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SherpaPharma

SherpaPharma is an innovative software solution for managing the environmental monitoring process in pharmaceutical companies.

It improves the quality of the environmental monitoring process and saves you a lot of time by generating environmental monitoring reports instantly.

-Your production areas and departments can be configured in the system together with clean rooms, sampling points, etc., even independent production plants for the same company.  

-The system accepts the following types of samples: air (settle plates and dynamic sampling), surfaces, water, personnel, products (starting materials, intermediate products, and finished products).

-The system tracks every plate, linking it to the point and the operator responsible for each sample. When receiving plates in the lab, the software tracks the correct incubation process, reading of results and identification. Alerts are generated if results are higher than limits. Plates are easily read using a cleanroom-compatible barcode reading device.

-SherpaPharma uses a mobile app running on a mobile device to track any actions carried out on plates or other media. Keep track of every sample from the moment it is taken to incubation and reading. Use the PC application to plan your samples, track the whole process, and analyse your results.

-The software has been designed with data integrity requirements in mind as well as for full compliance with FDA CFR21 Part 11 and EU GMP Annex 11. From the moment data is entered into the system, any modification will be fully tracked through a filterable audit trail.

SherpaPharma has three variants of licenses, paid annually and applies per plant.
All three licenses have unlimited number of users, the difference is in the number of sampling points.
-Mini: Up to 100 sampling points.
-Medium: Up to 500 sampling points.
-Max: Unlimited sampling points.


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SherpaPharma Licens Year 1 Cloud Mini (100)
SHP-001

Mini, start licens year 1, up to 100 sampling points.

 

Conditions:

- 1 manufacturing plant.

- Up to 100 sampling points.

- Unlimited number of users.

 

The fee includes:

- License to access SherpaPharma for 12 months.

- Start-up training.

- Release and validation of new versions during 12 months.

- Working hours support (from 9 to 17h CET). first level response in less than 24h (working days).

- Urgent substitution of devices in case of failure.

 

Pdf SherpaPharma

 

PDF SherpaPharma and how it works

 

SherpaPharma Licens Annual Cloud Mini (100)
SHP-001C

Mini, annual licens, up to 100 sampling points.
(From year 2 and forward)

 

Conditions:

- 1 manufacturing plant.

- Up to 100 sampling points.

- Unlimited number of users.

 

The fee includes:

- License to access SherpaPharma for 12 months.

- Release and validation of new versions during 12 months.

- Working hours support (from 9 to 17h CET). first level response in less than 24h (working days).

- Urgent substitution of devices in case of failure.

 

PDF SherpaPharma

 

PDF SherpaPharma and how it works

 

SherpaPharma Licens Year 1 Cloud Medium (500)
SHP-002

Medium, start licens year 1, up to 500 sampling points.

 

Conditions:

- 1 manufacturing plant.

- Up to 500 sampling points.

- Unlimited number of users.

 

The fee includes:

- License to access SherpaPharma for 12 months.

- Start-up training.

- Release and validation of new versions during 12 months.

- Working hours support (from 9 to 17h CET). first level response in less than 24h (working days).

- Urgent substitution of devices in case of failure.

 

PDF SherpaPharma

 

PDF SherpaPharma and how it works

 

SherpaPharma Licens Annual Cloud Medium (500)
SHP-002C

Medium, annual licens, up to 500 sampling points.

 (From year 2 and forward)

 

Conditions:

- 1 manufacturing plant.

- Up to 500 sampling points.

- Unlimited number of users.

 

The fee includes:

- License to access SherpaPharma for 12 months.

- Release and validation of new versions during 12 months.

- Working hours support (from 9 to 17h CET). first level response in less than 24h (working days).

- Urgent substitution of devices in case of failure.

 

PDF SherpaPharma

 

PDF SherpaPharma and how it works

 

SherpaPharma Licens Year 1 Cloud Max (unlimited)
SHP-003

Max, start licens year 1, unlimited sampling points.

 

Conditions:

- 1 manufacturing plant.

- Unlimited sampling points.

- Unlimited number of users.

 

The fee includes:

- License to access SherpaPharma for 12 months.

- Start-up training.

- Release and validation of new versions during 12 months.

- Working hours support (from 9 to 17h CET). first level response in less than 24h (working days).

- Urgent substitution of devices in case of failure.

 

PDF SherpaPharma

 

PDF SherpaPharma and how it works

 

SherpaPharma Licens Annual Cloud Max (unlimited)
SHP-003C

Max, annual licens, unlimited sampling points.

 (From year 2 and forward)

 

Conditions:

- 1 manufacturing plant.

- Unlimited sampling points.

- Unlimited number of users.

 

The fee includes:

- License to access SherpaPharma for 12 months.

- Release and validation of new versions during 12 months.

- Working hours support (from 9 to 17h CET). first level response in less than 24h (working days).

- Urgent substitution of devices in case of failure.

 

PDF SherpaPharma

 

PDF SherpaPharma and how it works

 

Executed standard SherpaPharma validation documentation (GAMP 5)
SHP-DOC-VAL

Executed Standard SherpaPharma validation.
(Year 1)

 

Documentation includes: 

- Validation Plan

- User Requirements Specifications

- Functional Specification

- Configuration and Design Specifications

- Risk Analysis

- Installation Qualification Protocol

- Operational Qualifiaction Protocol

- Validation Report- Traceability Matrix

Wi-Fi barcode reader NFC device for SherpaPharma.
SHP-TC51-HC

WiFi barcode reader NFC device.

 

Including:

 

- License to use SherpaPharma mobile application.

- Application installation and device activation in the client environment.

- Device Zebra TC51-HC WiFi 2D CAM ANDROID IP67* Portable data collection device, healthcare, 2D imager, Cam (13MP, auto-focus), Push to talk, 12.7 cm (5''),   Bluetooth (class 4.1), Wi-Fi (802.11ac), NFC, Micro SD-Slot (max. 32GB),   1280x720 pixels, 1.8 GHz, Android (6.0), IP67 *.

- Dock/charger Zebra TC51 1-Slot USB Healthcare.  Includes power supply and micro-USB.

- 3 years maintenance including repairs.

 

 

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