Is Your Veeva RIM System Falling Behind?

Is Your Veeva RIM System Falling Behind?

You invested in Veeva RIM to stay ahead—so why does it feel like you’re always catching up?

With three major product releases each year, Veeva RIM evolves constantly. While this pace of innovation is exciting, it also places a heavy burden on your internal teams to keep up. New configurable features are introduced regularly—some automatically turned on—and organizations often fall behind in implementing them. This not only limits your system’s value but introduces risk, inefficiency, and frustration across your regulatory operations.

fme’s HealthCheckAssist℠ is designed to help you take back control. Our service identifies exactly where your configuration, data, documents, and security model are falling behind—and gives you a roadmap to catch up fast.

Are You Seeing These Warning Signs?

Many teams using Veeva RIM experience one or more of these problems:

  • You aren’t sure which features are active—or if they’re being used
  • Your metadata is inconsistent and hard to report on
  • Your security model is slowing down access or creating user friction
  • You’re relying too heavily on workarounds
  • You’re preparing for a regulatory inspection and unsure if your system is truly compliant
  • Your team complains that “Vault doesn’t work” when the issue is configuration, not capability
  • Modern Platforms Evolve—Has Your Configuration Kept Up?

Veeva’s model of three releases a year is a leap forward compared to static, on-prem systems. But it comes with a new kind of pressure. Features are released with little warning, configurable settings change, and legacy configurations may block you from taking advantage of what’s new. Worse, these changes may seem small—but they can add up to missed functionality and diminished ROI.

Veeva RIM has the power to drive incredible efficiency—but only if it’s aligned with your business process and organizational maturity. HealthCheckAssist ensures you’re not missing out on what you’ve already paid for.

Is Your Security Model Getting in the Way?

One of the most common signs that your system is falling behind is when security becomes more of a roadblock than a safeguard. We often find clients with hyper-granular access models, overly complex user roles, or workflows that frustrate rather than empower.

This complexity leads to increased admin time, slow issue resolution, and poor user adoption. HealthCheckAssist helps you identify where to redesign your security to strike the right balance: protecting your data while enabling your teams to work.

What HealthCheckAssist Delivers

HealthCheckAssist is a structured, low-burden assessment that gives you clear, actionable insights into how your Veeva RIM environment is being used and how to fix what’s broken or outdated. We don’t just point out what’s wrong. We give you a strategic plan that outlines exactly how to get your system back in shape.

Our assessment includes:

  • Stakeholder and user interviews to capture frustrations and goals
  • Review of feature usage (or under-usage) across key objects like Events, Objectives, HA interactions, and more
  • Data and document quality evaluation, including naming consistency and metadata completeness
  • Security model analysis, including role design and permission complexity
  • Training and documentation assessment to identify gaps in user enablement
  • Turn Regulatory Change Into Strategic Advantage

One of the most overlooked challenges in Veeva is staying release-ready. With HealthCheckAssist, we help you anticipate upcoming platform changes, leverage features that enhance productivity, and avoid the trap of always being in ‘reactive mode.’ You’ll no longer be left wondering, “What did we miss in the last release?” Instead, you’ll be confident that your system is future-proof.

Bonus: Supercharge Your Admins with dqMan

As part of every HealthCheckAssist engagement, we include a 1-year license of dqMan—our advanced Veeva query and metadata tool. dqMan empowers your admins to run fast, deep queries across Veeva Vaults, edit metadata in bulk, and troubleshoot with precision. It’s an ideal complement to your internal support model and a powerful tool to accelerate cleanup and optimization. 

fme developed dqMan to provide a professional administration tool designed to boost productivity and maximize your efficiency as a Veeva Vault expert. Carefully crafted on the robust dqMan platform, this tool reveals the true power of the VQL (Vault Query Language) and MDL (Metadata Definition Language). It provides users with exclusive capabilities and a broad feature set while enhancing user accessibility and streamlining operations alongside the comprehensive functionalities offered by Veeva Vault Admin. Seamlessly installable on any Windows machine, our enterprise-grade software solution boasts an intuitive user interface, delivering a great user experience.

Say goodbye to manual, time-consuming tasks and focus on what truly matters—efficiently managing your Veeva Vault applications.

