LIMSforum Discussions

Votes Comments	Discussion
0 votes 1 comment	Computerised System Periodic Review Started 4 months ago by Patrick Devine updated 4 months ago by Jeremy Dowling Category: Computer Systems Validation (CSV)
7 votes 5 comments	Using Adobe's Certificate/Signature functionality for documents Started 6 months ago by Pranav Dalal updated 6 months ago by Pranav Dalal Category: Computer Systems Validation (CSV)
8 votes 7 comments	Validation documentation storage Started 6 months ago by Anna Petrovskaya updated 6 months ago by Greg Ventura Category: Computer Systems Validation (CSV)
18 votes 15 comments	Excel Validation Started 7 months ago by Pranav Dalal updated 6 months ago by David Bruun-Petersen Category: Computer Systems Validation (CSV)
4 votes 11 comments	Laser Engraving system Started 7 months ago by Julien Framery updated 6 months ago by Srinath Y G Category: Computer Systems Validation (CSV)
6 votes 7 comments	User requirements specification (URS) writing Started 7 months ago by Anand Pandya updated 6 months ago by Bob McDowall 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 7 months ago by Jayant Gajbhiye updated 6 months ago by Jayant Gajbhiye Category: Computer Systems Validation (CSV)
0 votes 4 comments	Does the end user require Factory Acceptances Testing records ( commercial & customised instruments ) since its not clearly indicated in USP 1058 draft Started 7 months ago by Anand Pandya updated 7 months ago by Anand Pandya Category: Computer Systems Validation (CSV)
0 votes 1 comment	ISO 80002/2 Started 7 months ago by Micheli Lermen updated 7 months ago by Ulrich Köllisch Category: Computer Systems Validation (CSV)
4 votes 13 comments	Regulated company does not want to perform UAT - is it compliant? Started 7 months ago by Natalia Blagodarova updated 7 months ago by Darshan Reddy Category: Computer Systems Validation (CSV)
9 votes 27 comments	"Windows XP = non-compliance?" and how to fix this gap? Started 7 months ago by DAWEI HU updated 7 months ago by SALOUA NJIM CHEIKH Category: Computer Systems Validation (CSV)
3 votes 6 comments	Executing Code Review Started 8 months ago by kasirajan hariraman updated 7 months ago by Raghu Chikkamuniyappa , ITIL® v3,EU GDPR Certified Category: Computer Systems Validation (CSV)
0 votes 4 comments	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 8 months ago by Kristine Camille Castillo updated 7 months ago by Kristine Camille Castillo Category: Computer Systems Validation (CSV)
5 votes 5 comments	CSV'an ,Shade light on Verification Quality Assessment (System VQA) and Verification Test Plan (VTP) - Purpose, Why, How and When?? Started 8 months ago by Jayant Gajbhiye updated 8 months ago by Sheila Como Category: Computer Systems Validation (CSV)
3 votes 6 comments	Wondering whether some people in this group have experience in validating middleware software used to integrate GxP related systems? Started 8 months ago by Kris Van Hemelrijck updated 7 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 8 months ago by John English, HCCP updated 7 months ago by Carlos Viera-Tirado Category: Computer Systems Validation (CSV)
4 votes 9 comments	How to document the non-conformity Started 8 months ago by Sachin Shinde updated 8 months ago by Manmeet Kapur Category: Computer Systems Validation (CSV)
9 votes 10 comments	In Stand-alone Computerized System, what if I, one QC junior analyst, access BIOS to change system date&time? Started 8 months ago by DAWEI HU updated 8 months ago by Santosh Kumar Bavisetti Category: Computer Systems Validation (CSV)
1 vote 2 comments	Where can I acquire an updated GxP Assessment Form? Started 8 months ago by Loganathan Kumarasamy updated 8 months ago by Winrich Germann Category: Computer Systems Validation (CSV)
7 votes 12 comments	How to conduct retrospective validation of a computer system? Started 8 months ago by kasirajan hariraman updated 8 months ago by Heather Longden Category: Computer Systems Validation (CSV)

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