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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5,315
Marc
Discussions
O
Validation approach for a Photostability Chamber (used for fluid therapy and injectable drug products)
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0
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47
Omar D
J
Business Intelligence and 21 CFR Part 11 Compliance
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1
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94
yodon
G
Correction fluid found on documents that are reviewed
2
Replies
11
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371
gpalow
J
Welding Process Validation Plan
2
Replies
19
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11,681
MatthewBlaine
I
CAP/CLIA Environment - Part 11 Compliance
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3
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119
Ronen E
V
AHU (Air Handler Units) and Clean Room References
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3
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2,652
sobyjoseph
D
Software Validation - Contract manufacturer of Components (PCBA's)
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7
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301
yodon
V
  • Poll
Open vs Closed Systems - Criteria for Categorization in cGMP Environment
Replies
4
Views
8,098
melancholy
V
Periodic Audit Trail Review - Scope, Content & Frequency
2
Replies
10
Views
5,924
melancholy
I
HEPA Filter Integrity test ISO class 9 room
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2
Views
157
Chaitany Thaker
Z
Security for Approvals - Cloud based Complaint, NC, and CAPA systems
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8
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192
Ronen E
A
System for Compliance Management (Medical Device)
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4
Views
313
Andrea102
C
In cases where users of an electronic system change their names
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6
Views
348
rogerpenna
Z
Class 2 medical device - Process Validation - Test sterile or non-sterile units?
Replies
4
Views
300
yodon
lilybef
Number of lots required for stability testing of a Class II device in the 510(k)
Replies
3
Views
305
lilybef
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Uncompensated Courtesy Links Elsmar Cove visitors will find useful in the quest for knowledge and support:

Elsmar Business Services

Jennifer Kirley's
Conway Business Services

Marcelo Antunes'
SQR Consulting, and
Medical Devices Expert Forum

Bob Doering
Bob Doering's Blogs and,
Correct SPC - Precision Machining

Ajit Basrur
Claritas Consulting, LLC

International Standards Bodies - World Wide Standards Bodies

AIAG - Automotive Industry Action Group

ASQ - American Society for Quality

International Organization for Standardization - ISO Standards and Information

NIST's Engineering Statistics Handbook

IRCA - International Register of Certified Auditors

SAE - Society of Automotive Engineers

Quality Digest

IEST - Institute of Environmental Sciences and Technology
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