Atto AuditorThe Audit fit summary of a plant, from its own systems' exports · checked against the problems FDA cites most

Audit fit summary

—%
Audit fit: the share of the checks that came out clear, each weighted by how often FDA cites that problem in its warning letters.

Findings

Most often cited by FDA first · each with the records behind it

Clear

    Not checked yet

    The exports each needs

      The plant's exports

      Add exports CSV or Excel, from any system: MES, QMS, LIMS, training, documents, logbooks, ERP. Each file's columns are recognised; check them below.

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      Your files are read in this browser only: nothing is uploaded or sent anywhere. The Auditor compares their records with each other; it never changes them.

      How much at a time: up to about 300,000 rows of exports together (a year of a busy plant's batch steps, training and lab results): checked in about 5 seconds on an ordinary laptop, more on an older one. Up to about a million rows works with enough memory, but slowly. Excel files of more than 100,000 rows open slowly: export CSV for those. PDFs and scanned pages aren't read yet. For larger plants, or audits that run every day against your systems, ask Atto Pharma about the Atto Appliance on your own premises.

      FileRecognised asRowsColumns read

      The checks come from the Atto Audit Library: Each check finds where a plant's records show the problem; what to do about it stays the plant's quality unit's decision. Atto Pharma eBMR, Atto eLogbooks and Atto QMS are built for 21 CFR Part 11 and EU GMP Annex 11.