Quality Management System Solutions by AssurX

AssurX Quality Management Systems (QMS) provide comprehensive solutions to automate and streamline compliance processes. Our platform enhances visibility and control, ensuring adherence to industry standards like ISO 9001 and FDA regulations. Experience seamless integration and real-time insights to improve quality management across your organization.

18 06, 2019

FDA to Sunset Alternative Summary Reporting (ASR) Program
FDA to Sunset Alternative Summary Reporting (ASR) Program

FDA to Sunset Alternative Summary Reporting (ASR) Program

By AssurX Blog|2023-03-08T23:16:10+00:00June 18th, 2019|eMDR, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

The FDA has announced an end to the alternative summary reporting (ASR) program [...]

30 05, 2019

Postmarket Surveillance is Most Effective when Approached as an Enterprise Interest
Postmarket Surveillance is Most Effective when Approached as an Enterprise Interest

Postmarket Surveillance is Most Effective when Approached as an Enterprise Interest

By AssurX Blog|2024-11-20T20:17:20+00:00May 30th, 2019|FDA Regulated Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

FDA regulation 21 part 822 lays out the process, the rules, and the products th [...]

20 11, 2018

Keeping your Enterprise QMS Implementation Project on Schedule
Keeping your Enterprise QMS Implementation Project on Schedule

Keeping your Enterprise QMS Implementation Project on Schedule

By Eric Cooper|2018-11-20T15:22:28+00:00November 20th, 2018|Quality Management, Regulatory Compliance Management|

Due dates. Everyone has them, everyone wants them. Whether it’s building a house [...]

7 08, 2018

AssurX Receives HIPAA and HITECH Compliance Type 1 Attestation
AssurX Receives HIPAA and HITECH Compliance Type 1 Attestation

AssurX Receives HIPAA and HITECH Compliance Type 1 Attestation

By AssurX Blog|2018-08-07T11:20:54+00:00August 7th, 2018|FDA Regulated Industries, Quality Management, Regulatory Compliance Management, Risk Management|

Morgan Hill, CA – August 8, 2018 - AssurX,Inc. (AssurX), a leading provider of e [...]

24 04, 2018

Visit AssurX at the ASQ World Conference on Quality & Improvement (WCQI)
Visit AssurX at the ASQ World Conference on Quality & Improvement (WCQI)

Visit AssurX at the ASQ World Conference on Quality & Improvement (WCQI)

By AssurX Blog|2024-07-01T22:17:54+00:00April 24th, 2018|Energy & Utilities Industry, FDA Regulated Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

AssurX, a leader in quality management software systems, will exhibit at the 201 [...]

7 02, 2018

2017 Recap: FDA Warning Letter Observations and Trends
2017 Recap: FDA Warning Letter Observations and Trends

2017 Recap: FDA Warning Letter Observations and Trends

By AssurX Blog|2024-06-25T18:32:49+00:00February 7th, 2018|Quality Management, Regulatory Compliance Management|

In 2017, the FDA released 476 warning letters. Top FDA warning letter violations [...]

2 11, 2017

AssurX Announces Corporate-Wide HIPAA Compliance
AssurX Announces Corporate-Wide HIPAA Compliance

AssurX Announces Corporate-Wide HIPAA Compliance

By AssurX Blog|2017-11-02T09:30:40+00:00November 2nd, 2017|FDA Regulated Industries, Regulatory Compliance Management|

Morgan Hill, CA – November 2, 2017 - AssurX, Inc., a leading provider of enterpr [...]

28 09, 2017

5 Pillars of Modern Enterprise Quality Management Systems
5 Pillars of Modern Enterprise Quality Management Systems

5 Pillars of Modern Enterprise Quality Management Systems

By Sal Lucido|2017-09-28T08:45:08+00:00September 28th, 2017|Energy & Utilities Industry, FDA Regulated Industries, Regulatory Compliance Management|

After decades spent helping companies develop and implement enterprise quality m [...]

15 08, 2017

FDA Warning Letters: First Half of 2017 Trends
FDA Warning Letters: First Half of 2017 Trends

FDA Warning Letters: First Half of 2017 Trends

By AssurX Blog|2023-02-27T19:57:39+00:00August 15th, 2017|Quality Management, Regulatory Compliance Management|

The FDA released 225 warning letters in the first half of the year. AssurX, a QM [...]

26 07, 2017

New QMS Automation Webinar Released By AssurX
New QMS Automation Webinar Released By AssurX

New QMS Automation Webinar Released By AssurX

By AssurX Blog|2024-07-01T22:20:07+00:00July 26th, 2017|AssurX News + Success Stories, Quality Management, Regulatory Compliance Management|

AssurX releases a pre-recorded QMS automation webinar entitled “Automating Your [...]