Computer Systems Validation (CSV) (507)

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Need to adapt Agile development methodology for regulatory environment via JIRA tool
Started 9 months ago by Reddy
Category: Computer Systems Validation (CSV)
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1
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DELIVERABLE DOCUMENTS FOR GAMP 4
Started 11 months ago by bakuru venkatanaidu
Category: Computer Systems Validation (CSV)
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1
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Computerised System Periodic Review
Started 1 year ago by Patrick Devine
Category: Computer Systems Validation (CSV)
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5
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Using Adobe's Certificate/Signature functionality for documents
Started 1 year ago by Pranav Dalal
Category: Computer Systems Validation (CSV)
8
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7
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Validation documentation storage
Started 1 year ago by Anna Petrovskaya
Category: Computer Systems Validation (CSV)
18
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15
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Excel Validation
Started 1 year ago by Pranav Dalal
Category: Computer Systems Validation (CSV)
4
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11
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Laser Engraving system
Started 1 year ago by Julien Framery
Category: Computer Systems Validation (CSV)
6
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7
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User requirements specification (URS) writing
Started 1 year ago by Anand Pandya
Category: Computer Systems Validation (CSV)
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10
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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 1 year ago by Jayant Gajbhiye
Category: Computer Systems Validation (CSV)
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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 1 year ago by Anand Pandya
Category: Computer Systems Validation (CSV)
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ISO 80002/2
Started 2 years ago by Micheli Lermen
Category: Computer Systems Validation (CSV)
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13
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Regulated company does not want to perform UAT - is it compliant?
Started 2 years ago by Natalia Blagodarova
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 2 years ago by DAWEI HU
Category: Computer Systems Validation (CSV)
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6
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Executing Code Review
Started 2 years ago by kasirajan hariraman
Category: Computer Systems Validation (CSV)
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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 2 years ago by Kristine Camille Castillo
Category: Computer Systems Validation (CSV)
5
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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 2 years ago by Jayant Gajbhiye
Category: Computer Systems Validation (CSV)
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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 2 years ago by Kris Van Hemelrijck
Category: Computer Systems Validation (CSV)
26
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10
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Would you write a CSV Plan for CDS with "no direct testing?" Yes, there's a 483 here.
Started 2 years ago by John English, HCCP
Category: Computer Systems Validation (CSV)
4
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9
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How to document the non-conformity
Started 2 years ago by Sachin Shinde
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 2 years ago by DAWEI HU
Category: Computer Systems Validation (CSV)
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