Medical Devices

 
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A new era of GMP inspection intelligence

Inspector Tendencies

Understand inspector tendencies and issue rates at the time of inspection, which enables on-site teams to minimize the likelihood of an observation.

Peer Benchmarks

Benchmark performance relative to your peer group, which creates the business case for preemptive corrective actions.

Supply Chain Monitoring

Evaluate risk of new suppliers / CMOs and monitor existing supplier risk levels.

Lower Costs

Reduce/eliminate resources and development costs to collect, perfect, update and manage FDA data.

Ace your next inspection

Understand inspector history and tendencies. Get instant access to 483s, Warning Letters, CFR citations, and key areas of focus.

Determine site-level risk

Understand site-level history and enforcement actions. Get instant access to 483s, Warning Letters, CFR citations, and key issues it has been cited for. Get notifications for inspection activity and automatically request key inspection documentation, like EIRs and 483s.

Analyze FDA trends

Be one step ahead of the FDA by determining key areas of focus. Align your budget and CAPAs to the top issues and emerging trends.
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