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ולידציה – GAMP – Test Example – part 2

Posted on by אביב צברי

Good Automated Manufacturing Practice (GAMP) – Test Example

Testing Process Automation Systems

This article cover  the second part of  our  Good Automated Manufacturing Practice (GAMP) test example. This part will cover  the typical test phases for supplier's application SW Module Testing, supplier's Module Integration Testing and the supplier's Integration Testing – cont'd

                     Typical Test Phases

 Typical test phases for a complex process automation system. This example assumes that the system is configured by a Supplier and delivered to site after a FAT. Test system can also be configured by the system integrator or by the User. In this case, the same coverage is required, but the test phasing and location may be different.

The User and Supplier should work together to develop an overall approach to testing that reflects the risk assessment output and ensures adequate test coverage of the functionality, whilst avoiding unnecessary repeated tests.

: Typical Test Phases for Process Automation Systems

 Supplier's Application SW Module Testing –

Done at the Supplier's premises after the module has been placed under configuration control and code reviewed. Before system integration. Module testing generally covers: Module data handling

 Interfaces to other modules

 Operator interfaces

 Module functionality Failure paths and response to fault conditions should be included within the tests

Supplier's Module Integration Testing –

Done at the Supplier's premises.After individual module have been tested and integrated into a single unit.Before full system integration

Module integration testing generally covers: Correct operation of Interfaces between modules

Failure paths and response to fault conditions should be included within the tests

Supplier's Integration Testing –

Done at the Supplier's premises.After module testing, and before the User is invited to witness the FAT

Integration testing generally covers:

 HW

I/O interfaces

Operator interfaces

Interfaces to other equipment

System functionality

Data handling functions

Failure paths and response to fault conditions should be included within the tests

:HW tests typically include

·      Checking system build against approved HW specifications and drawings

·      Recording system components, version numbers (including SW versions) and capacities

·      Checking electrical supplies and grounding

Supplier's Integration Testing (cont'd) –

Checking correct power up of system components

Checking any self test/diagnostic information

Checking correct communication on standard interfaces

:I/O interface tests typically include

Exercising inputs and outputs to check correct configuration of ranges, alarms, etc.

:Operator interface tests typically include

System displays and navigation

Security and access controls

:Tests for interfaces to other equipment typically include

Checks of communications protocol setup

Checks that the required data can be transferred

Checks of actions in case of communications failure

Tests for system functionality typically include:

Monitoring functions

Alarm strategies

Control functions)control modules, equipment modules, procedural control(

Power failure and recovery

Component failure and redundancy

Performance checks

:Tests for system data handling typically include

Operator data entry

Data formatting and quality checks

Checks of calculated values

Checks of recipes

Checks of access to current process data, alarms and events )displays, alarm summaries, etc.(

Checks of access to historical process data, alarms and events )trends, reports, alarm histories, etc.(

Checks of audit trail functionality

Checks of data capacity and retention times

Checks of archive and restore

Checks of provisions for electronic signatures

Checks of disaster recovery procedures

End of  ולידציה – GAMP – Test Example – part 2

 

 

 

 

ולידציה – GAMP – Test Example – part 1

Posted on by אביב צברי

Good Automated Manufacturing Practice (GAMP) – Test Example

Testing Process Automation Systems

This article cover  the first part of  our  Good Automated Manufacturing Practice (GAMP) test example.

                                     Definitions

This section provides brief descriptions of three different types of process control systems.

                  Configurable Equipment

Configurable Equipment is the collective name given to simple configurable instruments/ devices, such as 3-term controllers, check scales, bar code readers, etc. Their functionality depends on that their configuration setup meets the process requirements. The software (SW) components of these systems are typically defined as GAMP SW Category 2.

                    Embedded Systems

Embedded Systems is the collective name for systems with a greater degree of configuration and programmability. Devices such as Integrated Circuits (ICs) with configuration setups and Programmable Logic Controllers (PLCs), which are supplied as an integral part to an item of process equipment, e.g., PLCs controlling a centrifuge or packaging machine, or IC embedded in High Performance Liquid Chromatography (HPLC) systems. Embedded Systems typically contain SW components belonging to multiple GAMP categories.

                 Stand-Alone Systems

Stand-Alone Systems is the collective name for large programmable control systems having distributed functionality across a network, e.g., Distributed Control Systems (DCSs), and Supervisory Control and Data Acquisition (SCADA). They are engineered as an entity to control a complete plant. Stand-Alone Systems typically contain SW components belonging to multiple GAMP categories.

                      Testing and the GAMP Life Cycle 

     Stand-Alone Systems

A process automation system developed for a new application typically requires some or all of the following test phases:

Suppliers Module Testing

Suppliers Module Integration Testing

Suppliers Integration Testing

Factory Acceptance Test (FAT)

Site Acceptance Test (SAT)

Installation Qualification (IQ)

Operation Qualification (OQ)

Performance Qualification (PQ)

The exact combination of testing required for a particular system should reflect its complexity, the maturity of its underlying SW and hardware (HW) elements, and the risk impact on product quality, patient safety and data integrity. Collectively these will determine the risk priority. The phrase 'low risk' should be understood as 'having a low risk priority, as determined by a formal risk assessment'.

Testing of modifications, patches or upgrades should be related to the risk priority of the change. For example, it may be appropriate for parameter changes to be applied directly to the production environment, assuming that the system have been range checked for such parameter.

End of ולידציה – GAMP – Test Example – part 1