About Dot Compliance

Dot Compliance offers the industry's first ready to use Quality Management Solution powered by the Salesforce.com platform. The Dot Compliance Suite includes an extensive set of off-the-shelf ready eQMS and compliance pre-configured best practice processes, enabling customers to deploy quickly and cost effectively.
Dot Compliance ready to use solutions include full project validation services and product validation packages. Our solutions are trusted by many life sciences companies worldwide and by thousands of users. We are fully compliant with 21 CFR part 11, EU-Annex 11 and support ISO 9001, 13485, 14971 and 27001.

Dot Compliance is a platform that helps life science companies manage pre or post-market quality processes including CAPA, change control, training, document control, batch records, and more. Features include workflows, compliance dashboards, big data integration, AI, audit management, and more.

With Dot Compliance, users have access to pre-engineered and pre-validated quality management processes enabling cross-organization visibility, insights, and trend tracking for data-driven decision making. The platform uses machine learning, big data technology, and AI (artificial intelligence) to provide users with predictions and recommendations for quality management improvements.

The Dot Compliance platform ensures companies are audit-ready with features such as document management, training management, corrective and preventive action (CAPA), risk management, and supplier quality management. Additionally, cross-organization processes such as batch and design control, equipment and maintenance management, clinical trials, and enterprise application integration can be managed in the platform, as well as regulatory affairs and audit management.

Ready to use solutions include:

▶ Document Management – Capture, track and store all your documents in one place. Our capabilities include Part 11 Compliant e-signatures, approval workflow, revisions control and more. It easily integrates with other QMS business processes providing a closed loop system.

▶ Training Management - Manage end-to-end employee training from record management, course distribution and completion, and escalation.

▶ Complaint Management – Ready to use compliant handling ensures regulatory compliance, enhances product development, mitigates risk, and finds opportunities for growth and innovation by meeting specific customer requirements.

▶ Change Management – Change Control through QMS Xpress offers a standardized process for workflow flexibility, allowing a life sciences manufacturer to manage all types of changes from one centralized platform.

▶ CAPA - Dot Compliance automates CAPA processes to safeguard your organization from regulatory risk, and include integration with other core quality processes such as audit, training, document management, change control, etc.

▶ Risk Management – A proactive and risk based approach to quality management systems minimizes the chances for undesired effects as well as continual improvement by predicting potential problems. It also lowers the risk of manufacturing problems that may result in shorter and fewer FDA and EMA inspections.

▶ Deviations/Non-conformance Management – Managing deviations and other quality events is required by GMP. Dot Compliance cloud-based, fully validated QMS provides organizations with the ability to manage deviations so they are identified and recorded. This includes Incidents that could affect the quality or the reliability of records or tests to be investigated and resolved.

▶ Supplier Quality Management - Manage, track, and collaborate with suppliers, contract manufacturers, and distribution chain partners across the entire supply chain. Consolidate quality management silos of suppliers, contracted manufacturing organizations (CMO), internal production divisions, and distribution supply chain into one connected quality system.

Pricing starting from:

US$9.00/year

  • Free Version
  • Free Trial
  • Subscription

Key benefits of Dot Compliance

Forget about lengthy & costly QMS implementations.

Dot Compliance provides data migration expertise to overcome the challenges for a quick and cost-effective QMS implementation.

Processes included:
▶ Document Management
▶ Training Management
▶ Quality Event Management
▶ CAPA Management
▶ Change Management
▶ Complaint Management
▶ Audit Management
▶ Supplier Quality Management
▶ Risk Management
▶ Design Control
▶ Deviations/Non-conformances

✔ Seamless Install - Deploy quickly and get up and running within a matter of days with minimal set up required. Leveraging advanced data migration capabilities, Dot Compliance offers the industry's fastest QMS deployment.

✔ Cost Effective - Comprehensive ready to use QMS solutions 20-30% less expensive than other industry solutions. Eliminate the need for expensive consultants & services. Pre-configured and pre-validated with sample SOPs and KPIs.

✔ One-Stop-Shop - For life science manufacturers of all sizes, we offer a comprehensive set of ready-to-use solutions: QMS, Document Management, Supplier Quality, Audits, EBR, PLM, LIMS, RA, CTMS, Maintenance, and more.

