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LEGACY QMS REPLACEMENT

Your Legacy QMS is holding you back. It's time.

Smarteeva replaces rigid, expensive legacy quality management systems with an AI-powered, Salesforce-native post-market surveillance platform that your team can actually configure, your IT organization can actually manage, and your quality professionals can actually enjoy using.

Trusted by 450+ MedTech companies of every size

Why Legacy Systems Become Liabilities

You already feel it. Let's name it.

The Cost Problem

Your legacy QMS doesn't just cost you the licensing fee. It costs you the annual maintenance contract. It costs you the professional services engagement every time you need a workflow change. It costs you the validation resources required for every upgrade. It costs you the productivity your team loses working around the system's limitations. And it costs you the opportunity - the innovations you can't pursue because all your resources are consumed keeping the old system running.
When you add it all up, licensing, maintenance, customization, validation, IT infrastructure, lost productivity, and shadow processes - most organizations find their legacy QMS costs two to three times what they expected. And the cost goes up every year, not down.

The Rigidity Problem

Legacy quality systems were built to be configured once and run forever. That worked when regulatory requirements changed slowly, and complaint processes were relatively static. It doesn't work when EU MDR introduces new PMS reporting requirements, when the FDA changes MDR expectations, when your organization acquires a new product line, or when your quality team needs a new field added to the complaint form.
In a legacy system, any of these changes requires a scope assessment, a change request, a vendor quote, a project timeline, development work, testing, validation, and deployment. What should be a two-day task becomes a two-month project. So your team doesn't ask for the change. They build a workaround instead. And the workarounds accumulate until the system barely reflects how your team actually operates.

The Technology Problem

Legacy QMS platforms were built on technology stacks that are now generations behind the current state of enterprise software. Proprietary databases that don't integrate easily. On-premise or single-tenant architectures that require IT infrastructure management. User interfaces were designed in an era when "usability" wasn't a priority.
These platforms weren't designed for AI. They weren't designed for real-time analytics. They weren't designed for mobile access. They weren't designed for the kind of connected, intelligent quality management that modern regulatory expectations demand.
You can add point solutions and middleware to patch these gaps - and many companies do, but every additional layer adds complexity, cost, integration risk, and validation burden.

The People Problem

Your quality professionals didn't go to school to learn legacy software administration. But that's what many of them spend their time on: entering data, running reports, navigating unintuitive interfaces, and maintaining workaround processes. The system should empower your team to do quality work. Instead, it consumes their time with system work.
New hires take months to learn the legacy system. Power users hoard institutional knowledge about workarounds and undocumented processes. And when your Salesforce team looks at the legacy QMS, they see a completely separate technology world that doesn't benefit from the Salesforce skills, tools, and ecosystem they've already invested in.

The Smarteeva alternative

What Changes When You Move to Smarteeva

AI That Makes Your Team Faster: From Day One

Smarteeva doesn't just digitize your existing processes on a new platform. It transforms them with AI. Complaint intake is automated. Risk assessment runs through intelligent decision trees. Adverse events are detected by NLP scanning every complaint narrative. PMS reports are generated in minutes. Investigations start with machine learning-guided intelligence instead of blank forms.

Your team doesn't just move to a new system. They move to a fundamentally more capable way of working.

Salesforce-Native: One Platform, Not Two

Smarteeva runs natively on Salesforce. That means your complaint data lives in the same platform as your CRM and Service Cloud. Your Salesforce administrators configure Smarteeva using the same tools they use for everything else. Your users experience a consistent, familiar interface. And your IT team manages one platform instead of two.

No middleware. No integration layer to maintain. No proprietary database. Just Salesforce, the platform your organization has already invested in, validated, and trained on.

Configurable by Your Team: Changes in Hours, Not Months

Need a new field on the complaint form? Your admin adds it. Need a new workflow for a newly acquired product line? Your admin builds it. Need a new dashboard for the management review? Your admin creates it. Need a new decision tree for risk assessment? Your admin configures it.

Smarteeva is designed to be configured by your team, using standard Salesforce platform tools. No vendor engagement. No professional services. No six-month timelines. Changes happen in hours or days — and your validation approach is simplified because you're validating configurations on a platform your organization already understands.

Lower Total Cost of Ownership

When you eliminate the legacy licensing fee, the annual maintenance contract, the professional services for every change, the IT infrastructure costs, the middleware licensing, the dedicated system administrator role, and the productivity losses from workarounds, the math is clear. Smarteeva on Salesforce and AWS costs less to own, less to operate, and less to maintain than the legacy system it replaces.

And the cost is predictable. Salesforce subscription pricing. AWS infrastructure. No surprise vendor bills when you need a workflow change.

How We Get You There - Without Disruption

Moving off a legacy QMS is a significant undertaking. We know that. We've done it many times, for medical device companies of all sizes, and our team has 100+ years of combined experience in post-market surveillance. Here's how we approach it:

Phase 1:
Assessment & Planning (Weeks 1-3)

 We map your current complaint workflows, data structures, regulatory requirements, and integration points. We identify what should be replicated in Smarteeva, what should be improved, and what can be eliminated. You get a detailed migration plan with timeline, resource requirements, and risk mitigation strategies.a

Phase 2:
Configuration & Data Migration (Weeks 4-8)

We configure Smarteeva for your specific workflows, product families, and regulatory requirements. Historical complaint data, adverse event records, and quality data are migrated with full integrity validation. Your team validates the configuration against your quality requirements.

Phase 3:
Parallel Operation & Validation (Weeks 9-10)

Smarteeva runs alongside your legacy system for a defined parallel period. Your team validates data accuracy, workflow correctness, and reporting integrity. Issues are identified and resolved before cutover.

Phase 4:
Go-Live & Legacy Decommission (Weeks 11-12)

Smarteeva becomes your system of record. Your team is trained and supported through the transition. The legacy system is decommissioned. And your quality team starts operating on a platform that actually empowers them to do quality work.

Full Operational

Most organizations are fully operational on Smarteeva within 12 weeks. For complex, multi-site, multi-product deployments, we build a phased plan that manages risk while maintaining momentum.

Questions?

We’re glad you asked.

How long does a legacy QMS migration typically take?

Most organizations are fully operational on Smarteeva within 12 weeks. Complex, multi-site deployments may take longer, with a phased approach that manages risk and maintains regulatory continuity.

What happens to our historical data?

Smarteeva's migration team transfers historical complaint data, adverse event records, and quality data with full integrity validation. Your regulatory history is preserved and accessible in the new system.

Do we need to revalidate our quality system when moving to Smarteeva?

Yes, as with any quality system change, validation is required. However, because Smarteeva runs on the standard Salesforce platform, many organizations find that their validation approach is simplified, leveraging existing Salesforce validation frameworks and focusing on configuration-specific testing.

What if we have significant customizations in our current system?

During the assessment phase, we review all customizations and determine the optimal approach for each, replicate in Smarteeva configuration, redesign for better efficiency, or retire if no longer needed. Our goal is to move your processes forward, not simply copy legacy limitations onto a new platform.