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Dot Compliance QMS
What it is
Dot Compliance QMS is an electronic quality management system for pharmaceutical, biotechnology, and medical device organizations. Its workflows cover document and training management, complaints, changes, CAPA, risk, quality events, supplier quality, equipment, regulatory work, and audits. The company says the system is built natively on Salesforce and provides a pre-validated solution with validation documentation. Salesforce also enables connections to customers’ existing data sources and processes. Electronic signature controls include multi-factor authentication, signature meaning, and a permanent time-stamped audit trail. The QMS supports requirements including 21 CFR Part 11, EU Annex 11, ISO 9001, ISO 13485, and ISO 14971. Its AI assistant, Dottie, is described as trained on quality management workflows. Access is listed for Android, iOS, and web; the Help Center includes a Salesforce for Mobile guide alongside manuals, tutorials, webinar materials, and tips. Pricing is available on request, with no free plan. Dot Compliance says it has supported life sciences companies since 2015 and has more than 500 customers across 30 countries.
For and against
For
- Covers document, CAPA, risk, complaint, and audit workflows.
- Includes multi-factor electronic signature controls and audit trails.
- Supports listed life sciences standards and regulations.
- Offers Android, iOS, and web access.
- Dottie is trained on quality management workflows.
Against
- No free plan is listed.
- Pricing is available on request.
- Requires buyers to request pricing.
The verdict
Dot Compliance QMS brings a broad set of life sciences quality workflows, signature controls, and stated regulatory support into one Salesforce-based system. Buyers should account for its paid-only model and request pricing directly.
Who it suits
It suits pharmaceutical, biotechnology, and medical device organizations managing quality processes and compliance records. Teams looking for mobile access and support resources can also consider its listed platforms and Help Center materials.
Plans and prices
Dot Compliance QMS
Pricing available on request · Demo offered
Read 8 Oct 2026 · dotcompliance.com
On the record
- AI assistant
- The company describes Dottie as an AI assistant trained on quality management workflows.dotcompliance.com · read 8 Oct 2026
- Company scale
- Dot Compliance says it has more than 500 customers across 30 countries.dotcompliance.com · read 8 Oct 2026
- Core workflows
- The QMS includes document, training, complaint, change, CAPA, risk, quality event, supplier quality, equipment, regulatory, and audit management.dotcompliance.com · read 8 Oct 2026
- Deployment
- Dot Compliance says its QMS is built natively on Salesforce and provides a pre-validated solution with validation documentation for customers.dotcompliance.com · read 8 Oct 2026
- Electronic signatures
- The company says its electronic signature controls include multi-factor authentication, signature meaning, and a permanent time-stamped audit trail.dotcompliance.com · read 8 Oct 2026
- Integrations
- The Salesforce platform enables integration with customers’ existing data sources and processes.dotcompliance.com · read 8 Oct 2026
- Mobile access
- The Help Center lists a Salesforce for Mobile user quick guide.dotcompliance.com · read 8 Oct 2026
- Purpose
- Dot Compliance provides an electronic quality management system for life sciences organizations.dotcompliance.com · read 8 Oct 2026
- Regulatory support
- Dot Compliance says its QMS supports life sciences requirements including 21 CFR Part 11, EU Annex 11, ISO 9001, ISO 13485, and ISO 14971.dotcompliance.com · read 8 Oct 2026
- Support resources
- The Help Center provides user manuals, video tutorials, webinar materials, and tips and tricks.dotcompliance.com · read 8 Oct 2026
- Target users
- The company describes its solutions as designed for pharmaceutical, biotechnology, and medical device organizations.dotcompliance.com · read 8 Oct 2026