Quality Management System

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.

30 10, 2024

Preparing for ISO 13485 Harmonization: Where Do Things Stand Today?

By |2025-04-04T02:28:32+00:00October 30th, 2024|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management|

In January 2024, the U.S. Food and Drug Administration (FDA) issued a final rul [...]

9 10, 2024

The Role of Technology in Supporting ALCOA Principles: Strengthening Data Integrity in Life Sciences with Quality Management Software

By |2025-04-04T02:28:48+00:00October 9th, 2024|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management|

In the highly regulated world of life sciences, data integrity is not optional [...]

29 08, 2024

Ways to Influence Stakeholder Buy-In During the CAPA Process

By |2025-04-04T01:28:11+00:00August 29th, 2024|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management|

How can a quality manager secure stakeholder engagement and hold individuals ac [...]

22 08, 2024

CAPA is a Process, Not a Project: 3 Key Strategies for Success

By |2025-04-04T01:30:11+00:00August 22nd, 2024|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management|

The challenge of the quality manager is to convince stakeholders of their respo [...]

15 08, 2024

Overcoming Deviations and Non-Conformances in Manufacturing: The Power of Automating Quality and Compliance

By |2025-05-07T15:17:48+00:00August 15th, 2024|Deviation, FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management|

Manufacturers widely view process improvement frameworks like Lean as the solut [...]

26 07, 2024

How to Use the QMS to Support Lean Manufacturing Initiatives?

By |2025-04-04T02:24:45+00:00July 26th, 2024|Corrective Action (CAPA), Document Management, FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Quality Management|

Manufacturers widely view process improvement frameworks like Lean as the solut [...]

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