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Automatic creation of events from 3rd party CRM systems (e.g. SAP, Oracle) |
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Automatic assignment based on CRM data |
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Product and patient information is automatically looked up from existing systems |
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Related events are automatically looked up and displayed |
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Integrate with 3rd part CRM systems (e.g. SAP, Oracle) |
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Automatically notify affected departments and personnel |
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Automatically load product, patient and customer information |
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Issue and track RMA and samples |
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Form letter templates for various types of correspondence |
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Create and assign multiple action items to accelerate resolution |
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Easily configurable workflow to automate review and approval process |
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Graphical workflow presentation |
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Intuitive workflow display to show document status |
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Decision trees are configured out of the box (e.g. MDR, ADI) |
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Additional product specific decision trees can easily be configured |
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Force creation of regulatory reports based on user definable conditions |
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More then 40 regulatory forms (e.g. MedWatch, MHRA, MedSafe) |
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Automatic PDF Conversion |
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Record initial assessment results |
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Option to close appropriate events at this stage |
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Perform risk assessment using two, three or four dimensions |
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Automatic risk calculation and results based on your policies |
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Display decision guidelines based on calculated risk level |
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Risk mitigation history |
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For confirmed adverse events initiate a full investigation |
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Event data will be automatically inherited into investigation |
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Dual link between event and investigation |
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Automatically launch investigation action plan activities and assignments |
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Automatically lookup and display related investigations |
