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ולידציה -Testing and HW/SW Type and Maturity

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ולידציה -Testing and HW/SW Type and Maturity – GAMP

Process automation systems generally comprise several elements. Categorizing these elements according to those described in GAMP 4 can assist in targeting testing and validation effort.

Some functional elements may be fully contained within the system standard packages or firmware (FW), while others may require different degrees of configuration or customization. In general, the greater the degree of customization, the greater the scope of testing required.

For example, if an item of the process equipment is to be controlled, the User may have several options for implementing the process control system functional element.

:Typical Test Phases for Process Automation Systems

Complex control exists as single, mature 'equipment level' library module, where functions can be selected/ deselected and  setup parameters entered

For example, sterilizer module with selectable cycle types

Application Life Cycle Testing: selection of functions, setup parameters

:Typical Test Phases

FAT and /or

SAT

IQ/OQ/PQ of process equipment

Complex control built up from mature, interlinked 'device level' library modules, which must have correct parameters entered

For example, sterilizer control, built up from valve, motor, PID, set-point program modules.

Application Life Cycle Testing: selection and linking of modules functions to give correct functionality, setup parameters

:Typical Test Phases

FAT

SAT

IQ/OQ/PQ of process equipment

Complex control built up from application specific modules, themselves built up from low-level library modules, or from simple coded steps within a predefined structure.

For example, sterilizer control configured in ladder logic

Application Life Cycle Testing: functionality of custom coded modules, selection and linking of modules functions to give correct functionality, setup parameters

:Typical Test Phases

Module test

FAT

SAT

IQ/OQ/PQ of process equipment

Complex control custom added

For example, sterilizer control coded in C++

Application Life Cycle Testing: functionality of custom coded modules, interaction between custom coded modules, selection and linking of modules functions to give correct functionality,setup parameters.

:Typical Test Phases

Module test

Module integration test

FAT

SAT

IQ/OQ/PQ of process equipment

:Notes

The suggested test phases listed above are typical only; they may be increased or decreased to reflect the complexity of the application, and the impact on product quality, patient safety and data integrity

The above assumes mature, 'industry proven' library modules. If these are created specifically for the application, then they need to be treated as custom code

Smartlogic expertise in validation of current and new systems to meet the most rigid requirements of the FDA and CFR protocols.

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

ולידציה – Installation Qualification (IQ) Protocol – 2

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Installation Qualification (IQ) Protocol

Preparation Overview – part 2

 Installation Qualification (IQ) Protocol –  Test Procedures

This chapter contains all the test procedures or verifications required to verify the system under validation is properly installed and can be properly operated according to the supplier's requirements and user's specifications.

Each test procedure or verification must include the same contents:

Purpose or Objective

Procedure or Method

Acceptance Criteria

Test Results

The next sections provide overviews of the main test procedures and verifications, and their purposes. This IQ procedure is generic, and relevance of the test procedures and verifications provided below depends on the composition of the system under validation.

Note:

As mentioned in the previous chapter on IQ Protocol Contents, the final contents of the IQ protocol are tailored according to the type and size of the system under validation. Since this document is generic, it covers test procedures that may not be necessary in small or simple systems.

Drawings Verification

This procedure is intended to obtain signed, updated copy of the user's Piping and Instrumentation Drawing (P&ID), and verify that the drawing is accurate.

 Site Preparations

This procedure is intended to verify that the system under validation is installed and operated under environmental conditions, in particular temperature conditions, which comply with the manufacturer’s requirements.

                          Hardware Installation Test Procedures

  Voltage Supply

This procedure is intended to verify that the voltage supplied to the system components complies with the design requirements.

 IO List

This procedure is intended to verify that the system components are identified and installed in compliance with the IO List, the P&ID, and the system hardware requirements.

                        Software Installation Test Procedures

This section describes the test procedures for the installation of purchased software (SW) and application SW. These test procedures are relevant when the supplier installs these SW systems.

Supplier Installed Software

This procedure is intended to verify that purchased SW installed in the supervisory computer and control system (where relevant) by the supplier complies with the SW design requirements.

 Other Purchased Software

This procedure is intended to verify that other purchased SW, such as a version of Windows, is correctly installed on the system.

  Application Software

This procedure is intended to verify that the custom application SW is installed according to the design requirements.

 Closed System Verification (Where Relevant)

This procedure is intended to verify that the system is closed, i.e., it cannot communicate with Internet networks.

Glossary

CFR Code of Federal Regulations
FDA Food and Drug Administration
FRS Functional Requirements Specification
HW Hardware
IQ Installation Qualification
OQ Operational Qualification
QA Quality Assurance
SSO Schedule of System Operation
SW Software
URS User Requirements Specification

ולידציה – GAMP – Hardware & Software Test Environments

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ולידציה –  GAMP – Hardware & Software  Test Environments

Good Automated Manufacturing Practice (GAMP) Hardware (HW) Environment Test

HW can be categorized according to both GAMP 4 HW category (standard or custom) and its function within the test environment. It can be one o f these three things

 Part of the system under test, i.e., part of the production HW

 Test HW representing part of the production environment, which may be needed because it is not feasible to include a certain element of the production system in the test environment

A separate test system, which may be used to represent an external system

          Representative Test Environment

As started previously, the HW environment should represent as close as possible the production environment

For example, if the test environment uses a standard network hub of the same type as the production environment, then the substitution probable introduces low probability if invalid test results in the production environment. If, however, the network cabling in the test environment is uses short patch cables, whilst the real environment has cable runs close to the maximum recommended length, there is clearly a possibility of different network behavior, and additional tests on site may be needed to prove proper network performance

                    Control of Test Environment

For standard HW (per GAMP 4 HW Category 1), the manufacturer's reference and serial numbers should be recorded.

For custom HW (per GAMP 4 HW Category 2), the version of the item and its controlling specification should also be recorded.

For all test HW, any applicable calibration status should be recorded in the context of the specific

                         Removal from Production Environment

If the test HW is added in the way that it may appear in the production environment, then, this should be documented a temporary modification to the production system. Removal of the temporary modification should be documented as well

Good Automated Manufacturing Practice (GAMP)  Software (SW) Environment Test

Test SW can also be categorized according to both GAMP 4 SW category and its function within the test environment:

Part of the system under test, i.e., part of the production HW

Test SW representing part of the production environment

A separate test system

              Representative Test Environment

The SW environment should represent as close as possible the production environment

For example, if the test environment uses a process controller of the same type as the production environment, then the substitution probable introduces low probability if invalid test results in the production environment. If, however, a particular interface is simulated in the test environment, a possibility remains that different timing factors or process dynamics could affect the operation in the production environment, and additional tests on the production interface may be appropriate

                        Control of Test Environment

For standard SW (per GAMP 4 SW Category 1, 2 or 3), the manufacturer's reference and version numbers (including installed patch cables) should be recorded. Any configuration or setup parameters should be controlled

For configured or custom SW (per GAMP 4 SW Category 4 or 5), the item should be placed under configuration management and the version in use recorded

              Removal from Production Environment

If the test SW is added in the way that it may appear in the production environment, then, this should be documented a temporary modification to the production system. Removal of the temporary modification should be documented as well

ולידציה –  GAMP – Hardware & Software  Test Environments