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Document Management

7 02, 2023

Planning for Successful Preparation of the NERC CIP ERT
Planning for Successful Preparation of the NERC CIP ERT

Planning for Successful Preparation of the NERC CIP ERT

By Kathryn Wagner|2023-02-07T08:00:02+00:00February 7th, 2023|Document Management, Energy & Utilities Industry, NERC Compliance, Quality Management, Regulatory Compliance Management|

Cybersecurity regulations in the energy industry create a constantly evolving ch [...]

31 01, 2023

Tips for Preparing for an ISO Certification Audit
Tips for Preparing for an ISO Certification Audit

Tips for Preparing for an ISO Certification Audit

By sojeda|2023-01-31T07:12:00+00:00January 31st, 2023|Document Management, Manufacturing Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

Recent ISO data shows a growing number of certificates being issued across all s [...]

29 09, 2022

5 Building Blocks You Need for a Quality 4.0 Foundation
5 Building Blocks You Need for a Quality 4.0 Foundation

5 Building Blocks You Need for a Quality 4.0 Foundation

By sojeda|2022-09-29T15:05:23+00:00September 29th, 2022|Complaint Management, Document Management, Manufacturing Industries, Quality Management|

Market changes and disruptions such as the global pandemic are driving companies [...]

26 07, 2022

How to Establish Sustainable Validation for FDA & EU Compliance
How to Establish Sustainable Validation for FDA & EU Compliance

How to Establish Sustainable Validation for FDA & EU Compliance

By sojeda|2022-07-26T08:38:56+00:00July 26th, 2022|Document Management, FDA Regulated Industries, Manufacturing Industries, Quality Management, Regulatory Compliance Management|

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FDA Expands Medical Device Cybersecurity Draft Guidance to Stress Importance of Quality System
FDA Expands Medical Device Cybersecurity Draft Guidance to Stress Importance of Quality System

FDA Expands Medical Device Cybersecurity Draft Guidance to Stress Importance of Quality System

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

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

By Sal Lucido|2022-07-13T08:23:37+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 [...]

27 01, 2022

3 Phases of EQMS Implementation and 12 Strategies for Success
3 Phases of EQMS Implementation and 12 Strategies for Success

3 Phases of EQMS Implementation and 12 Strategies for Success

By Sal Lucido|2022-01-27T08:22:23+00:00January 27th, 2022|Document Management, FDA Regulated Industries, Quality Management, Regulatory Compliance Management, Risk Management|

Part 3 of a three-part quality automation blog series We live in a time of rapid [...]

9 12, 2021

3 Essential Document Control Best Practices for Combination Products
3 Essential Document Control Best Practices for Combination Products

3 Essential Document Control Best Practices for Combination Products

By Sal Lucido|2021-12-09T11:03:29+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 [...]

18 05, 2021

Connecting Your Document Control System for Employee Training Management
Connecting Your Document Control System for Employee Training Management

Connecting Your Document Control System for Employee Training Management

By AssurX Blog|2021-05-18T07:00:35+00:00May 18th, 2021|Document Management, Quality Management|

When companies implement an enterprise quality management system (EQMS), one of [...]

6 04, 2021

Elements of an Effective Supplier Scorecard
Elements of an Effective Supplier Scorecard

Elements of an Effective Supplier Scorecard

By AssurX Blog|2021-04-06T07:00:23+00:00April 6th, 2021|Complaint Management, Document Management, Manufacturing Industries, Quality Management, Regulatory Compliance Management, Risk Management|

Imagine if your plant is starting work on a big order. You’ve just been advised [...]