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CSV & Data Integrity

How to Validate a Chromatographic Data System (CDS)

Understand the importance of Computerized System Validation and how it differs from Factory Acceptance Testing.

CSV & Data Integrity

The Main Differences between 1st and 2nd Editions of GAMP® 5

Critical Thinking has been introduced in GAMP5 to make testing more efficient and question the system. Want to know more about this important change?

CSV & Data Integrity

Data Integrity Compliance: How to reach the Status of Compliant

Data Integrity Compliance can be achieved through a 3 step process; Traceability, Correct Implementation and Monitoring.

CSV & Data Integrity

GAMP® 5 Guide 2nd Edition Release

Gamp 5 Version 2 released in July 2022 brings new updates for computerized systems in the Life Science industry.

CSV & Data Integrity

Regulatory Trends in Computer Systems Validation and Data Integrity

After Covid-19 Pandemic, with FDA almost set to start remote auditing, is your company inspection ready?

CSV & Data Integrity

A comparison between CSV Guideline / regulations in Japan, India and China

Find out the differences between CSV guidelines and regulations in Japan, India and China.

CSV & Data Integrity

A snapshot of Serialization in Pharmaceutical Industry

Serialization and aggregation to fight counterfeiting and to enhance the level of control of the entire supply chain related to pharmaceutical.