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CSV & Data Integrity

Mastering Computerised System Validation: An In-Depth Review of EU GMP Annex 11

Discover how the increased use of computerized systems and new technologies like AI and Machine Learning are reshaping Computerized System Validation.

CSV & Data Integrity

The Importance of Gap Assessment on Data Integrity Before an FDA Inspection

Ensure compliance with FDA regulations through a Data Integrity Gap Assessment. Identify improvement areas, enhance data quality.

CSV & Data Integrity

Navigating Pharmaceutical Data Management: ISO IDMP with RIMS and eDMS

Learn how pharmaceutical companies can navigate ISO IDMP requirements with RIMS and eDMS. Explore the benefits of digitized processes

CSV & Data Integrity

AVEVA PI and Real-time Data Collection

AVEVA PI (formerly OSIsoft, recently acquired by AVEVA) is one of the most frequently used platforms for real-time data management.

CSV & Data Integrity

Begin with the End in Mind: Back to the Focus of Quality - About the Application of GAMP5 Ed02 in CSV Projects

The best way to apply the GAMP5 second edition in CSV Projects - Begin with the End in Mind

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.