Computerised system Validation

Question 1

Which guideline are used for the CSV?

Answer 1

Linked Guidline EDQM and PIC/S

Question 2

Linked Guideline EDQM defines?

Answer 2

basic principles for the validation of computerised systems

Question 3

which laboratories are used for the computerized system?

Answer 3

Official Medicines Control Laboratories

Question 4

what is the purpose of the validation (EDQM)

Answer 4

it is to guarntee confidence in the laboratory ata captured, processes, reported or stored by computerized systems

Question 5

what is the purpose linked Guidline PIC/S

Answer 5

this document is used to provide recommendations and background information

Question 6

Which information are provide (PIC/S)

Answer 6

information concering computerized system that will be of assistance to inspectors (e.g traning purposes)

Question 7

What are computerised system?

Answer 7

A computer system that includes software, hardware, connected to a laboratory equipment

Question 8

Categorisation of compuerised systems are?

Answer 8

Exempted, simple and complex

Question 9

Category: Exempted:

Answer 9

No calibration function (e. g Calculate or opearting ystem)

No action needed

Question 10

Category: Simple

Answer 10

Small part of software or restriced customisation (pH meter, TLC anayser, AAS
Action: simplified validation such as calibration and function control test

Question 11

Category: complex

Answer 11

Exteded amount of functionality (extened customisation (LIMS) Validation needed

Question 12

when should computerised system should be validated?

Answer 12

if calibration alone is not sufficient to prove the functionality and reliability of the system

Question 13

Was is the definition and purpose of CSV?

Answer 13

it is a documented process of assuring that a computerized system does exactly what it is designed to do

Question 14

Why do we need a risk managment?

Answer 14

the RM throughout the whole life cycle of a sytsme shall enure patients safety, data integrity and prodcut quality

Question 15

How can you describe the life-cycle of a CSV?

Answer 15

V-Model

Question 16

what are the specification of the CSV?

Answer 16

User requirement specification, Funtional specification, technical design and development

Question 17

what are the test phases

Answer 17

Unit module, integration test, functional testing and requirement testing

Question 18

what is a user requirement?

Answer 18

any need or expectation for a system or for its software

Question 19

what does the requirements reflects?

Answer 19

the steted or implied needs of the customer.

Question 20

example for a process-related requirement is

Answer 20

only authorized users are justiied to get the access right to a system

Question 21

example for a function-related requirement is

Answer 21

the system has to have a passoword protection

Question 22

what are the Detailed user requirements?

Answer 22

Graphical user interfaces
Data interface
runtime enviroment

Question 23

what is a functional specifications?

Answer 23

a document that states requirements

Question 24

what is Technical design and development?

Answer 24

Explanation for computer programmer, how to translate the functional specifications and specifying also the required hardware

Question 25

Unit Modul test is?

Answer 25

Verification, where the modul runs or not

Question 26

which tool can be used in the unit modul test?

Answer 26

White-box-Tesing

Question 27

defintion: White-box-Tesing

Answer 27

testing the application at the level of the source code

Question 28

which code coverage criteria have to be considered?

Answer 28

Control flow testing, Data flow testing, Branch testing

Question 29

Why do we used the unit modul test?

Answer 29

to minimize erroe and create an error-free environment

Question 30

integration, functional and requiremnet testing

Answer 30

where ne check if technical design has been fulfilled: if units are suitable to provide reliable interaction

Question 31

Where is the validation plan in the V-model

Answer 31

right at the beginning (Userr requirements) it is important to set it right

Question 32

Which parameters are used to describe the software development lifecycle

Answer 32

Quality system and life cycle documentation

Question 33

What belonges to the quality system?

Answer 33

Q-system, Training, Security, Supplie and Change Management (decreased risk assessment)

Question 34

Which parameter are part of the LCD?

Answer 34

DQ, IQ, OP, PQ

Question 35

Which elements belongs to DQ?

Answer 35

URS, System specification (technical and functional)

Question 36

what belonges to IQ?

Answer 36

Technical design, Unit specification, programming, unit test and integration test

Question 37

what belonges to OQ?

Answer 37

System Test

Question 38

what belonges to PQ?

Answer 38

User Acceptance Test

Question 39

Draw the expanded V-model of the software development lifecycle

Answer 39

Do you know it?

Question 40

IQ is define as?

Answer 40

To demonstrate that the system has been properly installed in the user's environment

Question 41

OQ is define as?

Answer 41

to demonstrate that all functions needed for the intended purpose are avaiable and operate reliably in the user'enviroment

Question 42

PQ is define as?

Answer 42

to demonstate that a computersized system is suitable for its intended purpose as defined in the URA

Question 43

what does qualification means?

Answer 43

Formal testint to demonstrate that the software meets ots specified requirements

Question 44

on what is a software developed?

Answer 44

on standard-release products

Question 45

how is the system validation defind?

Answer 45

it is only valid for one or the other configuration

Question 46

Why are good practices important when setting a new speadsheet

Answer 46

they will educe the risk of accidental modification of the template and erroneous data input

Question 47

How is the regular verification of the spreadsheet carry out?

Answer 47

after ach change in the soft or hardwarre configuration, verification takes place. To ensure that validated state is maintained

Question 48

how the verification registered?

Answer 48

Date of operation, intervention, comments, operator's signature

Question 49

What are the Good Automated Manufacturing Practice software Categories?

Answer 49

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

Question 50

Cat 5 is

Answer 50

a unique solution that is conceived specified, written, tested and maintained by the users or the organization

Question 51

Classification of software on medical device (first)

Answer 51

1. software intended to be used for one or moore medical purposes thhat perform these purposes without being part of a heardware medical device

Question 52

Classification of software on medical device (second)

Answer 52

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

Question 53

on hwat does the classification of software as medcial device depends on?

Answer 53

on its intended by, which is defind by the manufacturer. it is used for diagonsis, therapy or monitoring odiseases

Question 54

Which guideline covered the validation of medical device software

Answer 54

Linked guideline FDA