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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ReliaSoft
ReliaSoft software provides a powerful range of reliability software solutions to facilitate a comprehensive set of reliability engineering modeling and analysis techniques. We are the leading reliability solution provider for product test, design, maintenance strategy and optimization.
Our products support a wide range of reliability and maintainability analysis techniques, such as life data analysis, accelerated life testing, system modelling and RAM analysis, reliability growth, FRACAS, FMEA and RCM analysis to meet and improve reliability of your products, processes and optimize maintenance planning.
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DataLyzer FMEA
For manufacturers worldwide, FMEA has become critical in avoiding risk and minimizing quality cost. DataLyzer FMEA links DFMEA, Process Flow, PFMEA, Control Plan. From Control Plan the SPC setup can be automatically created.
Many features are available like reference or Foundation FMEAs, different criteria or classification sets, full authorization, Document and issuing control, Action management, Ballooning import, Automatic translation, Reporting, ITAR configuration etc etc
DataLyzer® FMEA is one of the modules in the DataLyzer software suite. The program closely follows the methodology defined in VDA AIAG and RM13004. DataLyzer FMEA can operate as a stand-alone module or link to DataLyzer SPC software.
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SimplerQMS
SimplerQMS offers a cloud-based Quality Management Software that is fully validated according to GAMP5 and specifically designed for the Life Science industry.
This comprehensive QMS platform helps ensure compliance with various regulatory requirements, including FDA 21 CFR Part 11, EU Annex 11, GxP, cGMP, GAMP 5, GDPR, EU IVDR & EU MDR, ISO 13485:2016, 21 CFR Part 820, ICH Q10, and others.
The software offers a wide range of Life Science QMS modules, such as Document Control, Change Management, Training Management, Supplier Management, Complaints Management, Non-Conformance and Deviation Management, CAPA Management, Audit Management, Technical Documentation Management, Risk Management, Quality KPIs, among others, ensuring a seamless experience.
SimplerQMS enhances document handling by allowing users to work directly in Microsoft Office applications like Word, PowerPoint, and Excel.
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