1 gmp compliance package software hamilton simplifies the gmp validation process with arc sensors
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GMP Compliance Package SoftwareHamilton Simplifies the GMP Validation Process with Arc Sensors
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GMP in Bio-Pharma Application
Good manufacturing practices (GMP) are the practices required in order to conform to guidelines recommended by agencies that control authorization and licensing for manufacture and sale of food, drug products, and active pharmaceutical products. These guidelines provide minimum requirements that a pharmaceutical or a food product manufacturer must meet to assure that the products are of high quality and do not pose any risk to the consumer or public.
Link with GMP Guidelines: http://ec.europa.eu/health/documents/eudralex/vol-4/index_en.htm
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Operator Workload
Record process value manually! Record errors!
Loss of notes!
Data correlation
Time consuming
Easy to manipulate
Sensor confusion
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Traceability and Sicurity is Important for the Validation!
Security
User identification in the Validation Process
Password protection
User management
Create / Edit or Copy user
User rights management
Sensor assignment
Assign sensor to user
Build sensor groups for user
Validation reports
Stored in data base
View or print and sign
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GMP Compliance Package Solution
Automatic sensor documentation which simplifies the validation process in GMP production
User profile management for better identification on validation reports
Validation report stored in database and printable for signature
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Validation Report
Report information
User and Company information
Sensor information
Validation datae.g. Calibration history specific configuration
Report information/ Signature
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Validation Process with Arc Sensors
GMP Compliance Package supports the Good manufacturing practice guidelines in manufacturing, testing and quality assurance in Bio-/Pharma application.
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Validation Process with Arc Sensors
NOTE: Arc View Handheld and GMP Compliance Package is not intended and specified as a 21 CFR Part 11 tool with digital signature. It is in the sole responsibility of the operator to validate the Arc sensors, print and double sign manually the validation reports.
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SW / FW Update for GMP Functionality
Following parts need to be installed / updated for the new GMP Compliance Functionality:
NOTE: Firmware updates for the Hamilton Arc System are available by agreement with Hamilton Bonaduz AG. Updates are available online or by contacting Hamilton Technical Support directly [email protected]
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Required Parts for the Arc Sensor Validation
Arc View Handheld Package
The package includes Arc View Handheld and Docking Station, Arc Wireless Converter Modbus, the power supply with standard power sockets for Europe, UK, AU and USA, and Arc Cable VP 8 for the wired communication between a sensor and
the Arc View Docking Station.
GMP Compliance Package Software
Available on the website www.hamiltoncompany.com
P/N: 242180 P/N: 243498
Arc Wi Sensor Adapter
Designed for wireless communication between Arc View handheld and Arc sensors. P/N: 242170
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Technical Data GMP Compliance Package
System Requirements
The following system requirements must be met when installing and using the GMP Compliance Package:
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Further Information
Operation Instructions Arc View HandheldDE,FR,EN, IT
GMP Compliance Package FlyerDE, FR,EN, IT
Technical Note “Firmware Update”DE,FR,EN,IT
End customer presentation
Youtube Videos http://www.youtube.com/user/HamiltonBonaduzAG
Visit our Intercompany Cloud or Website for downloading the marketing material: http://www.hamiltoncompany.com/
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Key Points of the GMP Compliance Package
Automatic sensor documentation which simplifies the validation process in GMP production
User profile management for better identification on validation reports
Validation report stored in database and printable for signature
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Thank you for your attention!
Hamilton Bonaduz AG, SwitzerlandHamilton Company, Reno / USA