Comments for askaboutvalidation.com

Comment on An Easy Way to Validate a SQL Report by chandra

chandra — Mon, 01 Mar 2010 13:27:11 +0000

Thank you Mr Mark, I like this information

Comment on Premier Validation – The Validation Specialists by Kanu Panchal

Kanu Panchal — Tue, 23 Feb 2010 16:07:46 +0000

Dear Mr. Graham,

This has reference to Job ID 28680 regarding.
I have tired to apply for AAV article development.

I am Pharmacist having more than 25 years experience in defining and impelementation of Quality system in Pharmaceuticle industries in India.

I am haiving on hand experience of defining tailor made validation and qualificaiton protocol.

Please convey the detail requried for said job.

With regards,

Kanu Panchal

Comment on An Easy Way to Validate a SQL Report by frank

frank — Tue, 23 Feb 2010 14:02:39 +0000

Nice article Mark – Its amazing how many companies don’t utilise reports its almost as if people are afraid to use them due to the unwanted validation effort!

Comment on Validation of MS Excel Spreadsheets by Dave

Dave — Tue, 23 Feb 2010 10:33:48 +0000

There are numerous add-ons to Excel which provide audit trails and the necessary features to enable 21CFRpart11 compliance. DaCS is probably the most widely used add-on in the Life Sciences arena, details can be found at http://www.spreadsheetvalidation.com

One other consideration when validating spreadsheets is the time/costs required for the documentation/testing. If you have a large (ie more than about 5!) portfolio of GxP critical spreadsheets, then I would strongly recommend that the validation process is ‘genericised’ by means of standard document templates to allow rapid turnaround.

There is a mini-series of papers available at http://www.spreadsheetvalidation.com describing a “Pragmatic Approach to the Validation of Excel Spreadsheets”. Using this approach we find that the majority of relatively simple spreadsheets (as typically used for data calculation/reporting etc), can be validated in 4-5 days, this includes full documentation and testing.

Comment on Validation Protocol Execution Tips – Top 10 by Muzaffer

Muzaffer — Sat, 20 Feb 2010 13:01:30 +0000

It is a very nice article, as it reminds me actually the things we got during execution. We should do the dry run as real run and must be reviewed by any one else.

Comment on Validation Protocol Execution Tips – Top 10 by davidj

davidj — Fri, 19 Feb 2010 10:08:48 +0000

Good article, although I would say that you dont always have the luxury of starting the protocol when it is convenient for you. I have found that when performing OQ and PQ on plant, you will need trained operatives available (as you wont be allowed to work on the equipment unspervised) and you have to work around them and not the other way round! I have had to execute protocols at the end of the working day, and I know people who have had to work during the night, as it was the only time operators were available!

Would also say that for point 5, you would have the protocol reviewed and approved anyway under GMP. You must NEVER use any unapproved qualification documents!

A tip:
When working on a GMP plant ensure that you have been sufficiently trained to be allowed on plant without supervision (ie gowning procedures) as that can be a real pain if operators are busy and cant spare the time to escort and supervise you. Are you fully trained in the company’s procedures for writing and executing protocols, and deviations? If not – forget doing any validation work!

Comment on Validation of MS Excel Spreadsheets by davidj

davidj — Fri, 19 Feb 2010 09:50:01 +0000

Excelent article! Very clear and straight forward.

My only comment is although it is probably not a problem 99% of the time, be aware of rounding errors when comparing Excel calculations with a calculator, especially where there may be several to many iterations in a calculation! Also if displaying the result to only a few decimal places errors can creep in as Excel calculates to 18 dp (I think) and doing cumlulative calculations can again cause rounding errors. I know, because this has happened to me!

I have also heard of audit trail addons, but I cant vouch for these either.

Comment on Validation of MS Excel Spreadsheets by Val Dater

Val Dater — Thu, 18 Feb 2010 00:27:42 +0000

The problem with the entire concept of validating an Excel spread sheet is that there is no audit trail that comes with an out of the box Excel spreadsheet. Which means there is no way to track if the data has been modified after the original entry, when the modification occurred, why it occurred and who did it. The Excel spread sheet maybe doing the calculations correctly but any auditor worth their salt would not be satisfied with a system carrying out a critical function that did not have an audit trail. There are some third party add-ons that install an audit trail into an excel spread sheet. I am not sure how good these are.

Comment on Validation of MS Excel Spreadsheets by John Kerr

John Kerr — Wed, 17 Feb 2010 20:48:56 +0000

If you do a search for “Printing Formulas To Word” you’ll come across a page by CPearson. The macro will print all the formulas in a selected region in an Excel spreadsheet to a Word document. It saves so much time!
To get the macro to run you need to “Make sure that you have enabled references to Word objects, from the Tools->References menu” in the VB Editor menu which can be confusing for novices to do.
The problem we’ve had with validating Excel spreadsheets is getting the upper echelons to sign off the documents… they just don’t understand it!

Comment on Quality Vs Validation – Protocol Acceptance Criteria by R Hess

R Hess — Tue, 16 Feb 2010 22:46:40 +0000

Interesting that there seems to be such animosity between validation teams and quality teams. I work for a very small company and the quality and validation duties overlap as far as responsible personnel.
I have had to do much educating here on what the purpose of validations are in order to be able to work well with all departments. And truthfully, the manufacturing departments are the most resistant to performing validations.
Maybe this is a strange question, but don’t validation teams want their documents to meet all of the quality standards too? If a question the quality reviewer brings up cannot be answered easily, then maybe the quality reviewer has a point…?
In our company, the quality department handles most of the external audits and must assist in defending documents to customers, ISO auditors, and government auditors. As both a quality and validation position, I definetly don’t want to be caught in a position with an auditor of any kind where I cannot defend or explain any part of a validation document…