Moving off TrackWise? Bring post-market quality to a platform built for it
Smarteeva runs complaints, MDRs, PSURs, recalls and risk in one AI-powered suite on Salesforce. Standard implementation takes 12 weeks, with a parallel run before cutover.
What changes when post-market is the whole product
Three cards, each naming a frustration a quality team has with a legacy system and how Smarteeva handles it. The cards describe Smarteeva only and make no claims about TrackWise itself.
The table compares Smarteeva with a general-purpose QMS setup, never with TrackWise by name, so it makes no claim about a specific competitor product that could be challenged.
Customers file through the FDA ESG NextGen gateway in under 3 minutes.
12 weeks
Standard implementation
Includes validated data migration and a parallel run before cutover.
70%
Faster complaint cycles
Once intake, coding, investigation and reporting sit in one place.
Questions? We’re glad you asked.
How long does it take to move from TrackWise to Smarteeva?
Standard implementation takes 12 weeks in four phases: assessment and planning, configuration and data migration, a parallel run, and go-live. Complex multi-site deployments may take longer, with a phased rollout.
Can we bring our historical complaint data?
Yes. Historical data is transferred in weeks 4 to 8 with full integrity validation, and Smarteeva runs alongside your current system before cutover so your team can check accuracy.
Do we have to replace our whole QMS?
No. Smarteeva can take over post-market work and run alongside your existing eQMS, connecting through standard Salesforce APIs.
Does Smarteeva support 21 CFR Part 11 and validation?
Smarteeva supports FDA 21 CFR Part 11 requirements for electronic records and signatures. Validation documentation comes with the implementation package.
What support do we get after go-live?
A dedicated support team covers the first 30 days. After that, standard support covers technical issues, configuration questions and platform guidance, and Smarteeva updates templates and submission formats when regulations change.
