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Compare leading LIMS software options for GMP laboratories, with practical guidance on data integrity, audit trails, validation, instrument integration, and regulatory expectations. Learn how to assess pharmaceutical LIMS platforms before vendor demos and select a system that fits QC workflows.
Explore how PAS-X MES supports electronic batch records, production control, and data integrity in regulated pharmaceutical manufacturing. Learn which validation, access, audit trail, and lifecycle controls inspectors expect under 21 CFR Part 11 and EU GMP Annex 11.
The U.S. Food and Drug Administration (FDA) has escalated its regulatory dispute with Amgen over the autoimmune drug Tavneos, accusing the company of manipulating clinical trial data and moving toward potential market withdrawal. The case, centered on alleged data integrity