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Quality Manual Template for Clinical Research Field

D

Dr_Anita

#1
Dear All,

I work as a manager in Clinical research feild and basically I am responsible for the Data management department .
I would want to implement the standards , I have SOP's and WI's and process flow chart , I am looking forward in comprising this into a Quality manual book.
Can someone share a Quality Manual template or methodology with me?
I will be thrilled to get this
Thanks
Anita:thanx:
 
Elsmar Forum Sponsor

bio_subbu

Super Moderator
#2
Re: Quality Manual

Dear All,

I work as a manager in Clinical research feild and basically I am responsible for the Data management department .
I would want to implement the standards , I have SOP's and WI's and process flow chart , I am looking forward in comprising this into a Quality manual book.
Can someone share a Quality Manual template or methodology with me?
I will be thrilled to get this
Thanks
Anita:thanx:
Dear Dr. Anita

Welcome to Elsmar Cove!

Please check the below Elsmar post attachment link

http://elsmar.com/Forums/fileslist....by=filename&pageamt=2&criteria=quality+manual

Regards

S. Subramaniam
 
D

Dr_Anita

#3
Re: Quality Manual

Thanks a lot. It helped me.
If you find anything specific to Clinica research feild please let me know.
Regards;
Anita:whip:
 
A

AnnetteQA

#4
I too am looking for a template for Clinical Research (CRO specifically) Quality Manual Template. All of the examples I've seen are for manufacturing. Does anyone have a template?
 

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#6
I worked at the Dept of Vet Affairs in research Design Controls. Typically only the requirements of 21 CFR 820.30 are required for research (and part 11 if you use electronic records.)

Dont expect external QA consultants to be of much assistance. When I recruited them for an external audit, they kept stumbling on the "we dont actually make a physical or software product."

What we did consider the product was the outputs of the QMS itself, how many patents were developed, papers written, industry engagements, translations to market, etc.
 
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