Validation workshop

Validation planning is a regulatory requirement according to?

• annex 2

• annex 15

• paragraph 56

• annex 111

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.

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

PQMP is used for

• Minor projects

• Deviations in novoGlow

• As a part of the DCC flow in Qualitydocs

• Large complex projects

Is it allowed to use the change request for planning?

• yes

• no

• sometimes

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.

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

What is the validation planning report used for?

• Document deviations

• Document audit findings

• System/process is validated, fit for intended use and ready for release

The purpose for requirement setting is to specify

• Number of deviations

• How many coffee breaks during validation activities

• The needed requirements, Fit for intended use

• Design specification

You define your critical aspects during?

• Identify requirements

• Assess requirements

• Approve requirements

• FAT/SAT