HealthCheckAssist Delivers Results

  • Faster access to information and higher user satisfaction
  • Streamlined, compliant security model that scales
  • Increased feature adoption and configuration alignment
  • Strategic roadmap to unlock platform value
  • Enhanced document and metadata quality
  • Improved readiness for inspection or global rollout

Let’s Catch You Up—And Keep You Ahead

Don’t let your Veeva RIM system fall behind just when you need it most. fme’s HealthCheckAssist gives you a clear, fast, and effective way to assess, align, and accelerate your Veeva RIM configuration.

Download the HealthCheckAssist datasheet below and contact us today to get started—and start using everything your system has to offer.

The Inspection’s Over, but the Damage Is Done: Why Your QMS Might Be Failing You

The Inspection’s Over, but the Damage Is Done: Why Your QMS Might Be Failing You

Introduction: The Illusion of Compliance

Many organizations assume their quality management processes are under control. They pass audits, maintain their documentation, and follow established workflows. Then, an unexpected inspection or internal review uncovers a major issue. A closed deviation has no connected Investigation or CAPA, let alone an effectiveness check, associated with it. A missing training record delays a product release. An audit report takes weeks to assemble because critical data is scattered across multiple systems.

These problems do not result from a lack of effort. They stem from outdated or disconnected systems and processes that make compliance more complicated than it needs to be. Companies do not realize how much time and effort they spend managing inefficiencies instead of improving quality. The result is frustration, wasted resources, and increased regulatory risk.

The Hidden Weaknesses in Quality and Compliance Systems

Regulated companies spend millions on compliance, but even well-funded quality programs struggle with everyday problems. These challenges develop over time and often go unnoticed until they cause actual harm.

Disconnected Systems and Siloed Data

Most companies use separate tools for document control, CAPA management, training records, audits, and inspections. When these systems do not integrate, teams must manually transfer information. Data discrepancies become common, and people waste time searching for records. Inconsistencies across systems lead to confusion and gaps in compliance.

Inconsistent or Outdated Controlled Documents

Many organizations maintain many SOPs, work instructions, and policies. Without a strong document management system, outdated versions may circulate, leading to noncompliance. Employees may not know which procedures to follow, and regulators may question whether training and document updates are correctly linked.

CAPA and Deviation Management Failures

Corrective and preventive actions should eliminate recurring quality issues, but they often fall short. CAPAs may be opened without clear owners or timelines. Deviations may not be thoroughly investigated, leading to repeated problems. When audits reveal recurring issues, companies realize too late that their CAPA process has not been effective.

Audit and Inspection Readiness Gaps

Companies often scramble to prepare for audits because records are scattered across different systems. If a regulatory inspector asks for proof of compliance, assembling the correct data takes too long. When quality teams must manually piece together records, they risk missing important details.

Poor Data Quality and Visibility

Quality systems depend on accurate data, but many organizations struggle with outdated, duplicate, or incomplete records. Searching for critical information becomes difficult if documents lack proper metadata or are stored in inconsistent formats. Poor data integrity makes tracking trends, identifying risks, and demonstrating compliance harder.

When to Consider a New Quality Management System

If these challenges sound familiar, your organization may rely on systems that no longer meet its needs. Many companies put off replacing their QMS because change is difficult. However, holding on to an outdated system carries its own risks.

A modern QMS does more than store records. It helps teams manage processes efficiently, ensures compliance, and provides better oversight of quality operations. Companies that upgrade their quality systems benefit from:

  • Data enrichment and remediation during migration ensure documents are correctly classified and easily retrieved.
  • Process standardization, improving efficiency, and reducing compliance risk.
  • Enhanced visibility, allowing quality teams to track issues more effectively.
  • Scalability, ensuring the system can handle new regulatory requirements and future growth.

Selecting the Right System Requires More Than a Simple Technology Upgrade

Choosing a new QMS or QDMS is a strategic decision. The wrong choice can lead to frustration, poor adoption, and wasted resources. The selection process should involve key stakeholders, define business requirements, and consider integration with existing systems. A structured selection approach helps organizations avoid costly mistakes.

fme has helped life sciences companies select and implement quality systems that align with their business needs. Our SelectAssist for Quality service guides organizations through the selection process, ensuring they choose the right platform and optimize their transition.

