Document Management

The “Document Management” category at AssurX focuses on providing effective solutions for managing critical business documents. This section covers strategies for secure storage, streamlined retrieval, and compliance with industry regulations. Key topics include digitizing document workflows, ensuring data integrity, and optimizing access control. With AssurX’s expertise, professionals can improve document handling efficiency, enhance security, and ensure compliance across various sectors, supporting organizational excellence and regulatory adherence.

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 [...]

20 07, 2022

FDA Expands Medical Device Cybersecurity Draft Guidance to Stress Importance of Quality System

By |2024-12-31T23:16:44+00:00July 20th, 2022|Document Management, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

As innovation in medical technology increases, potential cybersecurity threats a [...]

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 [...]

9 12, 2021

3 Essential Document Control Best Practices for Combination Products

By |2024-12-31T23:24:07+00:00December 9th, 2021|Document Management, FDA Regulated Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

Combination products (CPs) have revolutionized drug delivery and patient care, b [...]

10 03, 2020

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

By |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

By |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 [...]

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