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FDA and EMA Compliance Actions in 2024: A Year in Review (Part 2)
In this continuation of our review of FDA and EMA compliance actions in 2024, we delve deeper into some of the most significant warning...
Hao
Feb 152 min read
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Top Security Breaches of 2024: A Year in Review (Part 2)
As we continue to reflect on the cybersecurity landscape of 2024, it's evident that this year has been marked by numerous significant...
Hao
Feb 152 min read
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FDA and EMA Compliance Actions in 2024: A Year in Review (Part 1)
In 2024, both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) took significant actions to ensure...
Hao
Jan 272 min read
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Top Security Breaches of 2024: A Year in Review (Part 1)
As we look back at 2024, it’s clear that the cybersecurity landscape has been more challenging than ever. Here, we highlight some of the...
Hao
Jan 272 min read
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Nonconformances and CAPA management
Nonconformance management ensures that any deviation from internal procedures, contractual agreements, laws and regulations are...
Hao
Nov 3, 20241 min read
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Data Lifecycle Controls: Authentication and Authorization
Although many companies understand the importance of the Software Development Lifecycle (SDLC) in producing quality software, they often...
Hao
Oct 27, 20241 min read
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Quality Risk Management in Software Updates
In the dynamic world of software development, updates are a constant but they come with their own set of risks. This article explores...
Hao
Aug 11, 20242 min read
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Change Control
A Quality Management System (QMS) is a collection of processes and responsibilities, part of organizational governance, aimed at...
Hao
Jul 23, 20241 min read
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Test Automation
Agile Software Development Software Development - Quality Assurance - Regulatory Compliance Test automation offers numerous benefits that...
Hao
Aug 19, 20232 min read
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Standard Operating Procedures
Computerized Systems Validation (CSV) Part 10 Quality Assurance - CSV - Software Validation - SDLC Once a system is validated it needs to...
Hao
Aug 19, 20231 min read
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Data Migration
Computerized Systems Validation (CSV) Part 9 Quality Assurance - CSV - Software Validation - SDLC Data migration, the transfer of data...
Hao
Jul 15, 20232 min read
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Design Review
Computerized Systems Validation (CSV) Design review is an essential part of computer systems validation. At this phase, the quality of...
Hao
May 1, 20232 min read
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Design Specification
Computerized Systems Validation (CSV) Following the specification of user requirements, the design specification outlines how the system...
Hao
Apr 10, 20231 min read
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Risk Management
Computerized Systems Validation (CSV) This is the fifth in a series of posts on general aspects of Computerized Systems Validation (CSV)...
Hao
Jan 14, 20232 min read
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Requirements Specification
Computerized Systems Validation (CSV) This is the fourth in a series of posts on general aspects of Computerized Systems Validation (CSV)...
Hao
Jan 8, 20232 min read
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Validation Planning
Computerized Systems Validation (CSV) This is the third one in a series of posts on general aspects of Computerized Systems Validation...
Hao
Dec 27, 20221 min read
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Initial Assessments: Part 2
Computerized Systems Validation (CSV) This is the second one in a series of posts on general aspects of Computerized Systems Validation...
Hao
Nov 26, 20223 min read
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Initial Assessments: Part 1
Computerized Systems Validation (CSV) This is the first one in a series of posts on general aspects of Computerized Systems Validation...
Hao
Sep 25, 20223 min read
71 views
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