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Pharmaceutical Industry

The “Pharmaceutical Industry” category at AssurX focuses on addressing challenges and opportunities within the sector. This section provides insights into quality management, regulatory compliance, and process optimization for drug development and manufacturing. It emphasizes ensuring product safety and efficacy. Discover strategies to navigate complex regulations and enhance operational efficiency. AssurX offers tools and knowledge to help pharmaceutical professionals maintain compliance, improve quality, and drive innovation.

14 10, 2021

How to Use the 5 Whys for Root Cause Analysis
How to Use the 5 Whys for Root Cause Analysis

How to Use the 5 Whys for Root Cause Analysis

By AssurX Blog|2021-10-14T10:46:10+00:00October 14th, 2021|FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management, Risk Management|

Solving problems that occur on the manufacturing floor is a lot like peeling an [...]

1 09, 2021

Root Cause Analysis and CAPA: Creating a Closed-Loop Process
Root Cause Analysis and CAPA: Creating a Closed-Loop Process

Root Cause Analysis and CAPA: Creating a Closed-Loop Process

By AssurX Blog|2024-12-31T23:23:15+00:00September 1st, 2021|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management|

This article examines why a closed-loop root cause analysis (RCA) and corrective [...]

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, [...]

13 07, 2021

How to Simplify CAPA Management with a Cloud-Based QMS
How to Simplify CAPA Management with a Cloud-Based QMS

How to Simplify CAPA Management with a Cloud-Based QMS

By AssurX Blog|2024-03-12T13:42:59+00:00July 13th, 2021|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Risk Management|

Corrective and preventive action (CAPA) violations are the most frequently cited [...]

16 06, 2021

How COVID-19 Is Driving the Shift from Paper to Cloud QMS
How COVID-19 Is Driving the Shift from Paper to Cloud QMS

How COVID-19 Is Driving the Shift from Paper to Cloud QMS

By AssurX Blog|2021-06-16T06:37:17+00:00June 16th, 2021|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management|

When COVID-19 hit in 2020, companies around the world suddenly found themselves [...]

8 06, 2021

Deviation vs. Nonconformance: What’s the Difference?
Deviation vs. Nonconformance: What’s the Difference?

Deviation vs. Nonconformance: What’s the Difference?

By AssurX Blog|2024-03-26T20:19:53+00:00June 8th, 2021|Complaint Management, FDA Regulated Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management, Risk Management|

Recent headlines over wasted COVID-19 vaccines reveal shocking instances of lab [...]

3 12, 2020

How to Meet New EU MDR Requirements for Vigilance and Reporting
How to Meet New EU MDR Requirements for Vigilance and Reporting

How to Meet New EU MDR Requirements for Vigilance and Reporting

By AssurX Blog|2024-01-13T02:07:39+00:00December 3rd, 2020|Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

After a one-year delay due to concerns over a shortage of notified bodies, the n [...]

3 04, 2020

Don’t take your foot off the gas on EU MDR implementation
Don’t take your foot off the gas on EU MDR implementation

Don’t take your foot off the gas on EU MDR implementation

By AssurX Blog|2020-04-03T15:31:23+00:00April 3rd, 2020|eMDR, FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

The coronavirus has had a massive impact on the medical device industry. As a c [...]

10 03, 2020

The Six C’s of a Modern Complaint Management System 2020
The Six C’s of a Modern Complaint Management System 2020

The Six C’s of a Modern Complaint Management System 2020

By AssurX Blog|2020-03-10T07:15:08+00:00March 10th, 2020|Complaint Management, Document Management, eMDR, FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

Regulators such as FDA, European Commission (EC), ISO 13485 require a product c [...]

21 02, 2020

Human Error is a Precipitator for Root Cause Analysis, Not Blame
Human Error is a Precipitator for Root Cause Analysis, Not Blame

Human Error is a Precipitator for Root Cause Analysis, Not Blame

By AssurX Blog|2024-06-03T13:33:05+00:00February 21st, 2020|Document Management, eMDR, FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management, Risk Management, SaaS & Cloud Computing|

Have you ever been part of a process that had a failure or two? Perhaps you’ve b [...]