Upgrading a quality system is an opportunity to strengthen compliance, eliminate inefficiencies, and future-proof operations. If your current system makes compliance harder than it should be, it may be time for a change.

Selecting the Right RIM & Publishing Solution: How fme’s SelectAssist Guided a Leading Pharma Company to a Confident Decision

Selecting the Right RIM & Publishing Solution: How fme’s SelectAssist Guided a Leading Pharma Company to a Confident Decision

The Challenge: Navigating a Complex Selection Process

For a leading global pharmaceutical company, selecting the right platform for managing regulatory registrations and publishing was critical. With their existing submission document management and submission archiving systems remaining in place, the organization needed to identify the best solution to complement these systems while enhancing their overall regulatory operations.

The challenge wasn’t just finding a platform with the right capabilities; it was about ensuring a methodical, data-driven selection process that accounted for technical requirements and user experience. The company required a structured approach to define and evaluate requirements, manage vendor demonstrations, and present a well-supported recommendation to senior leadership.

The SelectAssist Approach: A Structured and Data-Driven Process

Enter fme’s SelectAssist, a proven methodology designed to help life sciences organizations navigate the complexities of software selection. Our approach ensured the client’s selection process was systematic, comprehensive, and aligned with their business objectives.

1. Requirements Definition & Prioritization

Working closely with stakeholders, fme facilitated the creation of a detailed set of functional, technical, and business requirements. Using qualitative and quantitative measures, we ensured that every need was captured, prioritized, and weighted based on importance. The process included:

  • Gathering input from business, IT, and regulatory stakeholders
  • Structuring requirements into a detailed matrix with over 2,500 unique requirements
  • Establishing scoring criteria for vendor evaluation

2. Vendor Evaluation & Demonstration Management

With a strong foundation of requirements, we supported the client’s procurement team as they engaged vendors and managed the selection process. Our role included:

  • Assisting in defining the Request for Information (RFI) process and ensuring alignment with business needs
  • Providing guidance on vendor selection criteria and helping the client narrow down the initial list of six vendors
  • Designing scripted demo sessions that required vendors to showcase real-world use cases rather than generic presentations

Using scripted demos, we ensured that vendors demonstrated how their platforms would handle specific regulatory workflows, giving stakeholders a true sense of usability and fit.

3. Conference Room Pilot & User Feedback Analysis

To further validate vendor capabilities, fme facilitated Conference Room Pilot (CRP) sessions, allowing key users to test the solutions in real-world scenarios. During this phase, we:

  • Designed hands-on evaluation scenarios aligned with actual regulatory workflows
  • Collected user feedback through structured surveys, gathering over 50 individual evaluations from key stakeholders
  • Combined user sentiment with objective performance data to create a well-rounded assessment

By structuring feedback collection, we quantified user impressions and balanced them with objective performance metrics, ensuring that the selection was based on a blend of user experience and functional fit.

4. Final Selection & Executive Presentation

With all data collected, our team compiled the findings into a comprehensive evaluation report. This included:

  • A side-by-side vendor comparison based on weighted criteria
  • A risk assessment for each potential solution
  • A recommendation backed by both quantitative data (scoring, performance metrics) and qualitative insights (user sentiment, stakeholder interviews)

The final step was delivering an executive presentation that distilled complex selection criteria into a clear and compelling case for senior leadership. Our structured reporting helped secure executive buy-in, ensuring a confident and well-supported decision.

The Results: Confidence in the Right Choice

Through SelectAssist, this leading global pharmaceutical company was able to move forward with confidence, knowing that the selected platform was technically sound, user-validated, and strategically aligned with their long-term regulatory goals.

By leveraging a combination of quantitative scoring, structured vendor demos, and user-driven evaluations, the company not only minimized the risk of selecting the wrong solution but also maximized the chances of successful implementation and adoption.

