21 CFR Part 11 — VLMcare Journal

Industry Notes · October 4, 2026 · 5 min read

How VLMcare Supports and Enforces ALCOA++ Data Integrity Principles

How VLMcare's object-based validation platform maps to the ten ALCOA++ data integrity principles, from attributable e-signatures to live, always-current traceability.

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Industry Notes · September 1, 2026 · 5 min read

Current FDA Guidance on Governed AI in Validation

The current guidance from FDA and EMA on AI in life sciences manufacturing for validation teams. Bottom line: the practice of risk-based validation hasn't changed with AI, and why the barrier to AI use is a myth.

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Industry Notes · August 1, 2026 · 5 min read

The Regulations and Guidelines of Data Integrity in GXP Environments

How GAMP 5, PIC/S PI 041-1, MHRA, and FDA guidance build on ALCOA+ principles to define data integrity in GxP environments for validation programs.

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