VMP,MVP etc

COMPUTER SYSTEM VALIDATION (CSV) SOFTWARE VALIDATION DOCUMENTATION
1

I have come across words such as Validation Master Plan, Master Validation Plan and Validation Plan.

Are these documents different or is it the same document with different names. Can anyone let me know what these different words mean?

2

Hi,

There is no difference between Master Validation lan and Validation Master Plan.

Check the link below to find the difference between Master Validation Plan and Validation Plan.

http://www.askaboutvalidation.com/forum/showthread.php?t=266

3

Could it be possible to have two validation plans if validation is being carried out in two phases (One for each phase).

4

Yes there is no definite answer each company has their oown way of creating plans.

Personally I would have two MVP and then in that include a section for phase 1 validation and phase 2 validation.

Regards

5

As stated, it’s a personal / company preference.

I would choose to write only 1 MVP and allow for phase-specific plans that are subordinate to the MVP. We’ve done this with a client where we rolled up all the validation activities into a ‘generic’ MVP and then wrote subordinate plans for phases, projects, categories, etc.

This allows the “Master” document to be stable while the subordinate docs are developed at the time and detail needed.

6

[quote=yodon]As stated, it’s a personal / company preference.

I would choose to write only 1 MVP and allow for phase-specific plans that are subordinate to the MVP. We’ve done this with a client where we rolled up all the validation activities into a ‘generic’ MVP and then wrote subordinate plans for phases, projects, categories, etc.

This allows the “Master” document to be stable while the subordinate docs are developed at the time and detail needed.[/quote]

Yes, Mr Graham is right “each company has their own way of creating plans”. Its depends on company policies, but in my opinion there should one Validation Master Plan for every year, it should be a live document, which includes centralized document system, project task time lines with their tracking and validation master schedule and many other items and it should be revised according the completion of the tasks that’s why this document said live document, but if there is any separate project would start then it may suitable for create VMP for specific project.

Thanks