Why SelectAssist?

fme’s SelectAssist methodology offers life sciences companies a structured, transparent, and data-backed approach to software selection. Whether evaluating Regulatory Information Management (RIM), Publishing, Quality, or Clinical systems, our approach ensures:

  • Comprehensive requirements definition – Aligning software selection with strategic business needs
  • Seamless integration consideration – Ensuring the new platform fits within existing infrastructure
  • Stakeholder engagement & adoption – Prioritizing end-user needs for long-term success
  • Balanced decision support – Combining technical, financial, and usability assessments
  • Future-proof solutions – Selecting platforms that can adapt to regulatory changes and business growth

Are you facing a similar challenge in selecting the right software for your regulatory or quality operations? Download our SelectAssist datasheet below and contact fme today to learn how SelectAssist can provide the clarity and confidence you need to make the right choice.

Deep Dive into Regulatory Solutions at DIA RSIDM 2025

Deep Dive into Regulatory Solutions at DIA RSIDM 2025

This February, DIA RSIDM 2025 returns to Bethesda, MD, reaffirming its reputation as the premier event for regulatory professionals to exchange the best solutions for managing complex regulatory submissions. At fme, we specialize in helping pharmaceutical and biotechnology companies navigate regulatory challenges with expertise in selecting, planning, and migrating to RIM solutions tailored to their unique data, documents, and workflows. Visit us at Booth #315 during the RSIDM forum—we’d love to discuss your challenges and plans for 2025!

Operational Efficiency is Critical

Every day, pharmaceutical companies strive to demonstrate the efficacy of new discoveries and deliver life-changing medications to patients in need. To accelerate time-to-market and ensure safety, timely and high-quality regulatory submissions to health authorities are critical for review and approval.

However, the process is fraught with challenges. The sheer volume and complexity of data, documents, and information exchanged among multiple stakeholders and systems create significant hurdles in maintaining accurate, up-to-date documentation. Errors, omissions, or inconsistencies can lead to costly delays and disrupt expected release timelines.

Seasoned regulatory professionals recognize the importance of operational efficiency in managing regulatory information effectively throughout the development cycle, ensuring smooth and successful submissions.

Keys to RSIDM Efficiency and Success

Efficiency and success in regulatory operations depend on seamlessly aligning people, processes, and technology throughout a medication’s journey—from conception to patient use. With years of experience and a proven track record, fme has gained deep insights into the complexities of every phase of this journey. This expertise has enabled us to develop and refine methodologies that:

  • Analyze existing systems and workflows
  • Align requirements with tailored technology solutions
  • Ensure data and documents are accurately classified for discovery and use

fme’s experts combine a deep understanding of the product development lifecycle with extensive experience in regulatory projects. Staying ahead of evolving data standards, requirements, and technology trends, we guide clients toward the best solutions for today while future-proofing their decisions to deliver long-term ROI.

Download this overview to see how fme can help you achieve regulatory excellence and why we are recognized as a leader in content management solutions for regulatory environments.

Connect with fme at DIA RSIDM 2025

Last year, fme’s David Gwyn spoke on “Leveraging Structured Content Authoring in Regulatory Submissions: Real-World Experience, Industry Insights and Tools.” This presentation focused on the latest EDM Structured Reference Model team developments, showcasing how their work influences industry-wide adoption. For more information, view the full details of the session here.

For 2025, David will be joined by RIM experts Jonathan Byars and Frank D’Entrone to provide their expertise on effective strategies to align people, processes, and technology for RIM success. fme’s experience across platforms, industries, and global territories gives us unparalleled insights into the best strategies and solutions and how to ensure a successful journey to regulatory excellence.

What are your challenges for 2025? Use the form below to request a no-cost discovery session and we’ll schedule a time to discuss your concerns and possible solutions. If you are attending RSIDM 2025, join us at Booth #315 and we can start the conversation in person! If you can’t attend this year, download the overview and let us know if you’d like to talk.

The DIA RSIDM 2025 Educational Tracks

The educational tracks for this year’s conference reflect the continued integrated communication challenges regulatory professionals face within a quickly evolving technology landscape. Download the overview above to learn more about how we can support your team in each.

