Dot Compliance QMS
Dot Compliance provides the industry’s first off-the-shelf QMS solution – ready to deploy from day one, with little to no setup required, while also incorporating industry best practices and standards that address the latest global regulatory requirements.
Powered by the Salesforce.com platform, our solutions enable life science organizations to quickly digitize their quality and compliance processes including Document Management, Training Management, Change Control, CAPA, Customer Complaints. Compliant with 21 CFR part 11, EU-Annex 11 and support ISO 9001, 13485, 14971, 27001 & MORE!
Processes included:
▶ Document Management
▶ Training Management
▶ Quality Event Management
▶ CAPA Management
▶ Change Management
▶ Complaint Management
▶ Audit Management
▶ Supplier Quality Management
▶ Risk Management
▶ Design Control
▶ Deviations/Non-conformances
✔ Seamless Install
✔ Cost Effective
✔ One-Stop-Shop
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DC-E DigitalClone for Engineering
DigitalClone® for Engineering is the world's only gearbox reliability prediction solution integrating multiple scales of analysis in a single software package. In addition to modeling and analysis capabilities at the gearbox and gear/bearing levels, DC-E is the only solution available that models fatigue life based on detailed, physics-based models of the material microstructure (US Patent 10474772B2).
DC-E enables construction of a gearbox digital twin with high value across all stages of the lifecycle of the physical asset - from design and manufacturing optimization to component supplier selection to failure root cause analysis to condition-based maintenance and to prognostics. This computational environment drives down the time and cost to bring new designs to the market and to sustain them over time.
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Elementum
Track deductions, identify root causes, collaborate with partners, and hold everyone more accountable. Supply chain exceptions are inevitable. Wasting endless resources on them is not. Enable your team to work seamlessly with carriers and suppliers to find and close gaps. Track Key Issues & Value at Risk Analyze Root Causes & Resolutions Collaborate with Suppliers & Partners. Direct Actions to Resolve Incidents Assign to Internal or External Users Set Due Dates & Get Reminders. Elementum is the company behind the first cloud-native supply chain automation platform. In an age where instant gratification is the new norm and customer expectations are continuing to grow exponentially, successful operations need to adapt faster than ever to unplanned exceptions. Elementum’s platform centralizes information and communication to drive rapid resolution of incidents, enable cross-ecosystem execution, and ensure products are available at the right time, place, quantity, and cost.
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MediaLab Intelligent Quality Engine (IQE)
IQE is MediaLab’s non-conforming event management system that allows clinical laboratory teams to track, assess, and prevent non-conforming events (NCE). With the capability to import or create event forms and data logs, IQE enables laboratory teams to eliminate deficiencies, correct common NCEs, and, most importantly, focus on improving healthcare. With a MediaLab institutional subscription, administrators can easily document each phase of the event management lifecycle, from initial event description to risk analysis, investigation, and root cause analysis, corrective and preventive actions plans, and overall CAPA effectiveness evaluations.
IQE supports:
• Customizable, pre-built event forms and workflow
• Monitoring and evaluating change control events, failed PT events, customer complaints / feedback, safety / injury events, supplier / vendor issues, and more
• Tracking periodic data entries
• Robust reporting and dashboards to identify common NCEs and CAPA effectiveness
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