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Joshua Rask
We recently had a surveillance audit, and the auditor wrote a finding for missing gauges. The gauges that were ...

I am only speculating, but are the extra set of thread anvils of the same type used as a control and ensuring the ...

Jerri Alexander
We exclude Clause 8.3 in our QM and Scope however we do have a Quality Procedure titled: 830 Process Design and ...

Not that exact one, but know that your registrar’s opinion on what you should name procedures is just that - an ...

Brandy Vanbuskirk
We are a GMP facility that follows 21CFR 210 & 211. At what frequency do you temperature map your critical ...

Brandy,

Annual calibration and performance verification seems to be a logical and adequate cycle time for ...

Guiomar Meaders
Hello everyone, I need to create a project plan to move everything in our current QMS to an e-QMS, Qt9. This is my ...
Guiomar Meaders Dec '21

I am no expert on eQMS but have created a couple of electronic QMS in SharePoint, so assuming you are starting with a ...

We have had QT9 for a couple of years. Anything I can help you with let me know

Hi there, Were you able to find a template for it? I need to do the same for another eQMS and can use your help, if ...

James Hendrickx
Hello all, I am looking for the best method for CIP cleaning validation. I work in a non cGMP facility and we are ...
James Hendrickx Feb '22
Ben Osburn
Hello. We recently just ran a Gage R&R on one of our new pieces of equipment and our R&R and our Variation ...
Ben Osburn Dec '21

The detailed result of the R&R study can help to identify what is wrong with the measurement system. after that ...

Amy Oiler
I am starting a review for a new ISO auditor for a manufacturing company. Can anyone offer insight into ...
Amy Oiler Nov '21

Hi Amy,

Even for internal audits and your supplier audits, always seek auditors with credentials and experience. ...

Hi Amy,

Great response from Donald. I answered this question in the Expert Answer column few years ago. Here is the ...

Seok Tong Lai
Hi all, Wish to get help from here. I am trying to interpret the ISO 9022-12 contamination. I have no idea how does it ...
Seok Tong Lai Nov '21
Guiomar Meaders
Hello, Has anyone heard of the mandatory flow down requirement for covid-19 for federal contractors and ...
Guiomar Meaders Oct '21
Guiomar Meaders
Hello Everyone, First of all, thank you to everyone for all the answers and feedback to my questions. Here is ...
Guiomar Meaders Oct '21