--- title: Healthcare QMS Software | Dot Compliance description: Ensure compliance and streamline quality with the AI-powered QMS software built for healthcare. Get a demo of Dot Compliance today. --- [Skip to content](https://info.dotcompliance.com/qms-healthcare-v6#main-content) [![](https://info.dotcompliance.com/hubfs/raw_assets/public/DotCompliance/images/header_logo.svg)](https://www.dotcompliance.com/) Open main navigation Close main navigation - [Get a demo](https://info.dotcompliance.com/qms-healthcare-v6#contact) [Get a demo](https://info.dotcompliance.com/qms-healthcare-v6#contact) # Ensure compliance with the AI-Powered healthcare QMS **Get a demo of the leading QMS software.** - Most cost-effective & agile - Scalable with out-of-the-box solutions - Adaptable compliance workflows ![milestone](https://info.dotcompliance.com/hs-fs/hubfs/milestone.png?width=88&height=103&name=milestone.png)![captera-1](https://info.dotcompliance.com/hs-fs/hubfs/captera-1.png?width=143&height=47&name=captera-1.png)![appex](https://info.dotcompliance.com/hs-fs/hubfs/appex.png?width=127&height=48&name=appex.png) ### Get a Demo - ![biopharma](https://info.dotcompliance.com/hubfs/biopharma.svg) - ![stereotix](https://info.dotcompliance.com/hubfs/stereotix.svg) - ![gamida](https://info.dotcompliance.com/hubfs/gamida.svg) - ![change](https://info.dotcompliance.com/hubfs/change.svg) - ![famar](https://info.dotcompliance.com/hubfs/famar.svg) - ![caris](https://info.dotcompliance.com/hubfs/caris.svg) - ![vitalant](https://info.dotcompliance.com/hubfs/vitalant.svg) - ![insightec](https://info.dotcompliance.com/hubfs/insightec.svg) - ![propharma](https://info.dotcompliance.com/hubfs/propharma.svg) - ![biopharma](https://info.dotcompliance.com/hubfs/biopharma.svg) - ![stereotix](https://info.dotcompliance.com/hubfs/stereotix.svg) - ![gamida](https://info.dotcompliance.com/hubfs/gamida.svg) - ![change](https://info.dotcompliance.com/hubfs/change.svg) - ![famar](https://info.dotcompliance.com/hubfs/famar.svg) - ![caris](https://info.dotcompliance.com/hubfs/caris.svg) - ![vitalant](https://info.dotcompliance.com/hubfs/vitalant.svg) - ![insightec](https://info.dotcompliance.com/hubfs/insightec.svg) - ![propharma](https://info.dotcompliance.com/hubfs/propharma.svg) - ![biopharma](https://info.dotcompliance.com/hubfs/biopharma.svg) - ![stereotix](https://info.dotcompliance.com/hubfs/stereotix.svg) - ![gamida](https://info.dotcompliance.com/hubfs/gamida.svg) - ![change](https://info.dotcompliance.com/hubfs/change.svg) - ![famar](https://info.dotcompliance.com/hubfs/famar.svg) - ![caris](https://info.dotcompliance.com/hubfs/caris.svg) - ![vitalant](https://info.dotcompliance.com/hubfs/vitalant.svg) - ![insightec](https://info.dotcompliance.com/hubfs/insightec.svg) - ![propharma](https://info.dotcompliance.com/hubfs/propharma.svg) - ![biopharma](https://info.dotcompliance.com/hubfs/biopharma.svg) - ![stereotix](https://info.dotcompliance.com/hubfs/stereotix.svg) - ![gamida](https://info.dotcompliance.com/hubfs/gamida.svg) - ![change](https://info.dotcompliance.com/hubfs/change.svg) - ![famar](https://info.dotcompliance.com/hubfs/famar.svg) - ![caris](https://info.dotcompliance.com/hubfs/caris.svg) - ![vitalant](https://info.dotcompliance.com/hubfs/vitalant.svg) - ![insightec](https://info.dotcompliance.com/hubfs/insightec.svg) - ![propharma](https://info.dotcompliance.com/hubfs/propharma.svg) ## Why Leading Healthcare Organizations Choose Our QMS Software ![AI-powered. Ready-to-deploy.](https://info.dotcompliance.com/hs-fs/hubfs/raw_assets/public/DotCompliance/images/services/ai-powered.png?width=468&height=400&name=ai-powered.png) ## AI-powered. Ready-to-deploy. Move faster with the industry's first pre-validated, ready-to-deploy QMS, purpose-built for life sciences. Accelerate your deployment, leverage built-in best practices, and harness AI-powered quality management from day one. ![Native to Salesforce](https://info.dotcompliance.com/hubfs/raw_assets/public/DotCompliance/images/services/nativetosf.svg) ## Native to Salesforce Dot Compliance is 100% Salesforce-native, which means you get a consistent user experience,  easy integration with existing systems, and scalability and security right out of the box.  ![Trusted by life sciences](https://info.dotcompliance.com/hs-fs/hubfs/raw_assets/public/DotCompliance/images/services/trustedby.png?width=490&height=400&name=trustedby.png) ## Trusted by life sciences Purpose-built for pharma, biotech, and medical device companies, Dot Compliance streamlines quality processes, simplifies regulatory compliance, and accelerates time to market. ## Chosen by teams like yours From fast-growing startups to global leaders, life sciences companies choose Dot Compliance to modernize their quality systems. ![Our story](https://info.dotcompliance.com/hubfs/raw_assets/public/DotCompliance/images/chosen.png "Our story") > “Dot Compliance has resulted in improved efficiency, giving us greater control, and has enabled us to make data-driven decisions.” > > Carolyn Keeley, > QA Specialist at VLE ## FAQs 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? Our customer success and support teams are with you every step of the way. You'll also have access to knowledge resources, product updates, and more. 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. ## Global compliance, baked in ### Medical Device Built to help manufacturers meet global device regulations and quality system standards, including: - 21 CFR Part 820 - ISO 13485 - ISO 14971 ### Pharma & Biotech Designed to help pharmaceutical and biotech organizations meet global manufacturing and compliance standards, including: - 21 CFR Part 210 - 21 CFR Part 211 - cGMP, cGDP, GCP ### Quality & Compliance Standards Dot Compliance is certified to: - ISO/IEC 42001 (AI Management Systems) - ISO 9001 (Quality Management Systems) - ISO/IEC 27001 (Information Security Management Systems) - ISO/IEC 27017 (Cloud Security) ![Quality & Compliance Standards](https://info.dotcompliance.com/hubfs/raw_assets/public/DotCompliance/images/certs/medical.svg "Quality & Compliance Standards") ## The healthcare 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. - ![Document Management](https://info.dotcompliance.com/hubfs/raw_assets/public/DotCompliance/images/benefits/Document%20Management.svg) Document Management - ![Audit Management](https://info.dotcompliance.com/hubfs/raw_assets/public/DotCompliance/images/benefits/Audit%20Management.svg) Audit Management - ![Complaint Management](https://info.dotcompliance.com/hubfs/raw_assets/public/DotCompliance/images/benefits/Complaint%20Management.svg) Complaint Management - ![Equipment Management](https://info.dotcompliance.com/hubfs/raw_assets/public/DotCompliance/images/benefits/Equipment%20Management.svg) Equipment Management - ![Change Management](https://info.dotcompliance.com/hubfs/raw_assets/public/DotCompliance/images/benefits/Change%20Management.svg) Change Management - ![Training Management](https://info.dotcompliance.com/hubfs/raw_assets/public/DotCompliance/images/benefits/Training%20Management.svg) Training Management - ![Risk Management](https://info.dotcompliance.com/hubfs/raw_assets/public/DotCompliance/images/benefits/Risk%20Management.svg) Risk Management - ![Electronic Batch Management](https://info.dotcompliance.com/hubfs/raw_assets/public/DotCompliance/images/benefits/Electronic%20Batch%20Management.svg) Electronic Batch Management - ![Quality Event Managementl](https://info.dotcompliance.com/hubfs/raw_assets/public/DotCompliance/images/benefits/Quality%20Event%20Management.svg) Quality Event Management - ![CAPA Management](https://info.dotcompliance.com/hubfs/raw_assets/public/DotCompliance/images/benefits/CAPA%20Management.svg) CAPA Management - ![Supplier Quality Management](https://info.dotcompliance.com/hubfs/raw_assets/public/DotCompliance/images/benefits/Supplier%20Quality%20Management.svg) Supplier Quality Management ## Get a Demo of the AI-Powered QMS Software See why leading pharma, biotech, and medical device companies rely on our AI-powered QMS to stay compliant. Get a demo ![Dot Compliance Logo](https://info.dotcompliance.com/hs-fs/hubfs/Dot%20Compliance%20white%20one%20line-2.png?width=190&height=46&name=Dot%20Compliance%20white%20one%20line-2.png) Contact Us:  +1-628-239-0188   |   Hello@dotcompliance.com [Privacy Policy](https://www.dotcompliance.com/privacy-policy/)    |    [Terms & Conditions](https://www.dotcompliance.com/terms-conditions/) © 2026 Dot Compliance Ltd. All rights reserved. [![linkedin icon](https://info.dotcompliance.com/hs-fs/hubfs/linkedin%20icon.png?width=38&height=38&name=linkedin%20icon.png)](https://www.linkedin.com/company/10474061) [![twitter icon](https://info.dotcompliance.com/hs-fs/hubfs/twitter%20icon.png?width=38&height=38&name=twitter%20icon.png)](https://twitter.com/Dotcompliance_) [![youtube icon](https://info.dotcompliance.com/hs-fs/hubfs/youtube%20icon.png?width=38&height=38&name=youtube%20icon.png)](https://www.youtube.com/channel/UCnwtZJkKfoUfauUGPvDGcjA)