Computer Systems Validation (CSV) (505)

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Computerised System Periodic Review
Started 1 month ago by Patrick Devine
updated 1 month ago by Jeremy Dowling
Category: Computer Systems Validation (CSV)
7
votes
5
comments
Using Adobe's Certificate/Signature functionality for documents
Started 3 months ago by Pranav Dalal
updated 3 months ago by Pranav Dalal
Category: Computer Systems Validation (CSV)
8
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7
comments
Validation documentation storage
Started 4 months ago by Anna Petrovskaya
updated 3 months ago by Greg Ventura
Category: Computer Systems Validation (CSV)
18
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15
comments
Excel Validation
Started 4 months ago by Pranav Dalal
updated 3 months ago by David Bruun-Petersen
Category: Computer Systems Validation (CSV)
6
votes
7
comments
User requirements specification (URS) writing
Started 4 months ago by Anand Pandya
updated 4 months ago by Bob McDowall
Category: Computer Systems Validation (CSV)
4
votes
11
comments
Laser Engraving system
Started 4 months ago by Julien Framery
updated 4 months ago by Srinath Y G
Category: Computer Systems Validation (CSV)
1
vote
10
comments
I would like to know- How does Quality Management System (ISO standard) helps to improve Quality in pharmaceutical industry . If QMS does then what CSV do? And Does QMS compliance FDA regulatory?
Started 4 months ago by Jayant Gajbhiye
updated 4 months ago by Jayant Gajbhiye
Category: Computer Systems Validation (CSV)
0
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4
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Does the end user require Factory Acceptances Testing records ( commercial & customised instruments ) since its not clearly indicated in USP 1058 draft
Started 4 months ago by Anand Pandya
updated 4 months ago by Anand Pandya
Category: Computer Systems Validation (CSV)
0
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1
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ISO 80002/2
Started 4 months ago by Micheli Lermen
updated 4 months ago by Ulrich Köllisch
Category: Computer Systems Validation (CSV)
4
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13
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Regulated company does not want to perform UAT - is it compliant?
Started 5 months ago by Natalia Blagodarova
updated 4 months ago by Darshan Reddy
Category: Computer Systems Validation (CSV)
9
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27
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"Windows XP = non-compliance?" and how to fix this gap?
Started 5 months ago by DAWEI HU
updated 5 months ago by SALOUA NJIM CHEIKH
Category: Computer Systems Validation (CSV)
3
votes
6
comments
Executing Code Review
Started 5 months ago by kasirajan hariraman
updated 5 months ago by Raghu Chikkamuniyappa , ITIL® v3,EU GDPR Certified
Category: Computer Systems Validation (CSV)
0
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4
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How do we ensure that the built-in automated qualification tool used for qualifying the installation, operation and performance of a CDS system i.e Chromeleon IOQ, Empower SQT is validated?
Started 5 months ago by Kristine Camille Castillo
updated 5 months ago by Kristine Camille Castillo
Category: Computer Systems Validation (CSV)
5
votes
5
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CSV'an ,Shade light on Verification Quality Assessment (System VQA) and Verification Test Plan (VTP) - Purpose, Why, How and When??
Started 5 months ago by Jayant Gajbhiye
updated 5 months ago by Sheila Como
Category: Computer Systems Validation (CSV)
3
votes
6
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Wondering whether some people in this group have experience in validating middleware software used to integrate GxP related systems?
Started 5 months ago by Kris Van Hemelrijck
updated 5 months ago by Keary Donovan
Category: Computer Systems Validation (CSV)
26
votes
10
comments
Would you write a CSV Plan for CDS with "no direct testing?" Yes, there's a 483 here.
Started 6 months ago by John English, HCCP
updated 5 months ago by Carlos Viera-Tirado
Category: Computer Systems Validation (CSV)
4
votes
9
comments
How to document the non-conformity
Started 6 months ago by Sachin Shinde
updated 5 months ago by Manmeet Kapur
Category: Computer Systems Validation (CSV)
9
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10
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In Stand-alone Computerized System, what if I, one QC junior analyst, access BIOS to change system date&time?
Started 6 months ago by DAWEI HU
updated 5 months ago by Santosh Kumar Bavisetti
Category: Computer Systems Validation (CSV)
1
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2
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Where can I acquire an updated GxP Assessment Form?
Started 6 months ago by Loganathan Kumarasamy
updated 6 months ago by Winrich Germann
Category: Computer Systems Validation (CSV)
7
votes
12
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How to conduct retrospective validation of a computer system?
Started 6 months ago by kasirajan hariraman
updated 6 months ago by Heather Longden
Category: Computer Systems Validation (CSV)
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