Features of the Ph21 R4.5-5 Software System

Preface

General Functions

The Batch Management System

The Product Catalog

Test Standards

Access Control (Signing On)

Managing Operator Accounts

The Archive Functions

System Configuration (System Setup)

The Universal Tablet Tester Application

The 'disi' Tablet Disintegration Tester Application

The Virtual Test Environment (VTE) Application

Connectivity / External Interfaces of the Ph21 System

Tins &Whistles

Software Development & Software Validation

 

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Preface

More than Ph21 1000 licenses have been issued since 1993. From these, 750 licenses of the software revision 4 have been shipped until March 2010 to major pharmaceutical corporations worldwide.

Therefore with some confidence the Ph21 software system can be regarded as an COTS (commercial, off-the-shelf) product. It can be run straight after setup from CD. There is no enduser-specific configuration work required. From the GAMP point of view this software is to be regarded as a 'Non-Configured Product according to GAMP Category 3'. Therefore the supplier involvement for an purchase of the software is ...'limited to the provision of documentation, training, support ans maintenance'.

General Functions

The Batch Management System

In Ph21 terms a 'batch' is an electronic record which contains test results (measured or manually entered data) of a designated production quantity (i.e. a 'batch'). Active batches are data records which are ready to receive new test results or for which reports can be printed. In-active batches are test results where production is completed. Only in-active batches can be filed into a Ph21 archive. When batches are retrieved from archive, they go into the in-active area. If the operator wants to print reports or run tests onto this batch he has to transfer the batch into the active area.

(approx. 5 minutes)

 

The Product Catalog

The product (also called the 'Method') catalog is a collection of test specifications about nominal values, tolernce limits, alarm definitions and test-device specific parameters. A product specification is the base for all tablet testing

(approx. 5 minutes)

 

Test-device specific Product Parameters are defined in the 'Product/Detail' window:

(less than 5 minutes)

 

Test Standards

Ph-Eur

The European Ph-Eur pharmacopoe defines standards (or Methods) for testing the uniformity of tablet weight and for testing disintegration times

(less than 5 minutes)

USP

The U.S. USP pharmacopoe defines (among a lot others) methods and procedures for testing on disintegration times

 

Access Control

Signing On, Signing Off

There is no operation of the Ph21 system possible without signing on on the system. Every Sign On and every Sign Off is logged in the audit trail. Depending on the access rights of the group the operator belongs to, certain features are available or invisible for the operator.

(less than 5 minutes)

 

Managing Operator Accounts

The Ph21 system provides a unique and comprehensive user account and access control system. Any protection scheme from 'relaxed' to 'extra secure' may be customized by the user of the system.

(less than 5 minutes)

 

The Archive Function

filing and retrieving records to/from archive

the autoarchive

 

System Configuration (System Setup)

Main (Ph21 Desktop) Setup

(less than 5 minutes)

 

Test-Device-Specific Setups (Connecting External Devices)

All device-specific connection properties (Com-port numbers, transmission parameters) are defined at this central location. Furthermore also the properties of the acquired values of this device (units, precision limits, display-formats) will be set-up here.

(less than 5 minutes)

 

Report Layouts

Ph21 printed reports can be 'customized' in several ways by creating a user-specific report layout.

(less than 5 minutes)

A Universal Tablet Tester Report Layout

 

The Universal Tablet Tester (UTT) Application

Performing a Tablet Test

(approx. 5 minutes)

 

Time-Triggered Tablet Tests using an Autosampling Device

(less than 5 minutes)

 

The 'disi' Tablet Disintegration Tester Application

Performing a Pharmacopoe-Compliant Tablet Disintegration Test

(approx. 5 minutes)

 

The Virtual Test Environment (VTE) Application

Entry of manually acquired values

A 'virtual test device' is a Ph21 application which provides the ability to enter measured or otherwise acquired values into the Ph21 system. The values are either keyed-in or a external device may be connected via a serial cable.

External Devices

Currently the Ph21 system supports the following types of external devices (this list may be extended)

(approx. 5 minutes)

 

Connectivity / External Interfaces of the Ph21 System

For the purpose of exchanging data between the Ph21 system ans some ither third-party system the Ph21 provides the following options:

 

Tins &Whistles

The Completely Configurable Ph21 Access Control System

For each Windows control element (menu items, entry fields, buttons, checkboxes, listboxes etc.) acces can be granted or refused to a user having a certain restriction level. This way the normal operator may see less items on his Ph21 window than for example a supervisor or a system administrator. This access control system is unique to the Ph21 system and far ahead to most of the usual Windows application programs.

 

Version/Change Control System of Ph21 Electronic Records

For the vital Ph21 electronic records (products, standards, operator accounts) a change control feature is provided. Each time a record is modified, a copy of the previous state of the record is stored. The user of the system may re-construct any previous state of the record by retrieving a previous copy of the record.

(less than 5 minutes)

 

The Ph21 Database

The Ph21 systems stores ALL data in a Microsoft(R) Sql Server (Sql Express) relational database. This even includes all screen texts, button labels - everything viewable.

The Ph21 distribution contains a royalty-free version of the Sql Server 2005 database (Sql Express 2005). This database version is suitable for small and medium size test applications. For large networked test environments the Ph21 system also can make use of a customer supplied Microsoft Sql Server infrastructure.

(less than 5 minutes)

 

Localization / Language Versions

The Ph21 software system is available in English, German and French language, the 'disi' application also in Spanish language. However because all terms and expressions are stored in a database table, any other language can be added by translating the English expressions.

The online-documentation (PDF documents) are only available in English and German language.

Software Development & Software Validation

The Ph21 Software Development - by Examples

The Ph21 System Validation Concept

The Ph21 software validation makes use of a unique feature in order to verify the correctness and realibility of test result data processing. For this purpose Ph21 compliant test devices (universal tablet testers, tablet weighing systems, tablet disintegration testers) got a build-in pseudo-random number generator. If the device is switched to 'validation mode' then the device sends a reproducible stream of data instead of the actual measured values. The Ph21 software makes use of this data stream to verify the correct data processing and statistical test evaluation.

Excerpt from a Ph21 Test Suite

 

(c)Ph21 Services Ltd.(R) August 2010, All Rights Reserved