Quality Archive - FME US, llc

Unlock the Power of Generis CARA for Quality — With fme as Your Proven Migration Partner

by Meghan Carr | Apr 16, 2025 | Generis, Quality, Technology Services

The life sciences industry is redefining what quality means in the digital era. No longer confined to siloed workflows or paper-era processes, modern quality management demands real-time insights, cross-functional alignment, and seamless integration across systems.

That’s why more organizations are choosing Generis CARA, a next-generation platform built not only to modernize quality operations, but to align them with broader regulatory, clinical, and enterprise goals. But reaching that vision takes more than selecting the right platform: it requires executing a migration strategy that ensures business continuity, compliance, and long-term value from effective data usability.

This is where fme delivers.

Why Generis CARA is Gaining Momentum

Generis CARA is rapidly becoming the platform of choice for forward-looking life sciences organizations that need more than just incremental improvements to their quality systems. What makes CARA stand out is its metadata-driven architecture, which enables intelligent workflows, dynamic configurations, and true cross-functional collaboration.

CARA brings quality, regulatory, safety, and clinical processes together in a truly single, harmonized environment, eliminating the inefficiencies of disconnected systems that require manual connectivity and redundant data. The platform’s modern UX, personalized dashboards, and responsive design enhance adoption and usability, while deployment flexibility (including public cloud, private cloud, or on-premise) supports a wide range of IT and compliance strategies.

With built-in interoperability and open APIs, CARA integrates naturally with ERP, LIMS, PLM, and other enterprise systems, helping quality become a connected, agile function across the business. Those who know me, know this is a major sticking point for me – stop duplicating your master data in your QMS when you can integrate with your ERP, please!

Proven Experience with Generis CARA Migrations

fme doesn’t just understand quality systems: we understand how to move them. We are actively supporting some of the world’s most complex and highly regulated organizations as they migrate to Generis CARA today. That firsthand experience gives us a deep understanding of the platform’s architecture, its data model, and the transformation steps required to get from legacy to next-gen, all without compromising compliance.

We combine that expertise with migration-center®, our purpose-built migration platform that enables large-scale data and document migrations with precision and traceability. From structured metadata to unstructured legacy documents, we help organizations classify, map, transform, and verify every record so what arrives in CARA is not only compliant, but clean, usable, and aligned with your business goals.

Our work isn’t theoretical. It’s happening now and delivering measurable value to companies modernizing their global landscapes with CARA.

What fme Brings to the Table

Making the move to a new QMS platform is a high-stakes endeavor. fme brings the tools, expertise, and industry knowledge to ensure that the migration isn’t just successful, it’s designed in line with your organization’s strategic goals. That means not only preserving compliance and continuity, but also structuring your data to support future innovation.

Whether you’re building a foundation for AI-driven quality insights, enabling advanced trend analysis, or preparing for greater integration across enterprise systems, we ensure your migration delivers usable, intelligent, and value-rich data that is ready to power what’s next. Here’s what you can count on fme for:

End-to-end CARA migration services, from legacy system analysis with our Migration Readiness Evaluation and Data Quality Assessment offerings to migration execution to legacy system decommissioning and archiving
Accelerated execution through reusable templates, automation frameworks, and proven methodologies from hands-on migrations into CARA
Change-aware transformation, built to preserve compliance history and improve future usability

We don’t just move data, we move the right data, in the right format, with the right controls to support your next-generation quality operations.

The Right Platform. The Right Partner.

Generis CARA is changing the way quality systems work. fme ensures you get there the right way: confidently, compliantly, and with a migration strategy designed to deliver value from day one.

Let’s talk about your path to Generis CARA. Download the datasheet below to learn more about fme’s capability with the Generis CARA platform, and request a personalized discovery discussion.

Download fme's Generis Capabilities Datasheet

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

by The fme Team | Apr 15, 2025 | Business Consulting, Quality

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.

Learn more about SelectAssist for Quality

Moving Beyond Legacy: How fme Delivers a Proven Path to Veeva Vault Quality

by Meghan Carr | Mar 6, 2025 | Content Migration, Quality, Technology Services, Veeva

Quality is the foundation of everything in life sciences—it ensures product safety, regulatory compliance, and ultimately, patient well-being. Yet, many companies are still relying on legacy QMS platforms built for a different era. These systems require extensive maintenance, outdated infrastructure, and manual workarounds, creating silos that limit real-time insights and slow down quality processes. Instead of enabling proactive quality management, they introduce operational inefficiencies and compliance risks. As regulatory expectations evolve, the industry is shifting toward connected, digital quality ecosystems—where agility, compliance, and informed decision-making are no longer optional but essential.

Why Veeva Vault Quality?

