control de calidad en la industria farmacéutica · 2015. 1. 12. · general specifications of...
TRANSCRIPT
Control de calidad en la
Industria Farmacéutica
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The Portfolio
2
A typical Application for Text Proof
Medcine
Medikament
Médicament
ilaç
� Generate a master GI� Country specific localisation � Compose a GI
3
Medicamento
φάρµακο
ilaç
лека�рство
� Verify master against composed GI
System Structure and Process Steps
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Incoming goods in the Pharmaceutical Industries
Market Requirements
Proofreading of Folder Boxes, Leaflets, Labels and more…
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Data validation in theArt Works
Press Sheets in the production
The Validation Process
MasterDocument
Scan / PDF Test Object
Adjustment
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Protokoll / Audit
Review and Judging
First Step
Scan / PDF Test Object
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1. Braille Measurement ResultText decoding (more than 20 languages, increasing list) and
Second Step
Reference
Adjustment
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Text decoding (more than 20 languages, increasing list) andheight measurement according to DIN EN 15823:2010. Dots outof tolerance are highlighted in red. Due to an intelligentcalibration algorithm DotScan is able to inspect the height ofeach Braille Dot down to 0.02 mm accuracy.
3. Code ResultUp 30 codes including Data Matrix are supported
Object
2. Text DeviationText deviations are highlighted in red.
Differences
Third Step
Review and Judging
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Final Step
Protokoll / Audit
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A2 Flatbed-Scanner
System Components
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A0 Scanner
Colour-PrinterBraille-CubeDB-ServerFile-Server
General specifications of Pixel Proof
Feature and functional descriptions
SOP of validation SOP of risk analyze
User requirements / functional specification, risk analysis
Developer’s level User’s level
Technical base &SW configuration
Test schedule, tests on user level
User RequirementsURS
Functional SpecificationFS
Configuration SpecificationCS
Procedures V-Model
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SW design & documentation User manual tutorialDesign SpecificationDS
SW Release
� Program login on 3 user levels
� Windows user access protection
� Digital signature
� Program with integrated Audit Trail
Pixel Proof is 21 CFR Part 11 compatible
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� Proven system in GxP environment
FallerPharma Service Concept
BIOTESTFrom nature to life
Installation Base
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TISKARNANOVO MESTO
VALKARTON
Italia
Braille Proof Reading Technology
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