AI-Powered eQMS for Life Sciences Quality Management

Ensure compliance and bring products to market faster and safer.
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Deep domain expertise

Our team brings decades of combined experience in life sciences quality and compliance.

Scale without limits

Our eQMS grows with you, from core processes to advanced AI-driven quality and compliance.

Accelerate innovation

We pioneered the first ready-to-use eQMS and now lead in safe, effective AI for faster innovation.

Get record time to value 

Our ready-to-deploy eQMS comes pre-built and pre-validated, incorporating industry best practices and key workflows out of the box. This means faster implementation, lower total cost of ownership, and reduced IT risk.

Leverage the power of Salesforce

Dot Compliance eQMS solutions are built on the Salesforce platform and deliver 100% native Salesforce compliance. Salesforce supports more than 100,000 organizations and 220,000 deployed apps providing unmatched flexibility, consistent user experience, operational efficiency, data integrity and security, and scalability.

Meet Dottie, the AI brain of your quality management operations

Dottie is your personal AI quality guide: the industry’s first AI assistant specifically trained on quality management workflows. Hundreds of life sciences organizations trust Dottie to help them strengthen quality processes, save time, and reduce organizational costs and risk.

Built for the life sciences

Dot Compliance’s eQMS is designed to accelerate safe innovation across the life sciences – with ready-to-use process coverage and best practices at your fingertips.  
“Dot Compliance has resulted in improved efficiency, giving us greater control, and has enabled us to make data-driven decisions.”
Carolyn Keeley
QA Specialist

The ready-to-deploy QMS software that delivers speed and smarts

Used by life sciences organizations around the world, Dot Compliance empowers teams to manage quality with confidence, maintain continuous compliance, and keep every process inspection ready.

The eQMS that keeps you one step ahead 

Dot Compliance is the industry’s first AI-powered eQMS, built to get you up and running fast – and to give you the insights to drive quality efficiently.

Why Dot Compliance?

Dot Compliance is leading the use of safe, effective AI to help accelerate innovation. We’re enabling life sciences organizations to build a culture of quality with advanced AI and get record time to value with our Salesforce-native platform that delivers speed, security and scale.

Get to know us better

Curious what we’ve been up to? Learn more.

FAQs

Do I need Salesforce to use Dot Compliance?

No. Dot Compliance runs on the Salesforce platform, but you don’t need a separate Salesforce license. Everything you need is included.

Is Dot Compliance validated?

Yes. All of our solutions come with full validation packages and meet global regulatory standards, including 21 CFR Part 11 and EU Annex 11.

Can I start small and scale later?

Absolutely. Our modular platform lets you start with what you need today and add more over time as your organization grows.

What support is available after go-live?

Absolutely. Our modular platform lets you start with what you need today and add more over time as your organization grows.

How does Dot Compliance support life sciences companies?

Dot Compliance provides a comprehensive eQMS tailored to life sciences. It covers everything from document control and CAPA management to training and regulatory compliance and much more.

How does Dot Compliance ensure fast implementation?

Dot Compliance offers pre-configured, ready-to-deploy solutions that allow for rapid deployment, enabling life sciences companies to get up and running quickly without extensive customization.

Can Dot Compliance integrate with existing systems?

Yes, Dot Compliance integrates easily with ERP systems and other critical tools through its native Salesforce platform, providing seamless connectivity.

Global compliance, baked in

Quality & Compliance Standards

Quality & Compliance Standards

  • ISO/IEC 42001 (AI Management Systems)
  • ISO 9001 (Quality Management Systems)
  • 
ISO/IEC 27001 (Information Security Management Systems)
  • GAMP 5 (Good Automated Manufacturing Practice for GxP Systems)
  • ISO/IEC 27017 (Cloud Security)
Medical Device

Medical Device

  • 21 CFR Part 820
  • ISO 13485
  • ISO 14971
Pharma & Biotech

Pharma & Biotech

  • 21 CFR Part 210
  • 
21 CFR Part 211
  • 
cGMP, cGDP, GCP

DOT IN THE NEWS

See what Dot Compliance has been up to—from our latest press releases, to upcoming events, thought leadership and more.