Control de calidad en la

Industria Farmacéutica

1

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

4

Incoming goods in the Pharmaceutical Industries

Market Requirements

Proofreading of Folder Boxes, Leaflets, Labels and more…

5

Data validation in theArt Works

Press Sheets in the production

The Validation Process

MasterDocument

Scan / PDF Test Object

Adjustment

6

Protokoll / Audit

Review and Judging

First Step

Scan / PDF Test Object

7

1. Braille Measurement ResultText decoding (more than 20 languages, increasing list) and

Second Step

Reference

Adjustment

8

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

9

Final Step

Protokoll / Audit

10

A2 Flatbed-Scanner

System Components

11

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

12

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

13

� Proven system in GxP environment

FallerPharma Service Concept

BIOTESTFrom nature to life

Installation Base

14

TISKARNANOVO MESTO

VALKARTON

Italia

Braille Proof Reading Technology

15