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SOC 2 Compliance

August 7, 2025/

What Is SOC 2? SOC 2 (System and Organization Controls 2) is a cybersecurity compliance framework developed by the AICPA (American Institute of Certified Public Accountants). It’s designed for service providers that store, process, or transmit client data, especially in...

Guide to ISAE 3402 and SOC 2

August 6, 2025/

Beginner’s Guide to ISAE 3402 and SOC 2 — what they are, how they’re used, who needs them, and how to prepare for them. 🔐 What is ISAE 3402 and SOC 2? — Basic Definitions 1. ISAE 3402 (International Standard...

May 17, 2025/

In today’s dynamic regulatory landscape, organizations face constant challenges in staying compliant with ever-changing laws, guidelines, and industry standards. The risks of non-compliance can lead to financial penalties, operational delays, and reputational damage. This is where Regulatory Intelligence (RI) comes...

CAPA: Seven Steps for an Effective Process

November 22, 2024/

In the pharmaceutical industry, a leading Corrective and Preventive Action (CAPA) process is essential for ensuring product quality and regulatory compliance.  This blog post shares a seven-step approach that outlines the key stages for effective CAPA management. Read on to...

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