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AI's Impact on Cybersecurity and the Need for Effective Governance
Recent advancements in Artificial Intelligence (AI) have significantly impacted cybersecurity. It is giving defenders powerful new ways to detect and respond to threats while expanding the attack surface within organizations and providing attackers new tools to scale, automate, and personalize attacks. For small and mid-sized organizations, this shift can feel overwhelming—especially when AI is adopted quickly across teams without clear rules. AI-powered cybersecurity shield
Hao
Mar 253 min read


C-realize helps medAspis achieve combined ISO9001 and ISO27001 certification with an integrated quality management system
medAspis, a pioneering pharmtech company, stands at the forefront of the market in providing cutting-edge Software as a Service (SaaS)...
Hao
Aug 3, 20252 min read


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 15, 20252 min read


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 15, 20252 min read


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 27, 20252 min read


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 27, 20252 min read


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


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


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


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
Test Automation
Agile Software Development Software Development - Quality Assurance - Regulatory Compliance Test automation offers numerous benefits that...
Hao
Aug 19, 20232 min read
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
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
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
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
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
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
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
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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