Rams69
☆    

Madruai, Tamilnadu, India,
2021-06-04 05:46
(1849 d 23:46 ago)

Posting: # 22390
Views: 4,594
 

 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
(1846 d 14:02 ago)

@ Rams69
Posting: # 22391
Views: 3,709
 

 Guidelines

Dear Mr Thangairulappan,

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

Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn
Rams69
☆    

Madruai, Tamilnadu, India,
2021-06-09 06:43
(1844 d 22:48 ago)

@ drgunasakaran1
Posting: # 22393
Views: 3,570
 

 Guidelines

Thank you Dr.

Information is Wealth,
Thangairulappan S
UA Flag
Activity
 Admin contact
23,655 posts in 4,993 threads, 1,572 registered users;
365 visitors (0 registered, 365 guests [including 25 identified bots]).
Forum time: 05:32 CEST (Europe/Vienna)

The real struggle is not between the right and the left
but between the party of the thoughtful
and the party of the jerks.    Jimmy Wales

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5