fme AG
fme SRL
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 These systems require extensive maintenance, outdated infrastructure, and manual workarounds, creating silos that limit real-time insights and slow down quality processes.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.