Monthly Archives: July 2022

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FDA Expands Medical Device Cybersecurity Draft Guidance to Stress Importance of Quality System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 |2022-07-20T07:00:42+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 |2024-01-13T02:05:02+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 [...]

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