A Quick Guide to 21 CFR Part 11 and its compliance

As with most digital management regulations, 21 CFR (Code of Federal Regulations) issued by United States Food and Drug Administration (FDA) can seem complicated if the regulatory organizations are not well versed with their systems…

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Business Continuity Plan for GxP Compliant Computerised systems

For the availability of computerised systems critical processes, provisions should be made to ensure continuity of support for those processes in the event of a system breakdown (e.g., a manual or alternative system). The time…

agaram Agaramtech 0

Data Integrity

Data Integrity Data integrity, an area of increasing priority in today’s laboratory world and “The focus area” when it comes to regulatory compliances such as 21 CFR Part 11 and Eudralex Annex 11. Considering the number of warning…

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Qualis Inventory Management System

Deploy and scale up from a simple single to multi-user environment with “Qualis Inventory Management System” QUALIS INVENTORY Qualis Inventory is a web-based Inventory Management System designed based on guidelines for GLP and FDA. Designed…

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Author: agaram

A Quick Guide to 21 CFR Part 11 and its compliance

Business Continuity Plan for GxP Compliant Computerised systems

Data Integrity

Qualis Inventory Management System

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