Qualification and Validation (including 21 CFR Part 11)

FAQs
Marc
  • Sticky
ISO 13485 and ISO 14971 - Medical Devices and Related Forums
Replies
0
Views
5,540
Marc
Discussions
Ed Panek
Do Cloud services require 21 CFR Part 11 compliance?
Replies
7
Views
315
JJ_FDA
Q
Validation Guidance - Plastic Injection Molding Process
2 3
Replies
28
Views
41,866
somashekar
A
System for Compliance Management (Medical Device)
Replies
3
Views
428
tnorton
A
Validating my own application developed with Agile
Replies
5
Views
125
Andrea102
F
Organising IQ, OQ and PQ content in a "smart" way
Replies
3
Views
222
yodon
S
Do we need to validate Software used in Drug discovery and development process?
Replies
2
Views
163
JJ_FDA
M
Accredited Calibration Sevice Provider using computerized system to issue calibration certificate
Replies
3
Views
169
dwperron
O
Validation approach for a Photostability Chamber (used for fluid therapy and injectable drug products)
Replies
1
Views
167
John Broomfield
K
Computerized system Master Validation Plan, IQ-OQ-PQ Draft or Template
Replies
4
Views
3,317
Alex Kennedy
M
Suggestions for Electronic Signature Software (FDA 21 CFR Part 11 Compliant)
2
Replies
10
Views
2,112
Enka_Spy
S
Validation of COTS Equipment plus Software
Replies
5
Views
229
Ajit Basrur
J
Business Intelligence and 21 CFR Part 11 Compliance
Replies
1
Views
193
yodon
G
Correction fluid found on documents that are reviewed
2
Replies
11
Views
544
gpalow
J
Welding Process Validation Plan
2
Replies
19
Views
12,010
MatthewBlaine
I
CAP/CLIA Environment - Part 11 Compliance
Replies
3
Views
189
Ronen E
You must log in or register to post here.
Top Bottom