QISS Quality Management System

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

QVscribe, QRA's flagship product, unifies stakeholders by ensuring clear, concise artifacts. It automatically evaluates requirements, identifies risks, and guides engineers to address them. QVscribe simplifies artifact management by eliminating errors and verifying compliance with quality and industry standards. QVscribe Features: Glossary Integration: QVscribe now adds a fourth dimension by ensuring consistency across teams using different authoring tools. Term definitions appear alongside Quality Alerts, Warnings, and EARS Conformance checks within the project context. Customizable Configurations: Tailor QVscribe to meet specific verification needs for requirements, including business and system documents. This flexibility helps identify issues early before estimates or development progress. Integrated Guidance: QVscribe offers real-time recommendations during the editing process, helping authors effortlessly correct problem requirements and improve their quality.