed to assess some more complex data of the migration (e.g. Migration of the drug registration history).

Choosing the right migration approach

Once a thorough data assessment has been carried out, the next step is to decide on the right migration approach. Every company’s data is unique, and the appropriate migration strategy will depend entirely on the quality, value, and complexity of the data. For example, sensitive regulatory data should be handled with particular care. Moving ahead without proper planning will ultimately cause more work in a later phase, and possibly undermine a project’s success. We often recommend businesses to migrate registrations of important products separately and the rest after the go-live, using the same migration rules. This decision can be made if a high volume of data should be enriched, and the business cannot provide them on time. Another important consideration is whether to migrate everything at once – a Big Bang migration – which requires considerable time and resources to complete. Alternatively, businesses can carry out the migration incrementally and transfer data in phases – this is a rolling migration. A big bang can be more straightforward, but a problem with this approach is that no additions or changes can happen during this time, as all data processes are paused during the migration process. An incremental approach doesn’t require as much downtime but can bring more complexity as the source and the target system are run in parallel, eliminating downtime.

 Aligning project & migration timelines

Knowing when to initiate the migration is pivotal. Ideally, the migration should take place in parallel with the solution implementation process, and the development of the migration rules should follow the implementation cycles. For example, when the solution implementation of master data is locked, the definition and development of the migration master data can start and eventually be migrated. After each cycle, the business should confirm the migrated data in the target system and if all the requirements were fulfilled. This approach tells us that we need to understand the whole concept of the project, including the implementation of the solution when building the plan. Otherwise, it is impossible to set all cycles in a logical order and set the right priorities. It is essential that the data migration is carried out in tandem with domain experts that have the technological know-how and strategic acumen to deliver.

Consider a Proof of Concept data migration

Rigorous planning and assessment are critical to the success of any data migration project, and in some instances, a proof of concept (POC) is highly advisable. A POC data migration is essentially a trial run of a larger data migration project, geared towards testing the feasibility of migrating data from one system to another. The purpose of the POC is to demonstrate the viability of the data migration project and to identify any potential issues or challenges that may arise during the actual migration process. When a company is approaching a large-scale data migration, or a high-risk migration involving sensitive or mission-critical business data, a POC can provide significant value.

For a successful POC, it is important that the business provides rich sample data so that the migration team can test and verify the exact processes that will be used in the full migration.  Before running the POC, businesses should:

  • Review sample data sets and consider all use cases
  • Confirm the result of the migration fulfills the requirements
  • Examine and define any gaps and how to fill them
  • Define what work is required if they need to enrich their data

By its very nature, migrating data can be a complex and protracted process, and if not thought out fully in advance, can lead to significant data loss and system downtime. In our next blog, we will highlight the key success factors and best practices for optimized migration.

Contact us to start your migration right

Whatever the reason for the data migration, the goal of all stakeholders is to provide a solution to the business in order to improve business performance and ensure competitive advantage. To achieve this, they should give more attention to data migration and be smarter in the assessment, planning, and migrating data with experts that have experience and knows the business in the life science industry.

fme has been guiding global pharmaceutical and manufacturing firms through their complex migration journeys for over 20 years. We’ve even developed our own proprietary tool migration-center to enable seamless migrations with minimal downtime. Contact us to discuss your challenges and start your journey on the right path.


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

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

Veeva Technology Certified Silver Partner
Veeva Services Alliance Partner Certification Badges with Year 2023_Services
Veeva Services Partner Migration-Certified

The 2023 Veeva Summit: R&D and Quality for clients and partners is fast approaching, and fme has been selected to share our experience and strategies as a Gold sponsor. Only a select group of certified partners are invited to participate, and fme is honored to be recognized as part of this elite group. We cordially invite you to join us to explore how we can work together to leverage the power of the Veeva platform to achieve your business goals.

Proven Success Strategies

The Veeva Conference is a fantastic opportunity to learn about the most effective trends and best practices for content management, network with industry professionals, and engage in insightful discussions. Since fme specializes in the implementation, integration, and support of Veeva content management solutions, we’ll be sharing our experience on how to best configure, utilize, and support Veeva for the unique challenges of your organization.

The Veeva Summit provides unique value to attendees:

  • Gain insights into the latest features and enhancements of Veeva’s content management solutions, how they can help you achieve your IT and business goals.
  • Understand how fme provides tailored IT consulting services to optimize your Veeva solutions, ensuring seamless operation and maximum ROI.
  • Network with other professionals to exchange ideas and learn from their experiences, helping you stay ahead of industry trends and competition.