  • Track 1: Building and Sustaining Successful RSIDM Foundations
    • This track is designed for attendees who are either new to the field or seek a comprehensive review of the evolving dynamics and intricacies that shape their day-to-day work.
  • Track 2: Optimizing Processes and Procedures
    • This track is tailored for intermediate-level professionals and focuses on what is needed to improve processes, procedures, and data to foster a culture of innovative practices and forward-thinking. Learn proven industry best practices and discuss the impact of new global regulations on your organization’s processes and procedures.
  • Track 3: Adopting Innovative Technologies
    • This intermediate to advanced track provides first-hand knowledge from global regulatory health authorities on the implementation of new technologies, policies, and guidelines. It also includes perspectives on how to incorporate technology advancements like artificial intelligence and automation, and how to assess their effectiveness and impact.
  • Track 4: Achieving Regulatory Excellence
    • This advanced track is designed for leadership roles, and includes examples and use cases from organizations that have achieved regulatory excellence. It covers a wide range of practical implementation strategies to support vision, cultural change, and commitment to innovation.

We are excited to participate in these valuable conversations with regulatory thought leaders and re-connect with industry colleagues! Find the full RSIDM 2025 agenda here, and contact us if you have any questions about the specific tracks or sessions offered. We look forward to seeing you there!

Transforming Your Quality Management System Selection with SelectAssist℠

Transforming Your Quality Management System Selection with SelectAssist℠

Navigating the complexities of selecting the right Quality Management System (QMS) and Quality Document Management System (QDMS) can be daunting, especially for Life Sciences companies. These industries are highly regulated and require specialized software solutions to manage intricate processes and extensive documentation. You’re not alone if you’re feeling overwhelmed by the selection process. This is where SelectAssist steps in to simplify the journey and ensure you make a choice that supports your current and future needs.

What is SelectAssist?

SelectAssist is a specialized methodology designed specifically for life sciences companies to streamline the QMS and QDMS solutions selection process. Choosing the right software is more than just ticking boxes; it’s about ensuring the solution integrates seamlessly with your existing systems and meets your business’s critical needs.

At the core of our approach is the belief that stakeholder involvement is paramount. Engaging key stakeholders throughout the decision-making process not only promotes higher adoption rates but also significantly enhances the success of the implementation. By listening to the voices that matter most—your end-users—we tailor the selection process to ensure that your chosen software solution is the best fit for your organization. Download our datasheet for specific details >>

The Challenges You Face

Life Sciences companies face unique challenges when selecting software due to the sector’s highly regulated nature. Compliance with multiple quality standards, the need to manage vast amounts of documentation, and the necessity of integrating new solutions with existing software stacks are just a few of the hurdles that must be overcome.

Moreover, understanding the end-to-end quality management experience is crucial to minimizing manual activities and maximizing efficiency. The selection process can be time-consuming, costly, and risky without a methodology that considers these factors.

How SelectAssist Solves These Challenges

SelectAssist addresses these challenges head-on with a comprehensive, industry-tailored approach. Our methodology prioritizes understanding your quality and document management requirements while ensuring seamless integration with your current systems. We focus on both the technical fit and the critical business needs, providing a balanced view that encompasses technical capabilities, financial stability, and the vendor’s commitment to future development.

Our approach begins with involving critical stakeholders from the outset. By incorporating their insights and needs, we ensure the selected software aligns with user expectations and organizational goals. This inclusive decision-making process fosters ownership and ensures higher adoption rates and successful implementation.

The Integration Advantage

An integrated QMS and QDMS offer significant advantages. When your QMS is tightly coupled with your QDMS, you gain enhanced compliance, improved efficiency, greater visibility, and enhanced collaboration. Documents supporting quality processes are directly tied to the processes themselves, providing a comprehensive solution that streamlines operations and effectively meets regulatory requirements.

Our Comprehensive Offering

The SelectAssistSM process is designed to support every stage of the software selection process. From developing a business case and executing a Request for Information (RFI) process to evaluating proposals through scripted demos and Software Verification Workshops (SVWs), we ensure a thorough and informed decision-making process.

Our methodology also includes a future-state assessment of potential vendors, evaluating their commitment to innovation and customer success. This thorough vetting process ensures that the chosen vendor is technically capable and aligned with your organization’s long-term goals.

Benefits You Can Expect

  • Tailored Fit: Aligns QMS and QDMS solutions with your strategic objectives while accommodating your unique regulatory compliance needs.
  • Seamless Integration: Identifies early integration requirements to ensure a smooth user experience.
  • Engaged Stakeholders: Fosters ownership and acceptance among end-users through inclusive decision-making.
  • Balanced Insights: Combines technical capabilities with broader business impacts for well-rounded decisions.
  • Future-proof Solutions: Ensures the software can adapt to regulatory changes and business growth.

