21 CFR Part 11

AssurX offers comprehensive solutions to ensure compliance with 21 CFR Part 11, facilitating secure electronic records and signatures for FDA-regulated industries. Our platform enhances data integrity, accountability, and operational efficiency.

5 03, 2024

Top Considerations for Compliance Management Tools

By |2025-03-18T09:27:36+00:00March 5th, 2024|Audit Management, Corrective Action (CAPA), Document Management, FDA Regulated Industries, Food & Beverage Industry, Medical Device Industry, Pharmaceutical Industry, Quality Management|

Implementing an automated compliance management solution is a mammoth undertakin [...]

22 02, 2024

Why Change Control is Important: Tips for Manufacturers

By |2025-03-18T09:27:45+00:00February 22nd, 2024|Audit Management, Corrective Action (CAPA), Document Management, FDA Regulated Industries, Food & Beverage Industry, Medical Device Industry, Pharmaceutical Industry, Quality Management|

Change is a constant in manufacturing, and is both necessary for innovation and [...]

3 04, 2017

FDA Warning Letters Emphasize Document Control System Compliance

By |2025-04-03T01:32:10+00:00April 3rd, 2017|Archives, FDA Regulated Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management, Risk Management|

First-quarter 2017 Food and Drug Administration (FDA) warning letters emphasize [...]

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