What is Dot Compliance?
- Founder & CEO: Doron Sitbon
- Founded: 2015
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Use Cases:
- Managing GMP-compliant document control and CAPA processes for pharmaceutical companies
- Ensuring ISO 13485 compliance for medical device manufacturers
- Overseeing quality and regulatory workflows in biotechnology and clinical research organizations.
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Technology:
- Built entirely on the Salesforce platform for scalability and integration
- Features an AI assistant named Dottie for compliance insights
- Pre-validated modules aligned with 21 CFR Part 11, EU Annex 11, and ISO standards
Dot Compliance is an AI-powered compliance solution aimed at simplifying and automating quality, compliance, and regulatory management for organizations in life sciences. Dot Compliance is created on the Salesforce platform and provides an electronic Quality Management System (eQMS) that is suitable for life sciences organizations, with ready-to-use modules for quick setup and easy upkeep to maintain compliance. Dot Compliance provides robust document management, CAPA, audits, and supplier quality tools integrated into a single system. The AI features and automation in Dot Compliance help reduce manual mistakes, improve workflow efficiency, and speed up the time it takes for regulated companies to bring products to market. Dot Compliance is designed to provide operational excellence for pharmaceutical, biotech, and medical device companies so they remain inspection-ready.
Key Features
Dot Compliance's key features are
- Centralized document management with version control and audit trails
- Automated CAPA and deviation management workflows
- Complete audit and supplier quality management
- Regulatory management for submission and compliance tracking
- Modular architecture: eQMS Xpress, Compliance Xpand, and Enterprise Xact
- AI-powered insights and analytics for proactive risk management
- Built-in validation packages for compliance readiness
- Integration with ERP, CRM, and productivity tools
Pricing
Dot Compliance has a custom pricing model based on organization scale, number of modules, and deployment considerations. Dot Compliance does not publish exact figures, but a similar enterprise, eQMS, typically charges between $20,000 and $60,000 annually. Businesses can inquire directly from Dot Compliance for personalized quotes according to their compliance and scalability needs:
Disclaimer: For the latest and most accurate pricing information, please visit the official Dot Compliance website.
Who is using Dot Compliance?
A diverse range of users and organizations utilize Dot Compliance
- Pharmaceutical Companies
- Biotechnology Companies
- Medical device manufacturing Industries
- Quality Teams
Alternatives
Some Dot Compliance alternatives are
- Mastercontrol
- Qualio
- Trackwise
- Greenlight Guru
Conclusion
Dot Compliance is a powerful, scalable, AI-enabled eQMS solution built for life sciences, with a modular approach that allows a company to start small and grow over time. All configurations are pre-validated, allowing for the quality management processes to be quick to market and compliant from the first use. Dot Compliance's design works seamlessly with Salesforce to handle all regulatory tasks automatically, reducing the need for manual work, lowering the risk of compliance issues, and speeding up innovation in organizations that are regulated. It is a great choice for organizations looking for a digital transformation in quality management and regulatory compliance.
Verified
