GAMP-compliant image processing according to FDA and GMP guidelines

Plug&Play system for GMP-compliant implementation of vision applications according to the standards of FDA 21 CRF Part 11 and EU GMP Guidance Annex 11

Safeguarding of important process steps through electronic signature (recipe management, versioning). Archiving and complete traceability of user actions requiring proof (audit trail). Login only for authorized employees. Authorization concept linked to domain concept. Realization based on Siemens PM-Control.

References:

pharmaceutical industry, life science industry, packaging industry

Price description:

GampBOX basic version: from € 20.000,-- (includes: Simatic MicroboxPC / user interface with WinCC / AuditTrail / recipe management / GampBox - camera license (up to 4 cameras per GampBox possible)) Optional: Complete qualification documentation / application-specific image processing (camera system(s), lighting, inspection program, project planning and commissioning, accompanying qualification)

Price: on request

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#FDA #GMP #Pharma
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