Records and Data - Quality, Legal and Other Evidence

Includes legal and other related records and data discussions. What is a Quality Record and what quality records are required? What other required records are there in your company? Records are Evidence. What is Data?
FAQs
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Record Falsification - What clause to raise a non-conformity?
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Replies
20
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24,052
Bill Levinson
Raffy
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Defining Record Retention Times - Is 5 years long enough?
2 3 4 5
Replies
41
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49,202
Crusader
L
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Certificate of Compliance vs. Conformance - What is the difference?
2 3
Replies
26
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106,459
kasiopeja01
Q
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Training Records - Proof of "training" per ISO 9001 section 6.2.2 (b)
2 3 4
Replies
33
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65,587
joelsivi
V
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Records are a special type of document - Can anyone clarify this statement? 4.2.3
2 3 4
Replies
35
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36,981
joelsivi
N
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Records required by TS16949 - I have identified 26, are there more?
2 3
Replies
29
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30,678
LUV-d-4UM
R
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Identification of Quality Records (ISO9001 - 4.2.4) - How?
2 3 4
Replies
32
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39,915
Jim Wynne
J
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Are email acceptable as records? Email for a customer approval of some part?
2 3
Replies
20
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26,824
Russ
M
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Quality Record Retention Time - ISO 9001 vs. CFR 820.180(b)
2 3
Replies
25
Views
41,643
Trackerii
Discussions
H
Is it a requirement for run charts to have inspection data or can it have just a pass/fail check mark
Replies
4
Views
930
Steve Prevette
C
Bulk Record Retention Review
Replies
4
Views
982
Zero_yield
amjadrana
ISO 13485 Records Retention Requirements
2 3
Replies
22
Views
56,699
AngelaLaw
C
Training Records - AS9100 Requirements
2
Replies
17
Views
14,252
MD13748
S
Placing a calibration sticker with someone other than your initials
Replies
8
Views
1,474
Thee Bouyyy
chris1price
Archiving of paper records - ISO 9001 7.5.3.1b
Replies
4
Views
975
Tagin
B
Complaint Records - Accessing records on Easy Track Software
Replies
3
Views
922
Tagin
E
Record Retention - Raw Material (Steel Certs)
Replies
3
Views
883
Cari Spears
J
Records Control - Does each individual record need to be numbered?
Replies
2
Views
757
Cari Spears
S
Records - Do's and don't' of record entries (FDA - 21 CFR 820)
2
Replies
13
Views
1,846
indubioush
Q
Document approval through SharePoint (without signature)
Replies
4
Views
3,551
Tagin
B
Record Management - Does the QMS need to control templates of records?
2
Replies
17
Views
3,946
Jim Wynne
Crusader
Certificate of Compliance - Put a form number on it or not?
2
Replies
17
Views
5,918
Ninja
T
Record Retention Requirements - IATF 16949 Clause 7.5.3.2.1
2
Replies
15
Views
22,334
Mikey324
M
Loss of a Quality Record - FDA Inspection
Replies
4
Views
1,245
Maryvicki
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