# Your Team Is Too Talented to Spend Their Time on Data Entry

Smarteeva gives your quality team complete visibility into every complaint, adverse event, investigation, and quality trend, while AI handles the manual work that's consuming their capacity.

Trusted by 450+ MedTech companies of every size

The problem

## Your tools are forcing skilled quality engineers, analysts, and investigators to spend 40% of their time on data entry, report assembly, and system administration. That's not a people problem. It's a tools problem.

[**Every step requires manual input**](/content/solutions/quality-leaders#/index.html)

Legacy systems don't classify complaints automatically, detect adverse events, or extract data. Every field is a human task. Every record is a manual entry.

### Quality trends discovered too late

Without continuous monitoring, patterns emerge during management reviews or audits, not before them. By then, the window for early intervention has already closed.

[**PMS reports built by hand**](/content/solutions/quality-leaders#/index.html)

Data assembly, formatting, cross-referencing across systems. Your most experienced people are doing work that software should handle.

## The result isn't just a faster process. It's a fundamentally more capable quality operation.

AI handles what doesn't need humans

Intake, classification, triage, data extraction, report generation, trend detection, all automated so nothing waits on a manual step.

Your team focuses on what does

Root cause analysis, corrective action, regulatory strategy, and continuous improvement. The work that actually requires expertise.

Visibility across everything, in real time

Every complaint, every adverse event, every investigation, every quality trend, visible in one platform without building a report to find out.

Global compliance, one platform

FDA 21 CFR Part 803, EU MDR Vigilance, UK MHRA, Canada MDR, PMDA — Smarteeva handles multi-region regulatory reporting without multiple systems or manual format translations.

Scales with your portfolio

Whether you manage 10 device families or 200, Smarteeva handles growing complaint volumes and expanding regulatory obligations without adding headcount or custom configuration.

## The capabilities quality leaders actually need

### Real-Time Visibility Across Your Entire Quality Landscape

Smarteeva gives you a single dashboard view of every open complaint, every active investigation, every pending adverse event report, every CAPA, and every emerging trend across all products, all sites, and all regions.

### AI That Amplifies Your Team's Expertise

Smarteeva's AI removes the obstacles that prevent your quality professionals from doing their best work. Complaints are pre-classified and risk-scored before your team sees them.

### Predictive Quality Intelligence

Smarteeva's predictive analytics detect emerging complaint trends, identify anomalous patterns, and surface early indicators of potential systemic issues before they become audit findings, product actions, or patient safety events.

### Scalability Without Proportional Headcount Growth

With Smarteeva, AI-powered automation means your team's capacity scales with the platform, not with hiring.

### Measurable, Defensible Quality Metrics

Every action in Smarteeva generates operational KPIs that demonstrate your team's effectiveness.

## The metrics that matter to you

### Your Priority

- Complaint resolution time
- Team productivity
- Adverse event detection
- PMS report preparation
- Audit readiness
- Trend detection

### What Smarteeva Delivers

- Reduced by up to 70%
- 40% faster across all PMS workflows
- AI scans every narrative — events caught earlier
- 100+ hours → 8 minutes per report
- 100% complete audit trail, always current
- Real-time, automated, predictive

## Questions?

**Is Smarteeva listed on the Salesforce AppExchange?**

Yes. Smarteeva is certified on the Salesforce AppExchange, meeting Salesforce's security review and quality standards.

**Can our Salesforce admin manage Smarteeva without specialized training?**

Yes. If your admin can configure Salesforce workflows, objects, reports, and page layouts, they can configure Smarteeva.

**Does Smarteeva work with Salesforce Service Cloud?**

Yes. Smarteeva integrates natively with Salesforce Service Cloud.

**What Salesforce editions does Smarteeva support?**

Contact us for current Salesforce edition compatibility and licensing requirements.