Join fme at the Veeva Summit or Contact Us Today!

If you attend or not, take full advantage of the Veeva Conference for valuable learning opportunity it provides. Our team of experts will be answering questions, demonstrating our capabilities, and proving how our partnership can bring your organization to new heights. We will also be introducing new offerings that will bring 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 – Modeled after our popular dqMan for Documentum, our newest version is focused on the specific requirements of Veeva clients, eliminating time-consuming and repetitive tasks and making admin and data management easy.
  • fme MetatdataAssist™ – Reconnect lost documents without the frustration, time, or costs to your key business resources. Let fme’s life science experts quickly and efficiently update your legacy document’s metadata to ensure they are properly classified and discoverable in your Veeva system.

If you aren’t attending, contact us to schedule a personalized presentation on how fme can provide the end-to-end knowledge and support you need to maximize the value of your information with the Veeva platform.

To learn what fme can do as your end-to-end Veeva partner and to get more details on the conference, view our Veeva Summit summary here. To schedule a discovery meeting with fme’s Veeva experts, use the form on the page above, or reach out to me or our Global Sales Director René Rosenberg at

fme compliance-center solves validation challenges

fme compliance-center solves validation challenges

At last! An end to many of the onerous software validation activities will boost innovation in Life Sciences.

It’s been a long time coming, but a new risk-based approach to computer software assurance looks set to spur new digital advancement in Life Sciences. After a quarter of a century of the rigidly comprehensive Computer Software Validation (CSV) model, in which each and every tweak to an IT system led to a whole raft of testing and documentation, the FDA has published new draft guidance with an emphasis which is more fit for purpose.

Rather than enforce a checklist of no-exceptions tests, the new Computer Software Assurance (CSA) model will be geared to the impact of any changes to a system. It will require new testing and associated documentation only if there is likely to be a direct effect on the product or on patient safety. Indiscriminate testing of logins and similar low-risk processes will no longer be required – or incur the risk of a failed inspection if not completed.

Removing the validation-related barriers to digital transformation

The update to the FDA requirements comes just in time. Over-zealous requirements have caused a reticence to upgrade systems in a Life Sciences Regulatory context because the cost of validation is often two to three times the original cost of the software. While a large company with a sizeable budget and ample internal resources might be able to weather this comfortably, the same hasn’t always been true and cannot always be said for small businesses along the supply chain. Neither size company wants this added cost.

This is one of the reasons Life Sciences has lagged behind other industries in digital innovation. Years ago, analyst firms put the sector at 17th for innovation, a barely altered ranking. If a mundane transactional system had to be put through its paces each time an adjustment was made, consider how much more of a barrier introducing an AI-based capability would have been under the outgoing regime would be.

Although the new approach is still only at a draft guidance stage, the excitement around the change is palpable. Suddenly, even the regulators are pushing for digital innovation in how Life Sciences companies manage their processes, and this impetus for change is now driving the FDA’s new approach to software assurance.

Reducing complexity & cost of validation

The new emphasis on risk-based and ad-hoc software assurance checks and documentation could reduce the time and cost burden by as much as 80%. Instead of resigning themselves to weeks of writing scripts and capturing screens, IT teams will be able to explore the potential for concepts like:

  • AI-based safety signal detection;
  • advanced use of Regulatory intelligence to drive pipeline development and submission strategies;
  • and adopting more innovative interfaces (e.g., voice assistants) to drive complex RIM queries.

At last, companies will be able to reduce their reliance on Excel spreadsheets without worrying about adding to an already overwhelming validation worklist.

Cultivating greater cloud use

Next-level cloud adoption is likely to increase because there won’t be the same requirement to track down and physically visit hosting data centers to check on fire alarms and the like. Instead, third-party assessments will usually be acceptable, opening new opportunities to embrace the latest remote capabilities.

It might be the best part of another year before the new provisions apply, but knowing that the FDA is altering its approach to software assurance paves the way for bolder tech-based ambitions today – whether that’s around AI capabilities or enhanced inter-system data integration.

And fortunately, we’re fme poised to help companies chart and respond to these opportunities. Our new compliance-center solution encapsulates the FSA’s new CSA approach in a digital platform, delivering a fit-for-purpose QMS capability for companies in a paperless cloud platform.

Read more about the advantages of CSA over traditional CSV here and keep an eye out for the compliance-center webinar in May. We’d be delighted to share more about it – so why not get in touch?

