
Validation workshop
Quiz
•
Education
•
Professional Development
•
Practice Problem
•
Hard
Shagana Thiyakaran
FREE Resource
Enhance your content in a minute
15 questions
Show all answers
1.
MULTIPLE CHOICE QUESTION
30 sec • 1 pt
Validation planning is a regulatory requirement according to?
annex 2
annex 15
paragraph 56
annex 111
2.
MULTIPLE CHOICE QUESTION
30 sec • 1 pt
Validation activities should be planned to ensure that all aspects of the system or process will be properly?
Planned, designed, verified, and documented.
Designed, presented, build, and documented.
Specified, designed, verified, and validated.
Tollgate 3, Designed, verified and validated.
3.
MULTIPLE CHOICE QUESTION
30 sec • 1 pt
The validation plan should be approved by?
ER, OR, ER and QA
ER, OR and QA
OR, OR, ER and QA
IT responsible, ER and QA
4.
MULTIPLE CHOICE QUESTION
30 sec • 1 pt
PQMP is used for
Minor projects
Deviations in novoGlow
As a part of the DCC flow in Qualitydocs
Large complex projects
5.
MULTIPLE CHOICE QUESTION
30 sec • 1 pt
Is it allowed to use the change request for planning?
yes
no
sometimes
6.
MULTIPLE CHOICE QUESTION
30 sec • 1 pt
To avoid overload of information in the validation plan, the content should only be validation activities, like:
Requirement setting, how to do clinical testing, Supplier handling, Validation strategy and quality oversight.
Requirement setting, how to handle design, how to respond to an audit finding, Validation strategy and quality oversight.
Requirement setting, how to handle design, Supplier handling, Validation strategy and quality oversight.
Requirement setting, how to handle design, Supplier handling, Validation strategy and no need for quality oversight.
7.
MULTIPLE CHOICE QUESTION
30 sec • 1 pt
Which interfaces should you refer to int the validation plan, in order not to duplicate text?
Maintenance and calibration
MOM server and OPC
Äktar and HPLC
Keyboard and mouse
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