03 Oct

Genel

AI in the Age of Regulated Work with ALCOA+ Principles

• 3 October 2025
• By admin

TL;DR What changes with AI: You now create records at three points: training data, prompts, and outputs. Treat each as controlled. ...

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26 Sep

Genel

CSV vs CSA in 2025: What Changes and What Doesn’t

• 26 September 2025
• By admin

Computer software assurance is the FDA’s risk-based way to build confidence in software that supports production and quality activities...

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15 Sep

Genel

Metrics that Matter in Validation Lifecycle Management

• 15 September 2025
• By admin

Validation lifecycle management is not a one-off task. It is the system that plans, builds, tests, releases, and maintains GxP changes ...

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05 Sep

Genel

Data Migration Validation for Regulated Systems

• 5 September 2025
• By admin

CSV data migration is the controlled process of moving regulated records between systems and proving, with evidence, that the records k...

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01 Sep

Genel

FDA’s Guidance on Data Integrity

• 1 September 2025
• By admin

FDA’s guidance on data integrity lays out how drug makers can ensure their records are complete, accurate, and reliable. In this bl...

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22 Aug

Genel

Best Practices and Challenges for Computerized System Validation in Pharma

• 22 August 2025
• By admin

Computerized system validation is the process of proving that software and hardware used in pharmaceutical operations do exactly what t...

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15 Aug

Genel

Challenges in Maintaining Data Integrity and How to Overcome Them

• 15 August 2025
• By admin

Challenges in maintaining data integrity is important for reliable decision making. When you can maintain data integrity, every report,...

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03 Aug

Genel

Implementing Data Integrity Policies in Pharmaceutical

• 3 August 2025
• By admin

Implementing data integrity policies in pharmaceutical means keeping your data clear and safe. So that, you can protect your patients, ...

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28 Jul

Genel

An Introduction to Computerized System Validation

• 28 July 2025
• By admin

Computerized system validation is the backbone of safe, compliant digital operations in regulated industries.  In this blog, yo...

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14 Jul

Genel

The Importance of ALCOA Principles in Pharma

• 14 July 2025
• By admin

ALCOA principles are the five pillars, Attributable, Legible, Contemporaneous, Original, and Accurate, that ensure reliable data in reg...

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