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. Dot Compliance is fully validated & compliant with 21 CFR part 11, EU-Annex 11 and support ISO 9001, 13485, 14971, 27001 & MORE! ▶ Document Management – Capture, track and store all your documents in one place. Our capabilities include Part 11 Compliant e-signatures, approval workflow, revisions control and more. It easily integrates with other QMS business processes providing a closed loop system. ▶ Training Management - Manage end-to-end employee training from record management, course distribution and completion, and escalation. ▶ Complaint Management – Ready to use compliant handling ensures regulatory compliance, enhances product development, mitigates risk, and finds opportunities for growth and innovation by meeting specific customer requirements. ▶ Change Management – Change Control through QMS Xpress offers a standardized process for workflow flexibility, allowing a life sciences manufacturer to manage all types of changes from one centralized platform. ▶ CAPA - Dot Compliance automates CAPA processes to safeguard your organization from regulatory risk, and include integration with other core quality processes such as audit, training, document management, change control, etc. ▶ Risk Management – A proactive and risk-based approach to quality management systems minimizes the chances for undesired effects as well as a continual improvement by predicting potential problems. It also lowers the risk of manufacturing problems that may result in shorter and fewer FDA and EMA inspections. ▶ Deviations/Non-conformance Management – Managing deviations and other quality events is required by GMP. Dot Compliance cloud-based fully validated QMS provides organizations with the ability to manage deviations so they are identified and recorded. This includes Incidents that could affect the quality or the reliability of records or tests to be investigated and resolved. ▶ Supplier Quality Management - Manage, track, and collaborate with suppliers, contract manufacturers, and distribution chain partners across the entire supply chain. Consolidate quality management silos of suppliers, contracted manufacturing organizations (CMO), internal production divisions, and distribution supply chain into one connected quality system.