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FDA Compliance Software

AssurX’s FDA Compliance Software automates quality management processes, ensuring adherence to FDA regulations like 21 CFR Part 11. Our platform integrates with enterprise systems, enhancing visibility and control over compliance activities. Experience streamlined workflows and real-time insights to maintain high compliance standards.

19 08, 2021

AssurX Announces Migration to Switch for Cloud-Based QMS and Compliance Platforms
AssurX Announces Migration to Switch for Cloud-Based QMS and Compliance Platforms

AssurX Announces Migration to Switch for Cloud-Based QMS and Compliance Platforms

By AssurX Blog|2024-12-31T23:09:22+00:00August 19th, 2021|AssurX News + Success Stories, Energy & Utilities Industry, FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, SaaS & Cloud Computing|

Powerful Private Cloud Delivers Enterprise Performance and Security MORGAN HILL, [...]

20 04, 2021

Are FDA Warning Letters and 483 Observations About to Spike?
Are FDA Warning Letters and 483 Observations About to Spike?

Are FDA Warning Letters and 483 Observations About to Spike?

By AssurX Blog|2024-06-03T13:31:24+00:00April 20th, 2021|FDA Regulated Industries, Quality Management, Regulatory Compliance Management|

The number of U.S. Food and Drug Administration (FDA) inspections dropped dramat [...]

8 03, 2021

Computer Systems Assurance: Making the Transition from Computer Systems Validation
Computer Systems Assurance: Making the Transition from Computer Systems Validation

Computer Systems Assurance: Making the Transition from Computer Systems Validation

By AssurX Blog|2021-03-08T09:00:15+00:00March 8th, 2021|FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management, Risk Management|

For decades, pharmaceutical and medical device companies have operated under the [...]

4 08, 2020

Why Consider a Cloud QMS for FRACAS Automation?
Why Consider a Cloud QMS for FRACAS Automation?

Why Consider a Cloud QMS for FRACAS Automation?

By AssurX Blog|2020-08-04T05:30:39+00:00August 4th, 2020|FDA Regulated Industries, Manufacturing Industries, Quality Management, Regulatory Compliance Management|

Authors: Sal DiIorio, Principal Consultant, Semi-Tech Group Dave Vadas, VP of Sp [...]

13 07, 2020

A Successful QMS Implementation Requires Clearly Defined Processes
A Successful QMS Implementation Requires Clearly Defined Processes

A Successful QMS Implementation Requires Clearly Defined Processes

By AssurX Blog|2023-09-28T21:18:36+00:00July 13th, 2020|Document Management, FDA Regulated Industries, Manufacturing Industries, Quality Management, Regulatory Compliance Management|

This blog is the second of a three-part series on QMS implementation best practi [...]

6 11, 2019

Have You Transitioned to Quality 4.0?
Have You Transitioned to Quality 4.0?

Have You Transitioned to Quality 4.0?

By AssurX Blog|2023-11-14T20:45:30+00:00November 6th, 2019|FDA Regulated Industries, Manufacturing Industries, Quality Management, Regulatory Compliance Management|

Quality 4.0 focuses on a collaborative approach to quality to ensure that qualit [...]

13 06, 2017

Medical Device Manufacturers Warned For CAPA Non-Compliance
Medical Device Manufacturers Warned For CAPA Non-Compliance

Medical Device Manufacturers Warned For CAPA Non-Compliance

By AssurX Blog|2023-02-27T19:48:41+00:00June 13th, 2017|Archives, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

Three recent warning letters from the Center for Device and Radiological Health [...]

30 05, 2017

FDA Enforcement Trends: Pharmaceutical Manufacturing Quality Focus
FDA Enforcement Trends: Pharmaceutical Manufacturing Quality Focus

FDA Enforcement Trends: Pharmaceutical Manufacturing Quality Focus

By AssurX Blog|2017-05-30T11:50:41+00:00May 30th, 2017|Archives, FDA Regulated Industries, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

After a bit of a lull, the U.S. Food and Drug Administration (FDA) issued a batc [...]

17 04, 2017

Prioritize QMS Process Automation or Risk Failure
Prioritize QMS Process Automation or Risk Failure

Prioritize QMS Process Automation or Risk Failure

By AssurX Blog|2024-07-24T18:19:34+00:00April 17th, 2017|Archives, eMDR, FDA Regulated Industries, Food & Beverage Industry, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

A common pitfall in QMS process automation occurs with a poorly planned process [...]

11 04, 2017

Successful QMS Implementation Requires Clearly Defined Processes
Successful QMS Implementation Requires Clearly Defined Processes

Successful QMS Implementation Requires Clearly Defined Processes

By AssurX Blog|2024-07-01T22:28:02+00:00April 11th, 2017|Archives, eMDR, FDA Regulated Industries, Food & Beverage Industry, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

Industry-leading quality management systems (QMS) are built with clearly defined [...]