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.

Optimize and Improve Your RIM System with HealthCheckAssist℠

Optimize and Improve Your RIM System with HealthCheckAssist℠

Regulatory compliance is more complex and crucial than ever, and organizations are under immense pressure to manage their regulatory information efficiently. In addition, the stakes have increased as health authorities responding to public pressure have become increasingly rigorous in their evaluations, issuing more fines and penalties than ever. The health authorities are also striving to standardize data submissions in ways that organizations may not be ready to meet.

Common Regulatory Challenges

Organizations face numerous immediate challenges in managing regulatory information:

  • High volume of data and documents
  • Data fragmentation over time and platforms
  • Adherence to evolving standards
  • Inefficient processes across teams
  • Compliance risks
  • Legacy systems being consolidated into new platforms
  • Frequent RIM platform updates to stay current with complex and changing regulatory environments from multiple Health Authorities worldwide

As companies grow, merge, and acquire new data, many struggle to maintain operational efficiency and ensure compliance with mission-critical global regulatory requirements.

Modern Platforms: A Double-edged SaaS

There’s no question that today’s cloud-connected SaaS solution platforms are a fantastic leap forward in technology. Unfortunately, their undeniable benefits also come with their own challenges that IT teams need to be prepared to address.

For example, today’s leading platform in regulatory information management Veeva introduces three product releases per year where the RIM Vault is enhanced with new features. Compared to historic on-prem solutions that started to become out of date the month after purchase, this is a fantastic capability. The challenge now is that new features, bug fixes, and enhancements are automatically turned on and/or configurable and have a critical go-live date regardless of whether the organization is ready. The volume of changes can be significant, and some organizations fall behind in implementing the configurable features. In addition, many configurable features are not immediately beneficial but are utilized to build a foundation for future innovations that provide additional efficiencies.

Security can be another significant challenge. An overly complex security scheme can stunt the utilization of the solution, preventing the use of features and functionality intended to provide significant user efficiency. A properly configured and maintained RIM solution should allow all its users to easily find the information necessary to complete current Regulatory tasks. Often, during solution implementations, an organization will try to configure a security scheme that is far too granular, complex, and not conducive to efficient collaboration. The overly complex security will cause frustration and loss of user adoption of the solution. It can also cause burdensome administrative overhead and limit the available scope of change requests from the user community.

The Solution – HealthCheckAssist

Implementing your RIM solution took time and money. As an experienced regulatory information management solution provider and proven migration, technology, and services partner on the Veeva platform, fme is ready to help our clients make the most of their investments. We are proud to introduce HealthCheckAssist, a comprehensive service solution meticulously designed for users of Veeva Vault RIM.

In the often-convoluted landscape of regulatory information management, HealthCheckAssist is a surgical toolbox of optimization, offering a suite of services tailored to dissect and enhance the intricate mechanisms of Vault RIM. Through in-depth stakeholder interviews and system analysis, HealthCheckAssist delves into different departments’ unique needs and challenges to develop a complete streamlining and optimization pathway that aligns perfectly with organizational objectives.

In the dynamic environment of regulatory information management, features and functionalities evolve rapidly. A standout feature of HealthCheckAssist is its rigorous review of new feature capabilities. This ensures that your organization remains at the forefront of the latest changes, leveraging the latest updates to streamline processes and enhance efficiency.

Moreover, HealthCheckAssist strongly emphasizes manageable security, with comprehensive assessments to safeguard critical regulatory data, ensure proper accessibility, and promote effective information exchange and collaboration. Shifting the focus to a manageable and sufficiently open security model is a cornerstone of any robust regulatory information management strategy. Properly executed, this security approach eliminates over-engineered access schemas and protects your information and users in an age where data breaches can have catastrophic consequences.

Benefits of HealthCheckAssist

The benefits of HealthCheckAssist are multifaceted. Organizations can expect a significant uplift in data and document quality, driven by optimizing the features and functionalities of Vault RIM. This enhancement in data and document quality is not just about accuracy; it’s about ensuring that your regulatory information is comprehensive, up-to-date, and readily accessible, facilitating swift decision-making and compliance processes.

HealthCheckAssist also includes access to fme’s unique professional administration tool for the Veeva platform, dqMan. With dqMan, HealthCheckAssist dramatically reduces the need for manual intervention and automates and optimizes key processes to free up valuable resources. Your team can focus on strategic initiatives rather than getting bogged down in routine data and document management tasks. This shift boosts productivity and enhances job satisfaction among team members, who can engage in more meaningful and impactful work.

The strategic advantage offered by HealthCheckAssist cannot be overstated. In the competitive regulatory compliance landscape, staying ahead requires keeping pace with regulatory changes and preempting them. HealthCheckAssist empowers organizations to do just that, providing a competitive edge that can make all the difference in a competitive and highly regulated industry.

Conclusion

HealthCheckAssist by fme is not just a solution; it’s a strategic partnership in your journey through the complexities of regulatory information management. Its comprehensive suite of services focuses on optimizing Vault RIM and make it an indispensable tool for any organization looking to excel in regulatory compliance.

