DataPro 2.5e

Applications

Designed for biopharmaceutical and other regulated organizations that do not have a Laboratory Information Management System (LIMS). DataPro 2.5e is an ideal solution for those seeking to deploy an affordable high-reliability secure Facility Monitoring System (FMS) for their Climet Portable Particle Counters. DataPro 2.5e satisfies all requirements of FDA 21 CFR Part 11.

Secure Exporting of Data

A particle counter's sample data can be securely exported directly into the DataPro SQL database via RS-232, Ethernet, Wi-Fi, or USB stick.

Every Climet particle counter has an RS-232   port that can be connected to a computer or laptop's serial port, or through the use of a RS-232-to-USB adapter (p/n: 77308100).  Importing data directly into DataPro's SQL database is easily accomplished with a simple click of a mouse button.

 

When connected via Ethernet or Wi-Fi, sample data is pushed directly into the SQL database by the particle counter by simply pressing "Confirm" (See below):

Sample data can also be extracted from a portable particle counter through its USB port onto a USB flash drive.  After the sample data has been imported onto the computer system, Climet's USB Translator Utility will validate each sample data file, and upload the files onto a secure network directory. It is recommended that this task be the responsibility of a System Administrator. 

Sample Data Validation & Protection

Sample data files are directly imported from the particle counter directly into DataPro's SQL database.  As part of the import process, each individual sample data file is authenticated to ensure sample data has not been corrupted.  Moreover, the sample data files themselves are secured with a MD5 128-bit hash.

User Integrity

During the setup of DataPro 2.5e, username and passwords are assigned, as well as security levels (Level 1-4).

Navigation is made user friendly with tabs, and access is restricted depending on assigned security levels. Level 1 has all access of levels 2-4, plus administrative permissions to add/delete/change.  Level 4 can only view alarms and has access to the dashboard.   

Sample Data Integrity

DataPro 2.5e verifies data integrity by ensuring sample data has not been manipulated or rows in the database deleted.

Reporting

TBD

Analytics and Trending 

Tbd

Continuous Monitoring Features

Scheduling and remote sampling are features for those using portable particle counters  Leverage investment

iMapping

Upload a floor plan drawing, and place monitoring

View Alarms / Comments

TBD

Audit Subsystem

TBD