Qualification and Validation (including 21 CFR Part 11)

FAQs
Marc
  • Sticky
ISO 13485 and ISO 14971 - Medical Devices and Related Forums
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0
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10,628
Marc
Discussions
Z
Class 2 medical device - Process Validation - Test sterile or non-sterile units?
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9
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1,801
Muhammad Farooq
L
ASTM F88 Seal Strength of pouches - amount samples per pouch (discussion)
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7
Views
374
Disadolly
Q
  • Locked
Validation Guidance - Plastic Injection Molding Process
2 3 4 5
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46
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54,941
Xiomara
B
SPECIAL PROCESS VALIDATION & REVALIDATION
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5
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828
weldingtorch
A
OpenText Documentum
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2
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127
attrayee
Q
IQ, OQ, PQ and Process Validation Sequence
Replies
8
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9,644
Vittoria
V
Retrospective validation medical devices
Replies
7
Views
308
Vittoria
I
Mixing tank sample points
Replies
4
Views
387
Swimming In The Soup
S
Combo Product Assembly Process OQ
Replies
0
Views
186
sunbike
S
Mixing criteria and sampling
Replies
1
Views
305
v9991
A
FDA Audit Documentation - Recently released FDA Warning Letter
2
Replies
12
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5,124
Wes Bucey
J
Duplicate Band Sealers
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0
Views
166
jess1111
M
Do i need to have equipment validation if 100% testing is completed?
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6
Views
667
chris1price
J
Cloud Based System
Replies
7
Views
491
Jeff007
P
IQ, OQ, PQ protocol, and report templates for Distributed Control Systems in Pharmaceutical Manufacturing Systems.
Replies
1
Views
1,932
Alex Kennedy
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