Quality and Compliance Solutions for the Pharmaceutical and Biotech industries

Pharmaceutical

THE CHALLENGE

QMS doesn’t have to be
expensive, lengthy and complex

Ever-growing margin pressures, heightened regulation enforcement, complex business processes, globalization, and increased financial scrutiny are forcing pharmaceutical manufacturers to innovate and re-conceptualize even the most elemental business functions, requiring new technologies and business partnerships.

The pressing need to digitize

Cloud based, end-to-end quality management throughout the product value chain is no longer a nice to have – it’s a necessity to increase the speed to market, meet regulatory requirements, and protect both companies and patient safety while meeting increasingly complex regulatory demands.

Digitizing
THE DOT DIFFERENCE

Unmatched Process Coverage

Delivering comprehensive process coverage of core quality, regulatory management, clinical, and drug safety with pre-configured solutions

Connected quality and regulatory compliance

Dot Compliance pre-configured, ready to use eQMS software helps you to decrease your capital investment with a wide range of business process coverage that ensures all quality and compliance data is maintained in one location and with software that is regularly updated based on the new regulatory requirements.

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Quality and compliance enforcement across the entire supply chain

With Dot Compliance eQMS, you can manage your entire quality ecosystem within a single source of truth, promote collaboration, and enable your organization and outsource suppliers to get the required visibility in real-time. You can easily manage your quality processes through the entire product lifecycle from clinical trials, manufacturing, and post-market surveillance.

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Quality Management that drives innovation

Pharmaceutical and biotech companies that rely on Dot Compliance QMS can make real-time decisions with a proactive quality management approach. They can easily translate data from a single source connected to their entire quality processes and analyze it with a click of a button through integrated reports and dashboards and with the most innovative technology that includes AI, Machine learning, IOT integration and big data analytics.

HELPS ENSURE COMPLIANCE WITH THE FOLLOWING REGULATION

  • FDA 21
  • CFR PART 11
  • EU GMP ANNEX 11
  • ISO 9001
  • FDA 21 CFR
  • CFR PART 820

You are in good company.

Best-in-class medical devices companies around the world trust Dot with their QMS

Life without paper is so much easier and reporting to our CEO and key stakeholders is now a quick and swift process.

Franziska Loehrer, Director of Quality & Deputy CEO

Insightec

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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