Dot Compliance

About Dot Compliance

Dot Compliance offers the industry's first ready to use Quality Management Solution powered by the Salesforce.com platform. The Dot Compliance Suite includes an extensive set of off-the-shelf ready eQMS and compliance pre-configured best practice processes, enabling customers to deploy quickly and cost effectively.
Dot Compliance ready to use solutions include full project validation services and product validation packages. Our solutions are trusted by many life sciences companies worldwide and by thousands of users. We are fully compliant with 21 CFR part 11, EU-Annex 11 and support ISO 9001, 13485, 14971 and 27001.

Dot Compliance is a platform that helps life science companies manage pre or post-market quality processes including CAPA, change control, training, document control, batch records, and more. Features include workflows, compliance dashboards, big data integration, AI, audit management, and more.

With Dot Compliance, users have access to pre-engineered and pre-validated quality management processes enabling cross-organization visibility, insights, and trend tracking for data-driven decision making. The platform uses machine learning, big data technology, and AI (artificial intelligence) to provide users with predictions and recommendations for quality management improvements.

The Dot Compliance platform ensures companies are audit-ready with features such as document management, training management, corrective and preventive action (CAPA), risk management, and supplier quality management. Additionally, cross-organization processes such as batch and design control, equipment and maintenance management, clinical trials, and enterprise application integration can be managed in the platform, as well as regulatory affairs and audit management.

Ready to use solutions include:

▶ 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 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.