Discover More about SelectAssist

Are you ready to transform your QMS and QDMS selection process? Download the datasheet below and contact us to learn how SelectAssist can provide the clarity and confidence you need to make the right choice for your organization. Don’t leave your software selection to chance—let SelectAssist guide you to the solution that fits your needs today and tomorrow.

Why Choose fme?

Our approach is distinguished by our emphasis on understanding the technological and human factors involved in QMS and QDMS package selection. Successful implementation is not just about the software; it’s about aligning with people’s work, integrating into existing systems, and adapting to future changes. With fme, you’re not just choosing a service provider; you’re choosing a partner committed to ensuring your solution is a resounding success. Contact us today to get started.

Navigating the Maze of Regulatory Information Management (RIM) Package Selection: The fme Approach

Navigating the Maze of Regulatory Information Management (RIM) Package Selection: The fme Approach

Regulatory Information Management (RIM) remains critical in today’s ever-evolving pharmaceutical industry. It involves maintaining licensure across countries and publishing the necessary information for health authority approvals. Selecting the right RIM package isn’t just about integrating technology; it’s about ensuring the solution meets complex business requirements and gains widespread user acceptance. This is where fme steps in, employing a meticulous approach to guide companies through the RIM package selection and evaluation process.

1. Understanding the Complexity of RIM

Regulatory Information Management manages and publishes licensure information across multiple countries. As such, purpose-built solutions tailored to these unique demands are required. fme recognizes this need and offers services that understand the intricacies of RIM and the integration challenges with existing software stacks.

2. fme’s Approach to Software Selection

fme’s approach is characterized by a systematic methodology designed to capture both current and future requirements of RIM and publishing. Here’s how we do it:

  • Define Requirements: Before proceeding with solution selection, we work closely with clients to define their current and future RIM requirements, ensuring that any solution aligns with their business objectives.
  • Identify Candidate Solutions: Leveraging our industry expertise, we identify potential solutions that could integrate well with the client’s existing software stack.
  • Drive Evaluation and Selection: Through a series of evaluations, we ensure that all critical voices from the user community are heard, ensuring that the solution meets technical requirements plus user needs and preferences.
  • Support Decision Making: We assist clients in the final decision-making using quantitative and qualitative measures to compare potential solutions.

3. Engaging Key Client Team Members

A unique aspect of our approach is the emphasis on stakeholder engagement. We understand that for any solution to be successfully adopted, it must receive widespread acceptance from its end-users. Therefore, we:

  • Organize Requirement Gathering Sessions: We facilitate sessions with various stakeholder groups to ensure all needs and concerns are captured.
  • Promote Participation in the Selection Process: From defining requirements to evaluating demos and participating in hands-on pilot tests, we ensure key client team members are actively involved in every step.

4. Ensuring a Tailored Fit

Our methodology doesn’t just stop at selecting a package; it ensures the solution is tailored to the client’s organization. This includes:

  • Building the Business Case: We help clients articulate the strategic objectives and analyze financial implications, ensuring the solution delivers value.
  • Narrowing Down Vendors through RFI/RFP Processes: We ensure that only the most suitable vendors are considered through a structured RFI and RFP process.
  • Testing the Solutions: We ensure the solution meets the listed requirements and works seamlessly in the client’s real-world environment through scripted demos and client-driven pilot tests.

5. Finalizing the Selection

The final stage involves a comprehensive vendor assessment, looking at financial stability, product roadmap, and customer references. This thorough analysis ensures the final decision is well-informed and geared towards long-term success.

Learn More

For more details about fme SelectAssist, and how it can benefit your organization download the SelectAssist for RIM datasheet, and contact us to discuss your current challenges.

Why Choose fme?

Our approach is distinguished by our emphasis on understanding the technological and human factors involved in RIM package selection. Successful implementation is not just about the software; it’s about aligning with people’s work, integrating into existing systems, and adapting to future changes. With fme, you’re not just choosing a service provider; you’re choosing a partner committed to ensuring your RIM package selection is a resounding success. Join us in navigating the complexities of RIM, and let’s ensure your regulatory information management is robust, compliant, and efficient. Contact us today to get started.