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| Brand | LabHawk |
|---|---|
| Origin | China |
| Manufacturer Type | Authorized Distributor |
| Model | LabHawk |
| Software Type | GxP-Compliant Excel Add-in for 21 CFR Part 11 |
| Regulatory Scope | FDA 21 CFR Part 11, Annex 11, ALCOA+ Principles, GMP/GLP Data Integrity Requirements |
| Deployment | On-premises or virtualized Windows environment (64-bit) |
| Supported Excel Versions | Microsoft Excel 2016–2021, Microsoft 365 (Desktop App) |
| User Authentication | LDAP/Active Directory integrated |
| Audit Trail | Immutable, time-stamped, user-attributed, exportable to CSV/PDF |
| Electronic Signature | PKI-based, role-enforced, with reason-for-change field (5–200 characters) |
| Version Control | Automatic versioning on save |
| Print Control | Centralized print logging |
| Search Capability | Full-text and metadata indexing across unlimited .xlsx/.xls files (local or network file shares) |
| Brand | Scintomics |
|---|---|
| Origin | Germany |
| Model | GRP 2V–6V Modular System |
| Configuration | Fully modular (base module + up to 5 valve modules + up to 4 syringe-driven distribution modules) |
| Regulatory Design Basis | Compliant with GMP, ISO 13485, and applicable IEC 61010-1 safety standards for Class II medical device manufacturing environments |
| Software Architecture | Windows-based control interface with audit trail, user access levels, and electronic signature support per FDA 21 CFR Part 11 requirements |
| Radiation Shielding | Integrated lead–tungsten composite shielding (≥15 cm Pb-equivalent for 511 keV photons) |
| Operating Environment | Designed for hot cell integration (Class C cleanroom compatible, IP54-rated modules) |
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