Most pharmaceutical plants run their MES, QMS, LIMS, training, document and logbook systems from different vendors. Each tells its own truth, and the truths don't always match: a step signed by someone whose training on that SOP revision came later, equipment used while its logbook shows the cleaning hold expired, a batch released while its deviation was still open, a component lot released on the supplier's certificate alone. FDA cites exactly these mismatches; no single system sees them.
The Atto Auditor reads the exports of all of them, compares their records, and gives your plant's Audit fit summary: each problem FDA cites most, with the records that show it, ranked by how often FDA cites it in its warning letters (298 letters, 2023-11-06 to 2026-10-27).
Try it on the demo plant
A made-up plant, with exports as five different systems give them and eight gaps FDA often finds. Open a finding to see the records behind it.
Already using Atto Pharma? Open Atto Auditor in your app's menu, or pharma-manufacturing.today/auditor.html: it runs for your company, with the same sign-in.
What it checks first
| Problem | Records compared | FDA letters |
|---|---|---|
| Components released without identity testing (relying on the supplier's CoA) | ERP / inventory, LIMS / CDS | 156 · 52.3% |
| Quality unit not approving procedures, records and releases | Documents (DMS), QMS, ERP / inventory, MES / eBMR | 150 · 50.3% |
| Products made with no process validation | MES / eBMR, Documents (DMS) | 128 · 43.0% |
| No ongoing stability programme for products on the market | ERP / inventory, LIMS / CDS | 104 · 34.9% |
| Batches released without all required tests | ERP / inventory, LIMS / CDS | 98 · 32.9% |
| Investigations inadequate: root cause, scope and other batches not covered | QMS, MES / eBMR | 89 · 29.9% |
Works with the exports of the systems plants use
The Auditor reads CSV and Excel exports and reports. If your system can export a report to CSV or Excel, the Auditor can read it: it recognises each export from its column names, and you confirm the columns once. For example, the exports of:
MES and eBMR
- Körber Werum PAS-X
- Siemens Opcenter Execution Pharma
- Rockwell Automation FactoryTalk PharmaSuite
- Emerson Syncade
- Honeywell POMSnet
- MasterControl Manufacturing Excellence
- Tulip
- Apprentice Tempo
QMS
- Veeva Vault QMS
- Honeywell TrackWise
- MasterControl Quality Excellence
- Hexagon ETQ Reliance
- Caliber QAMS
- AmpleLogic eQMS
LIMS and chromatography data
- LabWare LIMS
- LabVantage
- Thermo Fisher SampleManager
- STARLIMS
- CaliberLIMS
- Waters Empower
- Agilent OpenLab
- Thermo Fisher Chromeleon
Documents and training
- Veeva Vault QualityDocs
- Veeva Vault Training
- MasterControl Documents and Training
- OpenText Documentum
- SAP SuccessFactors Learning
- Cornerstone
ERP, inventory and maintenance
- SAP S/4HANA (QM, PM, MM)
- Oracle E-Business Suite
- Oracle Fusion Cloud
- Microsoft Dynamics 365
- Infor
- IBM Maximo
The product names above are trademarks of their owners. Siddhi LLC is not affiliated with, endorsed by or sponsored by any of them; they are listed only to say which systems' exports the Atto Auditor reads.
Your records stay with you
The Auditor reads the exports in your browser: nothing is uploaded to Siddhi LLC or anyone else, and it never changes your records. What to do about each finding stays your quality unit's decision. Atto Pharma eBMR, Atto eLogbooks and Atto QMS are built for 21 CFR Part 11 and EU GMP Annex 11.
Find these problems in your own records before an inspector does
The Atto Auditor compares the exports of your MES, QMS, LIMS, training, documents, logbooks and ERP, whichever vendors made them, and gives your plant's Audit fit summary: each problem FDA cites, with the records that show it.