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Paperless validation and process qualification for regulated sites

Take equipment, process, cleaning and analytical-method validation protocols out of Word. Execute them with cell-level tolerance checks, live OOS detection and automatic statistics (RSD, Cp, Cpk).

Validation and data management
EU GMP Annex 1521 CFR Part 11GAMP 5 (2nd ed.)
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Validation Management System

Axon · VMS

Illustrative interface rendering. Real screens and recordings live on the module pages.

Protocol execution with live OOS detectionReal product screen
Protocol execution with live OOS detection
Template editor: bulk field setupReal product screen
Template editor: bulk field setup
Screen recording: adding bulk input fields

Validation Management System

Who it is for: Validation managers, process engineers, qualification teams (IQ/OQ/PQ)

  1. Dynamic data grid with instant OOS detection

    Catches out-of-tolerance measurements (e.g. 5.800 g > upper limit 5.7159 g) with a red outline the moment they are entered, stopping the error at source.

  2. Automatic statistics engine

    Produces mean, min, max and relative standard deviation (RSD) live from defined formulas, no calculator needed.

  3. Cleaning validation and residue limits

    Manages MACO, swab and rinse test analyses with an integrated limit calculator on one screen.

  4. Template and formula engine

    Word/PDF import, bulk field definition across 40+ cells, cell-level limits, role-based access and formulas such as =AVG() and =RSD().

One platform, many modules.

Make audit day an ordinary day.

In a short demo we look at your own use case together.

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