Veeva Vault Quality provides a modern, scalable solution that eliminates fragmented systems and manual handoffs, ensuring end-to-end quality management. From document control and training to deviations, CAPAs, change control, audits, and supplier quality, Veeva offers seamless traceability across all quality processes, helping life sciences companies accelerate product development and manufacturing while maintaining compliance. But choosing the right platform is only part of the equation, executing the migration workstream effectively is critical.

The Reality of Migrating to a New QMS

Migrating from a legacy, highly customized QMS to a configurable, low or no-code digital solution is never as simple as just moving data. While buzzwords may make it sound easy, the reality is that every migration comes with complexities, some small but most significant.

Legacy QMS platforms have been embedded in business operations for years (sometimes decades) and customized to fit unique workflows, integrations, and automation rules. These configurations don’t always translate cleanly into a new system designed around industry best practices rather than one organization’s unique way of working. And some of these are truly unique.

For life sciences companies, the risks of getting this wrong are high. Quality systems aren’t just about efficiency; they’re the backbone of regulatory compliance. Every deviation, CAPA, audit trail, and training record must be migrated accurately and remain fully intact for regulatory inspections. For companies managing a high volume of complaints, visibility into what happened, how it was investigated, and how it was corrected is essential. Compliance isn’t something that can be recreated after the fact: it must be preserved throughout the migration.

And then there’s data complexity. Legacy QMS platforms often contain years of unstructured records, inconsistent metadata, and outdated information mixed in with critical, real-time quality data. A simple lift-and-shift isn’t an option—without careful mapping and transformation, organizations risk losing valuable insights or, worse, compromising compliance.

Beyond the technology, people and processes play a critical role. Quality teams have spent years working within the legacy system, and the thought of starting over in a new one can create real resistance. Even when the new system is objectively better, users often push back if they feel it disrupts their daily operations, especially if they haven’t been actively engaged in designing the future-state process. Change management isn’t just about training on a new interface, it’s about ensuring that users understand how the new system supports their responsibilities and makes their jobs easier.

And let’s not forget integrations. QMS platforms don’t operate in isolation; they connect to ERP systems, regulatory platforms, MES, training systems, and more. If these connections aren’t carefully managed, a migration intended to improve efficiency can introduce new bottlenecks and risks.

Why fme Is the Only Partner To Trust With This Critical Workstream

This is exactly where fme thrives. We’ve spent years working with global life sciences companies to execute highly regulated, complex data and document migrations, ensuring that critical business processes remain uninterrupted and compliance isn’t compromised. We don’t just migrate data and documents: we assess, classify, transform, and verify it, ensuring that what arrives in the new system is clean, complete, and audit-ready.

Unlike general IT consultancies that offer migration as just a big part of their bag of tricks, fme specializes in highly regulated data and document migrations. We’ve led some of the largest, most complex migrations in the industry, working with pharmaceutical and biotech leaders to modernize their quality, regulatory, and clinical systems without disruption. Our experience gives us the foresight to proactively mitigate risks before they become obstacles, whether it’s aligning legacy data structures with modern regulatory requirements, handling complex document relationships, or ensuring seamless integrations with connected systems.

We combine our deep industry expertise with migration-center®, a Veeva product-certified migration technology, to drive transformation, execution, and validation with speed and precision. While technology alone isn’t enough, migration-center enables us to execute migrations efficiently, with full traceability and regulatory alignment, ensuring that:

Data integrity is maintained. Every piece of critical information remains accurate, complete, and compliant throughout the transition.
Business disruption is minimized. Our structured, real-world-tested approach ensures that operations continue seamlessly while data moves.
Regulatory compliance is preserved. We ensure all migrated data adheres to industry-specific guidelines, keeping your organization inspection-ready.
Data usability is improved. We don’t just transfer data; we structure and optimize it for maximum usability in Veeva Vault.

Quality isn’t just what we help our clients maintain: it’s how fme operates. Our ISO/IEC 27001-certified QMS and ISO 9001:2015 certification reflect our internal commitment to excellence, compliance, and security. The world’s leading life sciences companies trust fme to handle their most critical quality document and data migrations because we bring the right expertise, the right technology, and the right mindset to every project.

Take the Next Step Toward a Seamless, Compliant, and Efficient Quality Migration

Your quality data and documents are too important to leave to chance. Download our datasheet to explore fme’s end-to-end Veeva Vault capabilities and see how our expertise can support your transition. Ready to discuss your specific challenges? Connect with our experts today—we’ll work with you to develop a migration strategy that ensures data integrity, regulatory compliance, and business continuity.

Let’s get your digital transformation right the first time. It’s fme you love to work with.

Download our Veeva Capabilities Datasheet

Additional Resources

Transforming Your Quality Management System Selection with SelectAssist℠

by David Gwyn | Aug 14, 2024 | Business Consulting, Datasheet, Life Sciences, Quality

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.

Download Datasheet

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.

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