Rams69
☆    

Madruai, Tamilnadu, India,
2021-06-04 05:46
(1050 d 05:58 ago)

Posting: # 22390
Views: 1,917
 

 Guidelines [Regulatives / Guidelines]

Dear All,

A kind request please anyone share the recent guidelines soft copies for the following topics,

1) Quality Managemnet System including Risk Management
2) Trend analysis
3) Computer System validation

Please share ASAP.

With Regards,
Thangairulappan S


Edit: Relax; see also this post #9[Helmut]

Information is Wealth,
Thangairulappan S
drgunasakaran1
★★  
avatar

2021-06-07 15:30
(1046 d 20:14 ago)

@ Rams69
Posting: # 22391
Views: 1,646
 

 Guidelines

Dear Mr Thangairulappan,

Kindly go through the below guidance.
WHO's Guidance on VALIDATION OF COMPUTERIZED SYSTEMS
ICH Q10 Pharmaceutical Quality System

Dr S Gunasakaran MBBS MD
Disclaimer: The replies/posts are my personal opinions and it does not represent my company views on the same.
Rams69
☆    

Madruai, Tamilnadu, India,
2021-06-09 06:43
(1045 d 05:00 ago)

@ drgunasakaran1
Posting: # 22393
Views: 1,502
 

 Guidelines

Thank you Dr.

Information is Wealth,
Thangairulappan S
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