Typical Customers

  • Freelancers
  • Small Businesses (2-50)
  • Mid-size Companies (51-500)
  • Large enterprises (500 and more)

Deployment

  • Cloud-based
  • On-premise

Markets

Andorra, Antigua and Barbuda, Anguilla, Albania, American Samoa , Austria, Australia, Aruba, Åland Islands, Bosnia and Herzegovina, Barbados, Belgium, Bulgaria, Bermuda, Brazil, Bahamas, Belarus, Belize, Canada, Switzerland, Cook Islands, China, Costa Rica, Cuba, Cyprus, Czechia, Germany, Denmark, Dominica, Dominican Republic, Estonia, Spain, Finland, Fiji, Micronesia, Faroe Islands, France, United Kingdom, Grenada, Georgia, Guernsey, Gibraltar, Greenland, Guadeloupe, Greece, Guatemala, Guam, Honduras, Croatia, Haiti, Hungary, Ireland, Israel, Isle of Man, Iceland, Italy, Jersey, Jamaica, Japan, Kiribati, Saint Kitts and Nevis, Cayman Islands, Saint Lucia, Liechtenstein, Lithuania, Luxembourg, Latvia, Monaco, Moldova, Montenegro, Saint Martin, Marshall Islands, North Macedonia, Northern Mariana Islands, Martinique, Montserrat, Malta, New Caledonia, Norfolk Island, Nicaragua, Netherlands, Norway, Nauru, New Zealand, Panama, French Polynesia, Papua New Guinea, Poland, Saint-Pierre-et-Miquelon, Puerto Rico, Portugal, Palau, Romania, Serbia, Russia, Solomon Islands, Sweden, Slovenia, Svalbard and Jan Mayen, Slovakia, San Marino, El Salvador, Turks and Caicos Islands, Tonga, Turkey, Trinidad and Tobago, Tuvalu, Ukraine, United States, Vatican City, Saint Vincent and the Grenadines, British Virgin Islands, U.S. Virgin Islands, Vietnam, Vanuatu, Wallis and Futuna, Samoa

Supported Languages

English, European Portuguese, French, German, Hebrew , Portuguese, Russian, Spanish

Pricing starting from:

US$9.00/year

  • Free Version
  • Free Trial
  • Subscription

Images

Dot Compliance Software - Improve your quality control and compliance with the industry's top solution for quality management. Save time and money while delivering products to market quickly and efficiently.
Dot Compliance Software - Dot Compliance provides the industry’s first off the shelf QMS solution – ready to deploy from day one, with little to no setup required, while also incorporating industry best practices and standards that address the latest regulatory requirements.
Dot Compliance Software - We help companies navigate the ever changing landscape of implementing electronic quality management systems. We are a team of top experts in enterprise software technology, quality and compliance regulation, and process engineering.
Dot Compliance Software - Based on pre-configured industry best practices, our QMS Xpress enables life science organizations to quickly digitize their quality and compliance processes.
Dot Compliance Software - Our platform is powered by Salesforce and coupled with a fully executed validation package, Dot Compliance’s QMS Xpress helps set a solid foundation for scalable growth.
View 6 more
Dot Compliance video
Dot Compliance Software - Improve your quality control and compliance with the industry's top solution for quality management. Save time and money while delivering products to market quickly and efficiently.
Dot Compliance Software - Dot Compliance provides the industry’s first off the shelf QMS solution – ready to deploy from day one, with little to no setup required, while also incorporating industry best practices and standards that address the latest regulatory requirements.
Dot Compliance Software - We help companies navigate the ever changing landscape of implementing electronic quality management systems. We are a team of top experts in enterprise software technology, quality and compliance regulation, and process engineering.
Dot Compliance Software - Based on pre-configured industry best practices, our QMS Xpress enables life science organizations to quickly digitize their quality and compliance processes.
Dot Compliance Software - Our platform is powered by Salesforce and coupled with a fully executed validation package, Dot Compliance’s QMS Xpress helps set a solid foundation for scalable growth.

