Dot Compliance 2026: Benefits, Features & Pricing
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- Overview
- Pricing and Plans
- Features
- Integrations
- User Reviews
Overview
Pricing
Pricing available upon request
About Dot Compliance
Dot Compliance is an electronic quality management system (eQMS) designed for the life sciences industry. It supports pharmaceutical, biotechnology, and medical device organizations in managing quality processes and meeting regulatory requirements. The system includes features such as document management, change management, audit management, training management, CAPA management, complaint management, quality event management, risk management, and supplier quality management.
An AI assistant, "Dottie," is integrated into the platform to assist with quality and compliance workflows. Dot Compliance offers solutions tailored to organizational needs, ranging from core processes to advanced analytics. The system is pre-built and pre-validated with industry workflows to support faster implementation. It complies with 21 CFR Part 11, EU Annex 11, and ISO standards such as 9001, 13485, 14971, and 27001. The platform is designed to help life sciences companies manage regulatory compliance and make informed decisions.
Dot Compliance Screenshots

Dot Compliance Pricing and Plans
Pricing available upon request
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Dot Compliance Features
- Popular features found in Document ManagementAccess Controls/PermissionsArchiving & RetentionCollaboration ToolsCompliance TrackingDocument ClassificationDocument EditingDocument GenerationElectronic SignatureFile ConversionFile SharingThird-Party IntegrationsVersion Control
- More features of Dot ComplianceActivity DashboardActivity TrackingAlerts/EscalationAlerts/NotificationsAnnotationsAPIApproval Process ControlAssessment ManagementAudit ManagementAudit TrailBills of MaterialCalendar ManagementCalibration ManagementCertification TrackingChange ManagementCommenting/NotesCommunications ManagementComplaint ManagementCompliance ManagementContent ManagementCorrective and Preventive Actions (CAPA)Cost TrackingCustomizable BrandingCustomizable FieldsCustomizable ReportsCustomizable TemplatesData Import/ExportData SecurityData VisualizationDefect TrackingDesign ManagementDigital SignatureDocument AutomationDocument CaptureDocument Coding & ControlDocument Lifecycle ManagementDocument ManagementDocument ReviewDocument StorageDocument TemplatesDrag & DropEmail AlertsEmail ManagementEquipment ManagementFDA ComplianceFile ManagementFile RecoveryFor Legal ProfessionalsFor Medical PurposesForms ManagementFull Text SearchHIPAA CompliantIdeationIncident ManagementIndexingInspection ManagementISO ComplianceISO Standards ManagementItem ManagementLifecycle ManagementMaintenance ManagementMetadata ExtractionMilestone TrackingMobile AccessMonitoringMultiple Format SupportNonconformance TrackingOffline AccessPolicy ManagementPortfolio ManagementPrioritizationProduct Data ManagementProduction ManagementProgress TrackingProject ManagementQuality ControlQuality ManagementReal-Time DataReal-Time NotificationsReal-Time ReportingReal-Time UpdatesRegulatory ReportingRemindersReporting & StatisticsRequirements ManagementRevision HistoryRisk AssessmentRisk ManagementRole-Based PermissionsRoot Cause AnalysisRules-Based WorkflowSearch/FilterSecure Data StorageSSL SecurityStatistical Process ControlStatus TrackingSupplier ManagementSupplier Quality ControlSurveys & FeedbackTaggingTask ManagementTraining ManagementTrend AnalysisWorkflow Management
Dot Compliance Integrations
See all 14 integrations
Dot Compliance User Reviews
Overall Rating
4.4
Ratings Breakdown
5
51%
4
40%
3
6%
2
3%
1
0%
Secondary Ratings
Ease of Use
4.2
Value for money
4.2
Customer support
4.3
Functionality
4.3

Doron C.
Verified reviewer
Biotechnology
51-200 employees
Used daily for more than 2 years
Review sourceReviewed August 2022
DOT compliance review
4
OK experience, depends on amount of customization done at setp.
Ratings Breakdown
Vendor Response
Hi Doron, Thanks for your feedback. We reecently expanded our Support team to both Israel and the USA, thus improving the availability of our service as well as the response time. Our Lightning versions in past 3 years include new capabilities and new features, as well as UI improvements to make the use more accessible for the user In addtion the upgrade process have been reduced significantly and we urge customers to upgrade to the latest version. Adam Yona, VP of Product
Replied December 2022
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Barry J.
Verified reviewer
Biotechnology
11-50 employees
Used weekly for less than 12 months
Reviewed December 2025
Operations
5
Overall I am definitely pleased with the system. It provides a highly secure, reliable, and scalable platform that is natively compliant, avoiding complex integrations and leveraging an interface many users already know.
Ratings Breakdown
Reasons for switching to Dot Compliance
Cost and build out were expensive to maintain
Vendor Response
Thank you so much for the thoughtful review. We're glad to hear Dot Compliance is helping simplify your regulatory work and adding value for your team. Brenda Percy - Senior Marketing Manager, North America
Replied December 2025
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Leanne W.
