Qualification and Validation (including 21 CFR Part 11)

A
Validation of an Excel Spreadsheet used for Recording Test Results
2
Replies
14
Views
7,089
achorste
N
Software Requirements specification vs. Design Specification - Differences
2
Replies
10
Views
23,308
Dindo
K
EN550 (ISO 11135-1:2007) - ETO (Ethylene Oxide) Validation
Replies
5
Views
8,257
Ajit Basrur
Penguin
Requirements for software providers for the medical device field
Replies
5
Views
2,064
alex.Kennedy
R
Process Validation Issues - Active Pharmaceutical Ingredients
Replies
2
Views
2,669
raghu_1968
F
Is self-serve password reset for Windows considered for validation under CFR Part 11
Replies
2
Views
1,899
BradM
R
Which Date (start/end of analysis) should be considered as Date of analysis?
Replies
2
Views
1,683
Ajit Basrur
Ajit Basrur
Should the Protocol and Report be signed by the same person(s)?
Replies
7
Views
2,776
Ajit Basrur
S
Medical devices, VMP and product Validation
2
Replies
11
Views
5,311
Juan Dude
J
Electronic Signature Validation Protocol example or template
Replies
2
Views
5,892
Juan Dude
M
Soldering Process Validation
Replies
3
Views
8,400
Nissim Shaked
K
21 CFR part 11 & CRM software (including customer support)
Replies
5
Views
2,101
Ajit Basrur
C
Do I have to establish a software validation procedure?
2
Replies
11
Views
4,250
Norris Dale
M
21 CFR Part 11 European Equivalent
Replies
3
Views
6,044
Jerome
B
Packaging Validation - Storage Distribution Testing
Replies
4
Views
2,717
Jimmy the Brit
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