GMP Compliance Package Software Hamilton Simplifies the GMP Validation Process with Arc Sensors

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

Operator Workload Record process value manually! Record errors! Data correlation Easy to manipulate Loss of notes! Sensor confusion Time consuming

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

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

Validation Report Report information User and Company information Sensor information Validation data e.g. Calibration history specific configuration Report information/ Signature

Validation Process with Arc Sensors GMP Compliance Package supports the Good manufacturing practice guidelines in manufacturing, testing and quality assurance in Bio-/Pharma application. Hamilton GMP Compliance Package is a validation software that provides simple management functionality of user profiles and validation reports for calibration, verification, configuration and communication within the GMP regulatory for all Arc sensors. A new user interface on the Arc View Handheld was developed to support users in selecting the sensor’s data from the process.

Validation Process with Arc Sensors It simplifies the validation process and support the user by providing all relevant sensor information automatically to the validation reports stored in the GMP Compliance Package database. 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.

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 contact@hamilton.ch

Required Parts for the Arc Sensor Validation GMP Compliance Package Software Available on the website www.hamiltoncompany.com 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. P/N: 242180 P/N: 243498 Arc Wi Sensor Adapter Designed for wireless communication between Arc View handheld and Arc sensors. P/N: 242170

Technical Data GMP Compliance Package System Requirements The following system requirements must be met when installing and using the GMP Compliance Package:

Further Information Operation Instructions Arc View Handheld DE,FR,EN, IT GMP Compliance Package Flyer DE, 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/

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

Thank you for your attention! Hamilton Company, Reno / USA Hamilton Bonaduz AG, Switzerland