Computerised system Validation Flashcards
Which guideline are used for the CSV?
Linked Guidline EDQM and PIC/S
Linked Guideline EDQM defines?
basic principles for the validation of computerised systems
which laboratories are used for the computerized system?
Official Medicines Control Laboratories
what is the purpose of the validation (EDQM)
it is to guarntee confidence in the laboratory ata captured, processes, reported or stored by computerized systems
what is the purpose linked Guidline PIC/S
this document is used to provide recommendations and background information
Which information are provide (PIC/S)
information concering computerized system that will be of assistance to inspectors (e.g traning purposes)
What are computerised system?
A computer system that includes software, hardware, connected to a laboratory equipment
Categorisation of compuerised systems are?
Exempted, simple and complex
Category: Exempted:
No calibration function (e. g Calculate or opearting ystem)
No action needed
Category: Simple
Small part of software or restriced customisation (pH meter, TLC anayser, AAS
Action: simplified validation such as calibration and function control test
Category: complex
Exteded amount of functionality (extened customisation (LIMS) Validation needed
when should computerised system should be validated?
if calibration alone is not sufficient to prove the functionality and reliability of the system
Was is the definition and purpose of CSV?
it is a documented process of assuring that a computerized system does exactly what it is designed to do
Why do we need a risk managment?
the RM throughout the whole life cycle of a sytsme shall enure patients safety, data integrity and prodcut quality
How can you describe the life-cycle of a CSV?
V-Model
what are the specification of the CSV?
User requirement specification, Funtional specification, technical design and development
what are the test phases
Unit module, integration test, functional testing and requirement testing
what is a user requirement?
any need or expectation for a system or for its software
what does the requirements reflects?
the steted or implied needs of the customer.
example for a process-related requirement is
only authorized users are justiied to get the access right to a system
example for a function-related requirement is
the system has to have a passoword protection
what are the Detailed user requirements?
Graphical user interfaces
Data interface
runtime enviroment
what is a functional specifications?
a document that states requirements
what is Technical design and development?
Explanation for computer programmer, how to translate the functional specifications and specifying also the required hardware
Unit Modul test is?
Verification, where the modul runs or not
which tool can be used in the unit modul test?
White-box-Tesing
defintion: White-box-Tesing
testing the application at the level of the source code
which code coverage criteria have to be considered?
Control flow testing, Data flow testing, Branch testing
Why do we used the unit modul test?
to minimize erroe and create an error-free environment
integration, functional and requiremnet testing
where ne check if technical design has been fulfilled: if units are suitable to provide reliable interaction
Where is the validation plan in the V-model
right at the beginning (Userr requirements) it is important to set it right
Which parameters are used to describe the software development lifecycle
Quality system and life cycle documentation
What belonges to the quality system?
Q-system, Training, Security, Supplie and Change Management (decreased risk assessment)
Which parameter are part of the LCD?
DQ, IQ, OP, PQ
Which elements belongs to DQ?
URS, System specification (technical and functional)
what belonges to IQ?
Technical design, Unit specification, programming, unit test and integration test
what belonges to OQ?
System Test
what belonges to PQ?
User Acceptance Test
Draw the expanded V-model of the software development lifecycle
Do you know it?
IQ is define as?
To demonstrate that the system has been properly installed in the user’s environment
OQ is define as?
to demonstrate that all functions needed for the intended purpose are avaiable and operate reliably in the user’enviroment
PQ is define as?
to demonstate that a computersized system is suitable for its intended purpose as defined in the URA
what does qualification means?
Formal testint to demonstrate that the software meets ots specified requirements
on what is a software developed?
on standard-release products
how is the system validation defind?
it is only valid for one or the other configuration
Why are good practices important when setting a new speadsheet
they will educe the risk of accidental modification of the template and erroneous data input
How is the regular verification of the spreadsheet carry out?
after ach change in the soft or hardwarre configuration, verification takes place.
To ensure that validated state is maintained
how the verification registered?
Date of operation, intervention, comments, operator’s signature
What are the Good Automated Manufacturing Practice software Categories?
Cat.1 the least risk and most widely avaiable software (operating systems
Cat 2: Firmware
Cat 3: standard software packages
Cat 4: Configurable softwae packages
Cat 5: Custom Software: developed to meed the specific needs of the user company
Cat 5 is
a unique solution that is conceived specified, written, tested and maintained by the users or the organization
Classification of software on medical device (first)
- software intended to be used for one or moore medical purposes thhat perform these purposes without being part of a heardware medical device
Classification of software on medical device (second)
software that is intended to be used, alone or in combination for a purpose as specified in the definition of a medical device in the demcal devices regulation or in vitro daignostic medical devices regulation
on hwat does the classification of software as medcial device depends on?
on its intended by, which is defind by the manufacturer. it is used for diagonsis, therapy or monitoring odiseases
Which guideline covered the validation of medical device software
Linked guideline FDA