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| Brand | Sievers (Veolia) |
|---|---|
| Origin | USA |
| Manufacturer Type | Original Equipment Manufacturer (OEM) |
| Product Category | Imported |
| Model | DataGuard |
| Software Type | Regulatory-Compliant Laboratory Data Integrity Software |
| Regulatory Compliance | FDA 21 CFR Part 11, Annex 11, ALCOA+ Principles |
| Brand | Sievers (Veolia) |
|---|---|
| Origin | USA |
| Manufacturer | Yes |
| Import Status | Imported |
| Model | DataShare Elite |
| Software Type | Laboratory Data Management & Compliance Software |
| Regulatory Compliance | 21 CFR Part 11, ALCOA+, cGMP |
| Compatible Instruments | Sievers M9/M9e, M500, 900, 500 RL, CheckPoint |
| Deployment | Windows 10/Server 2016–2019 |
| Database Engine | Microsoft SQL Server Express (included) |
| Authentication | Active Directory (AD) Integration |
| Audit Trail | Full electronic audit trail with time-stamped, immutable records |
| Electronic Signatures | Role-based e-signature support for calibration, validation, and sample release |
| LIMS Integration | Standardized API and CSV export for seamless LIMS interoperability |
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