Features

Total features of Dot Compliance: 93

  • API
  • Access Controls/Permissions
  • Action Management
  • Activity Dashboard
  • Activity Tracking
  • Alerts / Escalation
  • Alerts/Notifications
  • Approval Process Control
  • Archiving & Retention
  • Audit Management
  • Audit Trail
  • Change Management Software
  • Collaboration Tools
  • Commenting/Notes
  • Communications Management
  • Complaint Management Software
  • Compliance Management
  • Compliance Tracking
  • Configurable Workflow
  • Content Management System (CMS) Software
  • Controls Audit
  • Corrective and Preventive Actions (CAPA)
  • Customizable Branding
  • Customizable Fields
  • Customizable Forms
  • Customizable Reports
  • Customizable Templates
  • Data Import/Export
  • Defect Tracking
  • Design Management
  • Digital Signature Software
  • Document Automation
  • Document Capture
  • Document Classification
  • Document Coding & Control
  • Document Generation Software
  • Document Management Software
  • Document Review
  • Document Storage
  • Document Templates
  • Drag & Drop
  • Electronic Signature
  • Email Alerts
  • Email Management Software
  • Equipment Management
  • FDA Compliance
  • File Conversion
  • File Management
  • File Recovery
  • File Sharing Software
  • File Transfer
  • Forms Management
  • Full Text Search
  • HIPAA Compliant
  • ISO Compliance
  • ISO Standards Management
  • Incident Management Software
  • Inspection Management
  • Issue Management
  • Maintenance Management Software
  • Monitoring
  • Nonconformance Tracking
  • Offline Access
  • Process/Workflow Automation
  • Product Data Management Software
  • Progress Tracking
  • Project Management Software
  • Quality Assurance
  • Quality Control
  • Real Time Analytics
  • Real Time Data
  • Real Time Monitoring
  • Real Time Reporting
  • Real-time Updates
  • Reminders
  • Reporting & Statistics
  • Requirements Management Software
  • Risk Assessment
  • Risk Management Software
  • Role-Based Permissions
  • Root Cause Analysis
  • Search/Filter
  • Secure Data Storage
  • Supplier Management
  • Supplier Quality Control
  • Surveys & Feedback
  • Task Management Software
  • Template Management
  • Third Party Integrations
  • Training Management
  • Training Record Management
  • Version Control
  • Workflow Management Software

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Reviews

Overall rating

4.4 /5
(18)
Value for Money
3.9/5
Features
4/5
Ease of Use
3.9/5
Customer Support Software
4.1/5

Already have Dot Compliance?

Software buyers need your help! Product reviews help the rest of us make great decisions.

Write a Review!
Showing 5 reviews of 18
Bella
Overall rating
  • Industry: Pharmaceuticals
  • Company size: 201-500 Employees
  • Used Daily for 6-12 months
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 10.0 /10

My Review for Dot Compliance

Reviewed on 2020-03-04

Pros

The product is user friendly. The flows in the system are the best practices that are used in the pharmaceutical industry (21 CFR Part 11, Annex 11, GAMP 5).
Almost no adjustments (customizations) are needed.
The validation package is very thorough and comprehensive.
The software is stable almost without faults

Cons

The main problem for us is the use of Hebrew. Especially when using Hebrew and English together.

Arnan
Overall rating
  • Industry: Pharmaceuticals
  • Company size: Self Employed
  • Used Daily for 6-12 months
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 10.0 /10

A very versatile QMS which was built by knowledgeable people

Reviewed on 2020-03-05

Once the system is on, using DOT compliance system reduce efforts of all activities. All the...

Once the system is on, using DOT compliance system reduce efforts of all activities. All the information can be found and manual or written and printed processes are no longer needed which saves time and efforts. The system takes care to follow after processes so things are not left behind or forgotten.

Pros

The system is user friendly even when the processes are complicated. There is a full integration between all modules so it is easy to get the connection between different activities. Connection can be by equipment, product, batch number and such. It is evident that the system was built by people who have deep understanding in quality processes of pharmaceutical companies.

Cons

There are some limitations due to the fact that the system is built on "Salesforce" platform but in most cases DOT can find a solution.

