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Quality Managment > Computerised system Validation > Flashcards

Computerised system Validation Flashcards

1
Q

Which guideline are used for the CSV?

A

Linked Guidline EDQM and PIC/S

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2
Q

Linked Guideline EDQM defines?

A

basic principles for the validation of computerised systems

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3
Q

which laboratories are used for the computerized system?

A

Official Medicines Control Laboratories

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4
Q

what is the purpose of the validation (EDQM)

A

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

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5
Q

what is the purpose linked Guidline PIC/S

A

this document is used to provide recommendations and background information

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6
Q

Which information are provide (PIC/S)

A

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

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7
Q

What are computerised system?

A

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

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8
Q

Categorisation of compuerised systems are?

A

Exempted, simple and complex

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9
Q

Category: Exempted:

A

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

No action needed

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10
Q

Category: Simple

A

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

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11
Q

Category: complex

A

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

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12
Q

when should computerised system should be validated?

A

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

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13
Q

Was is the definition and purpose of CSV?

A

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

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14
Q

Why do we need a risk managment?

A

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

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15
Q

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

A

V-Model

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16
Q

what are the specification of the CSV?

A

User requirement specification, Funtional specification, technical design and development

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17
Q

what are the test phases

A

Unit module, integration test, functional testing and requirement testing

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18
Q

what is a user requirement?

A

any need or expectation for a system or for its software

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19
Q

what does the requirements reflects?

A

the steted or implied needs of the customer.

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20
Q

example for a process-related requirement is

A

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

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21
Q

example for a function-related requirement is

A

the system has to have a passoword protection

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22
Q

what are the Detailed user requirements?

A

Graphical user interfaces
Data interface
runtime enviroment

23
Q

what is a functional specifications?

A

a document that states requirements

24
Q

what is Technical design and development?

A

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

25
Q

Unit Modul test is?

A

Verification, where the modul runs or not

26
Q

which tool can be used in the unit modul test?

A

White-box-Tesing

27
Q

defintion: White-box-Tesing

A

testing the application at the level of the source code

28
Q

which code coverage criteria have to be considered?

A

Control flow testing, Data flow testing, Branch testing

29
Q

Why do we used the unit modul test?

A

to minimize erroe and create an error-free environment

30
Q

integration, functional and requiremnet testing

A

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

31
Q

Where is the validation plan in the V-model

A

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

32
Q

Which parameters are used to describe the software development lifecycle

A

Quality system and life cycle documentation

33
Q

What belonges to the quality system?

A

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

34
Q

Which parameter are part of the LCD?

A

DQ, IQ, OP, PQ

35
Q

Which elements belongs to DQ?

A

URS, System specification (technical and functional)

36
Q

what belonges to IQ?

A

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

37
Q

what belonges to OQ?

A

System Test

38
Q

what belonges to PQ?

A

User Acceptance Test

39
Q

Draw the expanded V-model of the software development lifecycle

A

Do you know it?

40
Q

IQ is define as?

A

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

41
Q

OQ is define as?

A

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

42
Q

PQ is define as?

A

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

43
Q

what does qualification means?

A

Formal testint to demonstrate that the software meets ots specified requirements

44
Q

on what is a software developed?

A

on standard-release products

45
Q

how is the system validation defind?

A

it is only valid for one or the other configuration

46
Q

Why are good practices important when setting a new speadsheet

A

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

47
Q

How is the regular verification of the spreadsheet carry out?

A

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

48
Q

how the verification registered?

A

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

49
Q

What are the Good Automated Manufacturing Practice software Categories?

A

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

50
Q

Cat 5 is

A

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

51
Q

Classification of software on medical device (first)

A
  1. software intended to be used for one or moore medical purposes thhat perform these purposes without being part of a heardware medical device
52
Q

Classification of software on medical device (second)

A

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

53
Q

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

A

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

54
Q

Which guideline covered the validation of medical device software

A

Linked guideline FDA

Quality Managment (8 decks)

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