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CSV & Data Integrity

Data Integrity and Data Governance in the Quality Control Laboratory

The importance of Data Governance and Data Integrity, in maintaining paper and electronic records at the Quality Control Laboratory.

CSV & Data Integrity

ALCOA++: What’s New, What’s Important, and  What You Need to Know

What does the acronym Alcoa++ stand for?

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.