Making Quality and Compliance a Strategic Advantage Across all
Life Science Industries

Medicinal Cannabis

Gain visibility over your operations and the entire manufacturing process. From document and training management to CAPA, audit, and supplier management – choose any or all modules from our core QMS offering to improve processes and maintain compliance with the ever growing cannabis regulatory landscape.

Help ensure compliance with the following regulations:

  • HIPPA
  • ISO 9001
  • FDA Software Validation 11
  • Gamp 5 Validation

Hospital Laboratories

Laboratory quality within a healthcare delivery network requires visibility and accuracy to properly manage, track, and report on laboratory operations and services. Dot Compliance helps organizations with all quality and compliance aspects of the research, documentation, and evaluations to ensure all processes meet Good Clinical, Laboratory, and Manufacturing Practices (GxP).

Help ensure compliance with the following regulations:

  • FDA 21 CFR Part 11
  • Gamp 5 Validation
  • HIPPA
  • ISO 9001
  • FdA Software Validation

Digital Health

Traditional and legacy QMS can’t handle the complexity of today’s digital health challenges that range from mobile health, wearables, health information technology, telehealth and telemedicine. Dot Compliance helps manage processes and data being pulled from different platforms, connected IoT sensors, and software through big data management, IoT integration, and proactive management of quality events based on AI and Machine Learning capabilities.

Help ensure compliance with the following regulations:

  • GxP
  • FDA 21 CFR Part 11
  • Gamp 5 Validation
  • ISO 9001
  • FDA Software Validation

Life Science Service Providers

Dot Compliance’s ready to use QMS solutions are trusted by global service providers who offer regulatory, compliance, quality, and pharmacovigilance services to pharmaceutical, biotech, and medical device manufacturers.

Help ensure compliance with the following regulations:

  • GxP
  • FDA Software Validation
  • Gamp 5 Validation
  • ISO 9001
  • FDA 21 CFR Part 11

You are in good company.

Best in class life science companies around the world trust Dot with their QMS.

With Dot Compliance, we were able to create a single source for all controlled documentation.
We also were able to seamlessly connect our complaint handling solution to deviations and batch records.

Experience ready to use QMS

Find the Dot Compliance Solution for you

Addressing any eQMS need, for any size company with unmatched breadth and depth process coverage

QMS Xpress Symbol

QMS Xpress

Set your eQMS foundation with a comprehensive set of ready to use core quality processes

Xpand

Compliance Xpand

Build upon core eQMS, expanding into other manufacturing quality and compliance specialty areas

Xact

Enterprise Xact

Tailored eQMS, with customized and configured quality and compliance processes based on your unique requirements