We invite you to contact us to learn more about HealthCheckAssist’s transformative potential for your organization. Discover how it can streamline your regulatory information management processes, enhance both data and document quality, and provide a strategic advantage in the fast-paced world of regulatory compliance.

Added Bonus – Veeva Vault Edition of dqMan

As an additional bonus, we will also include a single-user annual license for dqMan as part of the engagement.

dqMan is 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.

Seamless Integration: Transforming CRO to Sponsor Data Transfers with fme and JiT

Seamless Integration: Transforming CRO to Sponsor Data Transfers with fme and JiT

In the dynamic realm of clinical research, the partnership between fme and Just in Time GCP (JiT) emerges as a beacon of innovation, particularly with their recent unveiling of CROAssist. This collaboration is not just a merging of two entities; it’s a fusion of expertise and technology to redefine the landscape of Trial Master File (TMF) management in clinical trials.

The inception of CROAssist™ is a testament to the forward-thinking approach of both JiT and fme. JiT brings to the table its unparalleled expertise in risk-based TMF management approaches, which are crucial for maintaining compliance and ensuring inspection readiness. On the other hand, fme contributes its vast experience in system migrations, a critical aspect in the seamless data transfer across platforms.

Automated Transfer of Trial Data from CRO to Sponsor

The core of CROAssist’s innovation lies in its ability to automate the transfer of trial data from Contract Research Organizations (CROs) to sponsor systems like Veeva Vault eTMF. This automation is a game-changer, addressing the traditional pain points of TMF management, such as data integrity, standardization, and compliance with regulatory standards. By minimizing human intervention, CROAssist significantly reduces the risk of errors and inconsistencies, ensuring that the TMF is always audit-ready.

Beyond automation, CROAssist stands out for its comprehensive TMF strategy. It’s not just about transferring data; it’s about transforming how it is managed, analyzed, and utilized. The platform employs sophisticated algorithms and artificial intelligence to enhance data integrity and compliance. These advanced technologies enable a proactive approach to TMF management, identifying potential issues before they become significant problems.

Benefits of CROAssist

The benefits of CROAssist extend beyond operational efficiencies. By streamlining TMF management, the platform enables sponsor organizations to focus more on the scientific aspects of their trials, rather than being bogged down by administrative tasks. This shift in focus can lead to faster trial completions, quicker time-to-market for critical medications, and ultimately, a more significant impact on patient health.

The partnership between JiT and fme, culminating in the creation of CROAssist, is a reflection of a broader trend in the pharmaceutical industry towards collaboration and technological innovation. In a sector where the stakes are incredibly high, with patient health and safety at the forefront, such innovations are not just welcome; they are essential.

The significance of CROAssist goes beyond its technical capabilities. It represents a paradigm shift in TMF management, where technology and expertise converge to create a more efficient, reliable, and compliant clinical trial environment. As the industry continues to evolve, partnerships like that of JiT and fme, and solutions like CROAssist, will be critical in navigating the complexities of clinical research, ensuring that life-saving treatments can be delivered to those in need more swiftly and safely than ever before.

QUICKFACTS

  • Efficient TMF Management: Automates and streamlines Trial Master File processes.
  • Management: Seamlessly coordinates data between sponsors and CROs.
  • Integration with Veeva Vault eTMF: Ensures validated data import for enhanced integrity.
  • Operational Burden Reduction: Alleviates complex TMF tasks from businesses.
  • Scalable Solution: Adapts to varying trial sizes and complexities.

In conclusion, the collaboration between JiT and fme and their development of CROAssist is a shining example of how strategic partnerships and technological advancements can address longstanding challenges in clinical trials. As this partnership continues to bear fruit, the industry can look forward to a future where TMF management is no longer a hurdle but a facilitator of scientific discovery and medical breakthroughs.

Learn More About CROAssist

Whether you are a sponsor or a CRO, the efficiency and accuracy gained through CROAssist will streamline your data transfer and minimize the obstacles to your trial’s success. Learn more at the SCOPE Summit for Clinical Trial Executives, or contact us directly to get all the details on CROAssist and how this new approach to TMF management can benefit your patient health and business goals.

Will we see you at DIA RSIDM 2024?

Will we see you at DIA RSIDM 2024?

Will you be attending DIA RSIDM 2024 in Bethesda, MD in February? This annual event is the premier gathering for professionals working in the pharmaceutical, biotechnology, and regulatory industries, focusing on the critical aspects of submissions, information management, and document compliance.

The importance of operational efficiency across the full process and technology environment that enables the management of regulatory information cannot be understated. It is vital to provide timely, quality regulatory submissions to health authorities in order for drug companies to accelerate the delivery of therapeutics and vaccines to their patients. At DIA’s Regulatory Submissions, Information, and Document Management (RSIDM) Forum, industry and regulatory stakeholders collaborate to examine current and evolving data standards and requirements and effective regulatory information management approaches to align related people, processes, and technology.

