Qualification and Validation (including 21 CFR Part 11)

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PLC (Programmable Logic Controller) Qualification Requirements
2
Replies
11
Views
5,714
JaxQC
K
ISO 15189, QA & how to calibration for Balance, refrigerator and centrifuge?
Replies
5
Views
8,789
Kelukelu
Q
IQ / OQ and PQ Project template wanted
2
Replies
12
Views
16,981
Mohammed Gouda
A
Does the V&V (Verification and Validation) belong to Bench Testing for 510k?
Replies
2
Views
2,784
Ronen E
V
21 CFR Part 11 Electronic Data Storage Requirements vs. Paper Records
Replies
2
Views
3,584
BradM
W
Validation of SAP for ERP - Inventory, shipping, and monitoring expiration dates
2
Replies
18
Views
9,936
nine11c2
L
Compliance to 21 CFR Part 11 - Where to start??
2 3
Replies
20
Views
7,898
sueliu - 2012
A
Sample Size for Design Verification (Prototype Testing) for Medical Devices
2
Replies
12
Views
21,344
ctct61t
J
User Requirement Specification (URS) for off the shelf software
Replies
7
Views
8,121
dwebb
S
Is PQ and Performance Verification the same?
Replies
1
Views
2,646
Ajit Basrur
I
Permanence Time Study during a Validation
Replies
4
Views
2,446
The Specialist
S
Which Normality Test more acceptable to FDA; Also, Non-Normal Threshold?
Replies
5
Views
3,677
snakepitt
T
Medical Device Manufacturer Document Control Computer System Validation
Replies
4
Views
3,151
sagai
B
Autoclave Revalidation Methods
Replies
5
Views
4,127
Brotri
D
Verification Requirements in a Machining Process
Replies
6
Views
2,517
RogerG
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