Alternatives Considered

Agile PLM

Reasons for Switching to Dot Compliance

Ease of use, quality processes understanding, local support, knowing the people behind the system
Lilya
Overall rating
  • Industry: Pharmaceuticals
  • Company size: 11-50 Employees
  • Used Daily for 1+ year
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 4.0 /10

expensive, not user friendly for most users, support not immediate available,

Reviewed on 2022-07-28

there are other E-AMS sytems less expensive with customer servise available at immediate

there are other E-AMS sytems less expensive with customer servise available at immediate

Pros

hermetic managment a lot of modules for E-QMS

Cons

PV and RA does not support efficient managment of documents
life cycle too long

Expensive

not user friendly for most users
no differention to "superlight" users (for training of staff)

Response from Dot Compliance

"Dear Lilya,
We are very sorry to hear we didn't meet your expectations.
We continuously work on product improvements such as regulatory submissions. Our support team is expanding to help respond quicker to customer inquiries. Regularly scheudled webinars & free online trainings are available to all users.

Best regards,
Adam Rona, VP of Product"

Corinne
Overall rating
  • Industry: Biotechnology
  • Company size: 11-50 Employees
  • Used Daily for 6-12 months
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 5.0 /10

Promising sometimes disappointing

Reviewed on 2020-03-09

frustrating

frustrating

Pros

Good documentation management system
allows an easy retrieving of document and features

Cons

1 the version we got is "one size fits no one" the system was obviously developed to be used by a large panel of users: medical device, drugs, biotechnology. In the end, some of the features are ill-fitted
2 no confidentiality level: once a document is approved it can be viewed and printed by anyone. Masterbatch records should be only available to QA but not possible. Some document s should be restricted: labels ..not possible
3 approval of investigation, deviations CC intermediate steps .... are possible without QA review
4 risk assessments are approved only by QA - do not require additional review by professional personnel
5 professional support is not enough GMP oriented
6 the writing interphase is not comfortable at all
7 why do we have to open an investigation for each deviation- everything is written in the deviation screen any way
8 why do we have to open an investigation for QA events-usually CAPA are opened directly
THe investigation feature is shallow and does not allow the review of essential criteria such as operator, materials, equipment training and qualification
advanced feature are too expensive or require one on one training
some of the feature are not described in the manual

Santino
Overall rating
  • Industry: Education Management
  • Company size: 501-1,000 Employees
  • Used Weekly for 6-12 months
  • Review Source

Overall rating

  • Ease of Use
  • Likelihood to recommend 8.0 /10

Dot Compliance Review

Reviewed on 2022-06-01

Pros

Very stable and user friendly software that has helped to make our critical record keeping efficient.

Dot Compliance has an excellent document management system and I expect that it will grow to become even better.

Very good tutorial resources are very helpful during integration.

Very good technical support from the team when any issues arise.

Cons

There are some restrictions due to the platform is built on Salesforce.

Response from Dot Compliance

Hey there Santino!
Thank you very much for your review, Residing on Salesforce platform does require us to follow salesforce guidelines but it also enables us to deliver to our customers, a fast, cost-effective, and ready-to-use solution with great development flexibility and many infrastructures and security benefits that come with SAAS platform.

Best,
Adam Rona, VP Product

Showing 5 reviews of 18 Read all reviews

Dot Compliance FAQs

Below are some frequently asked questions for Dot Compliance.

Dot Compliance offers the following pricing plans:

  • Starting from: US$9.00/year
  • Pricing model: Subscription
  • Free Trial: Available

Contact Dot Compliance for pricing information.

Dot Compliance has the following typical customers:

11-50, 51-200, 201-500, 501-1,000

Dot Compliance supports the following languages:

English, European Portuguese, French, German, Hebrew, Portuguese, Russian, Spanish

Dot Compliance supports the following devices:

Android (Mobile), iPhone (Mobile), iPad (Mobile)

Dot Compliance integrates with the following applications:

Salesforce Sales Cloud

Dot Compliance offers the following support options:

Email/Help Desk, FAQs/Forum, Knowledge Base Software, Phone Support, Chat

Related categories

See all software categories found for Dot Compliance.