Re: Validation Process

Thanks Sigurd, For a such a detailed explanation, I wish I had powers and
money for hiring a consultant

any way It my Old Place The Process of Validation was very similar to
Programmer it was something Like this

1) For every Program there used a Programmer and a Validator assigned.
2) Both of them were given a set of Specs written by the statistician (for
Both the datasets and Tables )
3) We used to Program independently as per Specs given to Us and end of the
day when the whole Program is completed we used to compare the datasets
using proc compare .
4) Once we have the Proc Compare results 100% validated then we used to
document that .Lst file and Log file.
5) For the Table and Listings we has a similar Process but we One used to
Produce the RTF and other Used to Manually validate the RTF Output

After all these Process we used to take a print out of the Proc Compare and
and Log file Reports and along with the a document .

My question is here is this Process a standard across the Industry or is it
that company policy alone (patented )

I am not sure if there is standard Template for a document for validation of
a dataset and validation of table/listing which has date time and signature
of the programmer and a validator present,

Is there any Folder structure that is suggested by FDA or Ideal way to have
documents Placed .

I am also curious if there is better way of doing the Process of
Implementing the independent Programming Process. For example one of my
friends while talking said that in their team they do not know who the
Programmer is and who is validator as they would be located in two
different Physical Locations.

I am sure there are lot gurus here who have been doing validation process
for a while if they can share their Ideas and suggestions , I would be
thankful for them. Suggestions for

1) Folder Structure
2) Document Template
3) Naming conventions
4) Writing Specs
5) Reports to be documented (SAS files )
6) Any other things That I have missed here

thanks all for your time and reply's




On Nov 29, 2007 10:28 PM, Sigurd Hermansen <HERMANS1@westat.com> wrote:

> See http://www.fda.gov/CDER/GUIDANCE/pv.htm
>
> Specifically,
> "The FDA defines process validation as follows:
>
> Process validation is establishing documented evidence which provides a
> high degree of assurance that a specific process will consistently
> produce a product meeting its pre-determined specifications and quality
> characteristics.
>
> It is important that the manufacturer prepare a written validation
> protocol which specifies the procedures (and tests) to be conducted and
> the data to be collected. The purpose for which data are collected must
> be clear, the data must reflect facts and be collected carefully and
> accurately. The protocol should specify a sufficient number of replicate
> process runs to demonstrate reproducibility and provide an accurate
> measure of variability among successive runs. The test conditions for
> these runs should encompass upper and lower processing limits and
> circumstances, including those within standard operating procedures,
> which pose the greatest chance of process or product failure compared to
> ideal conditions; such conditions have become widely known as "worst
> case" conditions. (They are sometimes called "most appropriate
> challenge" conditions.) Validation documentation should include evidence
> of the suitability of materials and the performance and reliability of
> equipment and systems.
>
> Key process variables should be monitored and documented. Analysis of
> the data collected from monitoring will establish the variability of
> process parameters for individual runs and will establish whether or not
> the equipment and process controls are adequate to assure that product
> specifications are met.
>
> Finished product and in-process test data can be of value in process
> validation, particularly in those situations where quality attributes
> and variabilities can be readily measured. Where finished (or
> in-process) testing cannot adequately measure certain attributes,
> process validation should be derived primarily from qualification of
> each system used in production and from consideration of the interaction
> of the various systems."
>
> While this definition of "validation" pertains to manufacturing
> operations, it actually makes better sense when applied to programs than
> much of the second-hand IT validation stuff that I've seen. The phrases
> 'documented evidence', 'high degree of assurance', 'consistently
> produce', 'pre-determined specifications', 'quality characteristics'.
> 'data must reflect facts', 'upper and lower processing limits and
> circumstances', and '"worst case" conditions' tell the whole story. All
> this seems to me to be basic testing and quality control. Pro forma
> compliance to SOP and sign off's don't contribute much to essential
> quality control methods.
>
> Give someone other than the author an opportunity to break a SAS Macro
> or a program. If a diligent effort to cause it to fail does not succeed,
> try to determine why it has to work properly. Short of proof of
> correctness of programs, that should be adequate. This level of FDA
> validation really doesn't differ from what every group of programmers
> should do to control quality of their work.
>
> I'd recommend that you hire a consultant who has demonstrated QC skills
> on SAS-L (obviously not me!). You will not only sleep easier, you will
> also learn more than you could learn by spending an equivalent amount on
> How to Validate seminars.
> S
>
> -----Original Message-----
> From: owner-sas-l@listserv.uga.edu [mailtowner-sas-l@listserv.uga.edu]
> On Behalf Of SAS_learner
> Sent: Wednesday, November 28, 2007 9:14 PM
> To: SAS(r) Discussion
> Subject: Validation Process
>
>
> Hell _all_ ,
>
> I think this Topic must have discussed earlier as it is very old Topic
> We are in Process of setting up validation Process for a Clinical
> submission,
>
> I am looking for a paper or Place or any suggestions to Formally set a
> validation Process. I know Most of the Pharmaceutical company's or the
> Big CRO's they have Lot of Validated Macro's. Here we are Process of
> setting up whole validation process from Scratch.
>
> I am looking for some Place where there info about
> 1)Validation documents
> 2)Validation Procedures
>
> Any books on validation Process which is acceptable by FDA. Thanks for
> all the help
>
> thanks
>
> thanks
>