Manufacturing Industries

AssurX’s content dedicated to the manufacturing industries offers in-depth insights and strategies to enhance quality management, ensure compliance, and improve operational efficiency. This category covers a wide range of topics, including the implementation of enterprise quality management systems, best practices for maintaining regulatory compliance, and innovative solutions for streamlining manufacturing processes. With a focus on continuous improvement and risk mitigation, these articles provide valuable resources for quality management and regulatory compliance professionals looking to optimize their manufacturing operations. Whether you’re dealing with CAPA, Audit Management, or Supplier Management, AssurX delivers the expertise needed to drive excellence in manufacturing.

1 09, 2022

Why an EQMS is Essential for FDA Remote Regulatory Assessments

By |2024-01-13T01:22:12+00:00September 1st, 2022|EU MDR, FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

The global pandemic brought an unexpected change – FDA remote regulatory assessm [...]

25 08, 2022

EU MDR & IVDR Regulation: Where Does the Guidance Stand?

By |2023-03-09T00:38:13+00:00August 25th, 2022|EU MDR, FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

Companies marketing devices in the European Union are facing a perfect storm of [...]

26 07, 2022

How to Establish Sustainable Validation for FDA & EU Compliance

By |2023-09-07T22:44:48+00:00July 26th, 2022|Document Management, FDA Regulated Industries, Manufacturing Industries, Quality Management, Regulatory Compliance Management, Sustainable Validation|

Software validation is historically one of the most difficult compliance activit [...]

13 07, 2022

QMS Configuration vs. Out-of-the-Box: Real-World Considerations

By |2024-06-03T13:28:45+00:00July 13th, 2022|Document Management, FDA Regulated Industries, Manufacturing Industries, Quality Management, Regulatory Compliance Management, Risk Management|

When evaluating an automated QMS, the question to invest in configuration vs. ou [...]

23 06, 2022

AssurX Names Stephanie Ojeda as Director of Product Management for Life Sciences Industry

By |2024-12-31T23:13:03+00:00June 23rd, 2022|AssurX News + Success Stories, FDA Regulated Industries, Manufacturing Industries, Quality Management, Regulatory Compliance Management|

Morgan Hill, CA., June 22, 2022 — AssurX, Inc. (AssurX), a leader in quality man [...]

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