Read more and watch the fme compliance-center™ webinar here

About the author

David Gwyn is a strategic, creative, and data-driven Business Development and Technology Specialist with extensive expertise in building key partnerships, implementing business strategies, and deploying solutions across the life science and emerging technology industries. In October 2021 he joined fme US as the Business Unit Director for Business Consulting. For the past 30 years, he has led teams in the delivery of content management, clinical, and quality solutions with a recent focus on end-to-end Regulatory Information Management (RIM). His practice has evolved in parallel to the Life Sciences industry, moving from custom-developed software solutions to packaged-based implementations, and the development of methodologies and best practices to guide practitioners in realizing the greatest return on investment. Mr. Gwyn is passionate about helping organizations evolve from traditional to digital businesses and increase their ability to act with speed and agility.

Smoothing the road to RIM transformation with Veeva

Smoothing the road to RIM transformation with Veeva

Putting data integrity first in digital transformation

So much of the value of pharma R&D companies is in the data they produce and own. Yet when embarking on digital transformation programs – such as regulatory information management (RIM) migrations using a modern platform such as Veeva – many organizations overlook the work that will be involved in preparing legacy data so that it can be used optimally and confidently in the new system.

As many terabytes of information are moved across to the new platform, very real challenges around that data’s quality, integrity, completeness, and fitness for future purpose can arise. And unless these issues are addressed ahead of or as part of the migration, the new platform will never be able to deliver to its full potential.

Making smooth work of data migration for a mid-sized global pharma R&D company

In a recent client project that I worked on with Veeva and data migration specialists fme, the need for foundational data work was recognized and provided for up front. This had a direct bearing on the successful implementation and outcomes of the new Veeva RIM system.

The company, a global, mid-sized pharma organization, was embarking on a major international program to modernize its Regulatory documentation and submission management capability, which would require extensive content mapping and data enrichment.

fme brought immediate value here, able to fill gaps in the client’s internal knowledge. For instance, fme had expert knowledge of the target Veeva system, being a certified Veeva partner, and of the scope of the data clean-up, preparation, augmentation/enrichment, and validation that would be required.

Containing any risk with the fme migration-center

Crucially, fme was able to call into play its migration-center. This is its own proprietary platform for high-volume and complex content migration. The fme migration-center allows all the data verification and preparation work to happen in a ‘safe’, validated environment without disrupting the primary, live Regulatory Affairs system. The dedicated toolkit takes care of all the translation work by working on a series of ‘deltas’ – for example, starting with historical and fairly static records, then progressing to data that is still changing. This carefully honed process for data extraction plays an important role the minimizing risk of large-scale data migration work.

fme’s tools and experience reduced migration time by a third

The result of all this meticulous work, the vast majority of which was able to happen safely offline, was that the total migration took just 12 months – a whole six months faster than anything I have experienced previously in my two decades of large system implementations. Certainly nothing so comprehensive, involving such vast volumes of data and such extensive data translation and augmentation. The speed was quite phenomenal.

Importantly, it isn’t just the level of technical expertise that fme brings to such projects that sets the company apart. It’s also the consultants’ knowledge of Regulatory processes and data in Life Sciences, and their ability to bridge technical and business teams in getting across what needs to be done.

A certified partnership

As I said at the outset, data is probably THE most valuable asset a pharma R&D company possesses, so upholding its integrity and securing its long-term potential is absolutely critical.

For the global client, the new global Veeva system went live as planned and was hugely successful. It is one of many data migration projects fme has worked on with Veeva, whose platform today is the industry standard in Life Sciences for RIM modernization.

One of the hallmarks of fme’s work is the close relationship its consultants form – with Veeva, with the client, and with any other consultants who may be involved (in this case, me). Nothing is ever ‘thrown over the fence’; ownership of the project success is very much shared and respected.

I now work regularly with the specialist team at fme and, thanks to the meticulous planning and attention to detail which comes from such deep experience and subject matter expertise, our projects are among the smoothest I have ever witnessed.

Get started, risk free

Don’t let your migration start off down the wrong path. Set the right direction by taking advantage of a free 30-minute analysis with our Life Sciences expert and Business Unit Director, Ian Crone. His unique combination of sector understanding and technological knowledge give him an unparalleled perspective on the possibilities and pitfalls inherent in complex transformation initiatives in this complex and highly regulated industry.

About the author

Guest author Jon Sanford is an independent regulatory/RIM expert at Rubus Ilex. He has worked in the field of Regulatory Operations for two decades and has over 30 years’ pharmaceutical experience, which has included managing a team of Regulatory Operation professionals responsible for publishing regulatory dossiers across Europe and Asia and Latin America. He has also been the business lead on a number of Global Document Management Systems, Regulatory Publishing Systems and RIM implementations.