Purpose & Scope (Including identification of the process/product/system/hardware/software under validation and reference to the V&V plan/strategy to be satisfied)
Summary of V&V activities & Deviations (Summarizes the V&V activities performed and identifies any deviations from V&V plan/strategy)
Summary of V&V results (Summarizes the outcome of the V&V activities performed, including reference to V&V reports that detail the V&V results)
Discussion & Acceptance (Discusses the validation and acceptance status)
Conclusion (States the readiness for release)
Validation Lead Signature (Establishes the signature holder’s confirmation that 1. the content of this report is adequate and 2. he/she takes full ownership of the stated conclusion in this report)
Hi,
normally, the report should be part of the main document (val. or qual. protocol), but, can be separated, also.
If you put separated report from main doc, the advance is, for example, that you shown to inspector only report, not all protocol. …OK…this is my opinion:)
The bad point is that you need to generate another one No and put report under change control, also. This mean…increasing of documentation.
Can someboddy explaine me the next situation and advice me what is correct to do…
For example…tablet machine. This machine was qualified and in the normal work condition for five years. After that was changed computer unit within SW inside. What you will do??
Qualify again full system??
Only computer part of system???
What will happen with old protocol???
Generate new protocol or only part of old one???
Generate a new one report???
For example…tablet machine. This machine was qualified and in the normal work condition for five years. After that was changed computer unit within SW inside. What you will do??
Could you clear up this one point please, was an existing computer changed for a new one of the same format (like for like) or is this a new addition to a 5 year old machine?
for me,you can attach one addendum to your old report,when only a supporting unit is changed (as you say ,like for like).But when this unit alters the whole operational unit and having direct effect on quality of product, you should go for complete validation.As for example,FBD(Make:Alliance) converted to FBP,by providing top spray option for palletization,go for complete qualification.However this is only my openion
for me,you can attach one addendum to your old report,when only a supporting unit is changed (as you say ,like for like).But when this unit alters the whole operational unit and having direct effect on quality of product, you should go for complete validation.As for example,FBD(Make:Alliance) converted to FBP,by providing top spray option for palletization,go for complete qualification.However this is only my openion.
regards,
dianamo