If you’ve attended in the past, the 2024 Forum includes a refreshed set of tracks and focus areas that will provide invaluable insights on how to build and sustain successful RSIDM foundations, optimize their current processes and procedures, adopt innovative technologies, and achieve regulatory excellence. You’ll also have ample opportunities for networking, knowledge sharing, and education for both business and technology-focused topics at all levels.

Connect with fme’s David Gwyn at DIA RSIDM 2024

This year, fme’s own VP of Business Consulting David Gwyn will be attending DIA RSIDM @presenting and contributing to the many discussions with industry and regulatory stakeholders covering the effective strategies to align related people, processes, and technology for business success.

Use the contact form below to get connected before the event, or make plans to join his session on February 14:

Leveraging Structured Content Authoring in Regulatory Submissions: Real-World Experience, Industry Insights and Tools
View Session >>
Feb. 14, 8:30am
Bethesda North Marriott Hotel and Conference Center
Brookside (Lower Level)

Other Essential Sessions

If you haven’t reviewed and selected your sessions yet, here are just a few we feel are worth the time to attend. Hope to see you there, and let us know if you have any questions on these topics!

Fostering Trustworthy and Responsible AI
View Session >>
Keynote Address
New and emerging technologies like AI have undeniably proven their potential in optimizing processes, improving decision-making, and enhancing the collection and management of data across the lifecycle. Reggie Townsend, VP of Data Ethics Practice at SAS, will share insights on how AI and other emerging technologies can be responsibly leveraged in regulatory affairs and operations.

The Future of Regulatory Submissions: Innovation of the Possible using a Non-disruptive Framework
View Session >>
Technology may be disruptive and revolutionary but must be introduced in a non-disruptive way to a highly regulated environment. Innovation within the CTD / eCTD v4.0 framework including cloud computing provides exactly this vehicle for change.

Shaping and Overseeing Regulatory Strategy, Operations, and Vendor Relationships
View Session >>
Enable high-quality relationships between clients and vendors in the regulatory submissions space, and successfully shifting from a vendor-based RIM model to an in-house operation. We will also delve into acquisitions and mergers/partnerships as they relate to strategy and execution in submissions operations.

So, You Think Technology Solutions are Failing your Content Transformation? Did You Set Them up for Success?
View Session >>  
The most successful intelligent automation implementation teams think content before software: a software-agnostic mindset is key to success. This session will discuss how applying a software-agnostic methodology can supports effective content transformation across people, processes, technology, and data/content.

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

Modernize and Accelerate Validation Processes

Modernize and Accelerate Validation Processes

The speed at which software and computer technology are advancing is accelerating at an astounding pace. But in highly regulated industries like life sciences, strict requirements slow the pace of system innovation and can add substantial costs to any efforts to adopt new and improved solutions. Of course, these requirements’ underlying and essential purpose is ensuring that the software performs as expected. Still, there have been times when the rigidly comprehensive Computer Software Validation (CSV) approach has triggered a whole raft of testing and documentation for even small tweaks to an IT system.

CSA is accelerating validation for modern business

This overzealous requirement is one of the main reasons the life sciences sector is reticent to adopt new technology, hindering improvements across the industry. To help address this issue, the FDA is developing new guidance that promises to reduce software assurance and documentation’s time and cost burden by as much as 80%. Still in draft, the new risk-based Computer Software Assurance (CSA) approach is focused on the impact of any changes on the product or patient safety. Testing and associated documentation are adjusted according to the perceived risk, introducing new concepts of ad-hoc testing, not testing low-risk requirements and relying on vendor-performed testing as part of the overall validation effort.

Learn more about CSA on September 6

It might be another year before the new provisions are fully approved and adopted, but knowing that the FDA is altering its approach to software assurance paves the way for bolder tech-based ambitions. The advantages of CSA over traditional CSV promise to open new opportunities to accelerate validation processes and encourage Life Science companies to explore and implement new and innovative technologies without being encumbered by burdensome validation requirements.

On September 6, fme’s David Gwyn will be sharing critical insights in a live presentation with Paul Ireland, VP Life Sciences at DocShifter, entitled “CSV vs. CSA: How to accelerate business speed”. In this session, they will delve into the potential of Computer Software Assurance (CSA) as a tool to accelerate the validation process in line with the pace of modern business operations. They will compare CSA with the traditional Computer System Validation (CSV) approach, discussing its primary limitations, and then explore how the risk-based approach of CSA can potentially overcome these challenges.

As specialists in content and document management in highly regulated life sciences environments, the historic knowledge of Mr. Gwyn and Mr. Ireland is sure to deepen anyone’s understanding of the challenges of CSV, and the exciting possibilities of the new CSA guidelines.

Use the link below to learn more and sign up to attend this unique LinkedIn Live session, and please review fme’s previous posts on CSA, validation challenges, and our newest solution fme compliance-center™.

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

Learn more about CSV and CSA

Learn more about the challenges and new solutions for software validation in this recording from fme’s David Gwyn.