Tag: computerized system validation

Trends in Monitoring Device Technology for Cold Chain

Trends in Monitoring Device Technology for Cold Chain Trends in Monitoring Device Technology for Cold Chain In the pharmaceutical industry, ensuring product integrity throughout the supply chain is paramount. One of the most critical aspects is the validation of computerized…

SOP for In-Process Controls on Blister Packaging Lines

SOP for In-Process Controls on Blister Packaging Lines SOP for In-Process Controls on Blister Packaging Lines This article provides a comprehensive step-by-step tutorial on the validation lifecycle for in-process controls on blister packaging lines, especially focusing on computerized system validation…

Mapping Cleanroom Zones for Optimal Sampling Points

Mapping Cleanroom Zones for Optimal Sampling Points Mapping Cleanroom Zones for Optimal Sampling Points In the highly regulated pharmaceutical and biologics industries, the validation process is a critical function that ensures the quality, safety, and efficacy of products. An essential…

Linking Change Control Numbers to Protocol Revisions

Linking Change Control Numbers to Protocol Revisions Linking Change Control Numbers to Protocol Revisions In the pharmaceutical industry, maintaining compliance with regulatory expectations is paramount, especially when it comes to computerized system validation (CSV). This comprehensive tutorial is aimed at…

VMP Harmonization in Global Contract Manufacturing Networks

VMP Harmonization in Global Contract Manufacturing Networks VMP Harmonization in Global Contract Manufacturing Networks In the face of increasing globalization in the pharmaceutical industry, the need for a standardized approach to validation through a Validation Master Plan (VMP) has become…

Data Integrity Training Programs for QA and IT

Data Integrity Training Programs for QA and IT Data Integrity Training Programs for QA and IT In the highly regulated pharmaceutical industry, ensuring data integrity within computerized systems is critical for compliance with global regulations such as FDA guidelines, EMA…

Heat Exchanger and Jacketed Vessel Qualification

Heat Exchanger and Jacketed Vessel Qualification Heat Exchanger and Jacketed Vessel Qualification Heat exchangers and jacketed vessels play a crucial role in various pharmaceutical processes, from temperature control during drug formulation to the heating and cooling of substances. The qualification…

How to Trend Process Parameters Across Lots for CPV

How to Trend Process Parameters Across Lots for CPV How to Trend Process Parameters Across Lots for CPV Continued Process Verification (CPV) is an essential component of the pharmaceutical validation lifecycle that ensures processes remain in a state of control…