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Products: Compliance Process Management |
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Event Management System
The following product features are provided by QS Labs' Event Management System.
Each feature has a specific set of functionalities to complete the compliance
lifecycle.
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Adverse Event Management
Captures product complaint, internal product non-conformances, customer inquires, service and repair events. Adverse Event Management allows web-based capture, analysis, and resolution of product-related customer contacts. In addition, AEM provides product safety, compliance monitoring by capturing and managing serious adverse events. Activity escalation allows customizable triggers to automatically classify event reporting to adverse events when death, serious, injury and product malfunctions occur during product use. |
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- Features automatic narrative generation to increase adverse events reporting time
- Checks consistency and discrepancy with built-in alert system
- Classifies reported cases and derivations automatically
- Stores event information, contact history, audit trails, time-stamps, notes, and attachments
- Tracks, manages events with user-intuitive drop down fields, including case number, product, category, parts, assignments, due dates, plus more
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Compliance Portal
Allows users to create personalized dashboards and reports. Provides key staff with the statistical and summary reports needed for trend and statistical analysis. Platform includes
embedded
search function to allow simple keyword search or advance query. Customizes reports with chart options, trend period, product information, and multiple filter functions. Dashboard reports may also be exported to html charts, Adobe PDF, XML, Microsoft Excel, or Microsoft Word formats. |
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- Consolidates complex information in simplified reports
- Provides analytics and insight to key company performance metrics
- Updates key decision makers and employees with real-time data
- Allows standard or customized reports to meet the organizational needs
- Simplifies reporting with report wizard function, empowering users to create customized reports with a few clicks
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Investigation Management
Upon completion of entries for a reported event, the system grants and triggers authorized users to investigate the claim. Investigation Management has embedded questions and decision trees to determine possible product failure, prompt inspection needs, log test results, provide root cause analysis, and allows investigators to attach additional supporting documents. |
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- Creates investigation questions from standardized or customized procedure
- Guides effective, accurate investigations with smart decision tree analysis
- Triggers to other system modules automatically for Adverse Event Reporting, CAPA, or Regulatory Reporting
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Regulatory Reporting
Increase reporting efficiency; reduce time spent on data merge and conversion by creating standard reporting forms online. |
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- Provides extensive catalogue of US and international standard reports. Standard reports include MDR, AER for MedWatch. Upon request, additional reports are available as part of the offering: MDV, MedDRA, PSUR, and CIOMS I, NDA Periodic, IND Safety Update, Yellow Card, BfArM, and VAERS reports.
- Allows Ffast and simple report generation
- Tracks and archives submission reports to trace case submissions
- Automates and shortens reporting processes, send standard reports to regulators, distributors, and other involved parties with a few clicks
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