Features of the Ph21 R4.5-5 Software System
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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)
- Mettler Toledo balance with MT-SICS interface
- Sartorius balance with SBI interface
- Dr. Schleuniger 5Y, 6D, 8M and HS-8 banchtop hardness testers
- Mitutoyo calipers and gauges with DIGIMATIC interface
(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:
- Online Date Transfer (ODT)
- Batch Export Functions
- LIMS Integration option
- Ph21 Systems using a centralized Database
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
