3 replies to this topic

[walt1908]

Can an internal audit also be used as 2.5.1 validation vice versa? So I'll do my annual validation for logs and program each month but can that also count as an internal audit 2.5.4? the internal audit and validation would have the same date is that possible ? Trying to see if I can knock two birds with one stone. 

[Scotty_SQF]

So I have found out that depends on the auditor.  I have used Internal audits as a validation and been called out that that wasn't enough by an auditor.  Basically I could use it but needed to have documented metrics and show the metrics were being met.  Just for the following year a different auditor telling me I went above and beyond as internal audits were good enough for our facility.  So I use internal audits and have created validation sheets that have metrics and every year use those sheet to show that the findings of the internal audits meet the metrics and thus validated.  Just to cover my basis.

[walt1908]

So I have found out that depends on the auditor.  I have used Internal audits as a validation and been called out that that wasn't enough by an auditor.  Basically I could use it but needed to have documented metrics and show the metrics were being met.  Just for the following year a different auditor telling me I went above and beyond as internal audits were good enough for our facility.  So I use internal audits and have created validation sheets that have metrics and every year use those sheet to show that the findings of the internal audits meet the metrics and thus validated.  Just to cover my basis.

Thank you so much that makes sense, do you have like an example sheet of the validation you use?

[kingstudruler1]

Yes, IMO internal audits and third party audits can be source of validation far "applicable elements"  as stated in 2.5.1.

 

Depending on what your validation procedure is for "logs and Programs"  there could also be overlap with the internal audit as well.