Verified reviewer
Pharmaceuticals
501-1000 employees
Used daily for less than 6 months
Reviewed October 2025
First time user of Dot Compliance
3
My overall experience has been great. I have found the staff very friendly, helpful and quick in their response time during the implementation of this system.
Ratings Breakdown
Reasons for switching to Dot Compliance
The system was too limiting for the price
Vendor Response
Thank you for the review! We appreciate you taking the time to share your feedback with us, as it plays a key role in ensuring our continual improvement. Brenda Percy, Senior Marketing Manager - North America
Replied October 2025
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Satyaprasad C.
Verified reviewer
Pharmaceuticals
51-200 employees
Used daily for less than 6 months
Reviewed November 2025
DOT Delightful FOR COMPLIANCE
5
Overall, it was a very good experience. I observed the window during that time, and I am aware of which season it is, as well as the work that needs to be completed. I find the space to be a good experience, particularly with PDF generation and audit trails. The window displays all the mistakes they find, allowing them to correct them. I am also very impressed with the Dot compliance team for their promotions and support at various work levels.
Ratings Breakdown
Vendor Response
Thank you for the feedback! We’re glad the platform has been helpful, and we appreciate the input as part of our ongoing commitment to continuous improvement. Brenda Percy, Senior Marketing Manager - North America
Replied December 2025
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Melanie L.
Verified reviewer
Pharmaceuticals
51-200 employees
Used daily for less than 2 years
Reviewed September 2025
Dependable eQMS that offers a good value for your money.
5
Overall, we are satisfied with Dot. The internal staff transitioned to the eQMS quickly and the modules were easy to use.
Ratings Breakdown
Vendor Response
Thank you for sharing your experience and for highlighting the smooth transition and ease of use. We appreciate your valuable feedback regarding project management continuity during implementation. Happy to hear your team has adapted well and is seeing value from the system! Brenda Percy, Senior Marketing Manager - North America
Replied October 2025
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Roger B.
Verified reviewer
Medical Devices
51-200 employees
Used daily for less than 2 years
Reviewed October 2025
Qualification united !
5
Generally pleasant. It is a great tool for our company in terms of managing several modules, especially the ones that relates to control of documentations.
Ratings Breakdown
Vendor Response
Thank you for sharing your feedback! We’re glad to hear that Dot Compliance is helping your team manage quality and documentation effectively. We appreciate your continued trust and partnership. Brenda Percy, Senior Marketing Manager - North America
Replied October 2025
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MAHESH S.
Verified reviewer
Pharmaceuticals
51-200 employees
Used daily for less than 6 months
Reviewed November 2025
Reliable Compliance Management with Room for UI Improvement
4
Overall, it’s a reliable and comprehensive compliance solution. It has improved our documentation and audit processes significantly.
Ratings Breakdown
Vendor Response
Thank you for taking the time to share your review and for being a valued client. We appreciate your feedback! Brenda Percy, Senior Marketing Manager - North America
Replied November 2025
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Alexis L.
Verified reviewer
Biotechnology
11-50 employees
Used daily for less than 2 years
Reviewed October 2025
Best Quality Management tool
5
Dot Compliance has simplified the collaboration process and help us speed up our Quality Management Process.
Ratings Breakdown
Vendor Response
Thank you for sharing your experience and for highlighting how Dot Compliance has helped streamline collaboration and quality management for your team. We’re glad to hear it’s driving efficiency and supporting your goals. It’s great feedback that you’re continuing to discover new ways to use the platform! Brenda Percy, Senior Marketing Manager - North America
Replied October 2025
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Daniel P.
Verified reviewer
Biotechnology
1001-5000 employees
Used daily for more than 2 years
Reviewed November 2025
Dot Compliance: User Friendly Documentation Storage
5
Overall, Dot Compliance has been a useful tool to store, manage, and edit documentation. It is a clear, linear system that is user friendly and invites collaboration.
Ratings Breakdown
Vendor Response
Thank you for sharing your feedback! We’re glad to hear Dot Compliance has been a helpful tool for managing and collaborating on documentation. We appreciate you taking the time to share your experience with us. Brenda Percy, Senior Marketing Manager - North America
Replied November 2025
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Lindsey H.
Verified reviewer
Research
51-200 employees
Used daily for more than 2 years
Reviewed August 2025
Attractive QMS and Clinical solution to hold records from clinical studies and more
4
I would recommend this software as a budget efficient QMS and clinical record software that can save everything, with 21 CFR Part 11 compliant features.
Ratings Breakdown
Vendor Response
Thank you for your thoughtful review and for being such a valued partner. Feedback like yours directly guides our product's evolution, and we are grateful for it. Brenda Percy, Senior Marketing Manager - North America
Replied August 2025
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