LIMSforum Discussions

Votes Comments	Discussion
0 votes 1 comment	ISO 80002/2 Started 3 weeks ago by Micheli Lermen updated 2 weeks 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 3 weeks ago by Natalia Blagodarova updated 1 week ago by Darshan Reddy Category: Computer Systems Validation (CSV)
9 votes 27 comments	"Windows XP = non-compliance?" and how to fix this gap? Started 1 month ago by DAWEI HU updated 3 weeks ago by SALOUA NJIM CHEIKH Category: Computer Systems Validation (CSV)
3 votes 6 comments	Executing Code Review Started 1 month ago by kasirajan hariraman updated 1 month 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 1 month ago by Kristine Camille Castillo updated 1 month 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 1 month ago by Jayant Gajbhiye updated 1 month ago by Sheila Como Category: Computer Systems Validation (CSV)
2 votes 6 comments	Wondering whether some people in this group have experience in validating middleware software used to integrate GxP related systems? Started 1 month ago by Kris Van Hemelrijck updated 3 weeks 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 1 month ago by John English, HCCP updated 1 month ago by Carlos Viera-Tirado Category: Computer Systems Validation (CSV)
4 votes 9 comments	How to document the non-conformity Started 1 month ago by Sachin Shinde updated 1 month 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 1 month ago by DAWEI HU updated 1 month ago by Santosh Kumar Bavisetti Category: Computer Systems Validation (CSV)
1 vote 2 comments	Where can I acquire an updated GxP Assessment Form? Started 2 months ago by Loganathan Kumarasamy updated 1 month ago by Winrich Germann Category: Computer Systems Validation (CSV)
7 votes 12 comments	How to conduct retrospective validation of a computer system? Started 2 months ago by kasirajan hariraman updated 1 month ago by Heather Longden Category: Computer Systems Validation (CSV)
1 vote 8 comments	Test Management Software Started 2 months ago by Luzi Jakob Barandun updated 1 month ago by Winrich Germann Category: Computer Systems Validation (CSV)
7 votes 12 comments	Is E-signature is Must for "Excel Print-Out Label in Production Area " Started 2 months ago by DAWEI HU updated 2 months ago by DAWEI HU Category: Computer Systems Validation (CSV)
11 votes 13 comments	Should a QA have deep knowledge on what level of testing to be planned based on the Risk Impact determined? Or is it enough for a Test Manager in a project to have that insight? Started 2 months ago by kasirajan hariraman updated 1 month ago by Lou Ragni, CQE, CQA Category: Computer Systems Validation (CSV)
27 votes 30 comments	GAMP 5 Application in Amazon AWS Cloud Started 2 months ago by Andreas Kühnel updated 1 month ago by Gary Lawless Category: Computer Systems Validation (CSV)
7 votes 7 comments	For a GxP system, How to conduct Risk impact determination? Who will drive this exercise? Who are all to be consulted? Is there anything like Risk level VsTest level Matrix? Started 2 months ago by kasirajan hariraman updated 2 months ago by kasirajan hariraman Category: Computer Systems Validation (CSV)
41 votes 22 comments	New Phase addition to V Model accelerates GMP Automations in Pharma Industry!!!We have seen success in this model. Request your expert views on this please Started 2 months ago by Venkanna Chowdary Manne updated 2 months ago by Lou Ragni, CQE, CQA Category: Computer Systems Validation (CSV)
20 votes 2 comments	A parable on why 'computer Validation' is necessary - the Theranos example Started 2 months ago by John English, HCCP updated 2 months ago by Lou Ragni, CQE, CQA Category: Computer Systems Validation (CSV)
29 votes 36 comments	Audit Trail Periodic Review Started 2 months ago by Tanti Mastika updated 1 month ago by Hasanul Murad Category: Computer Systems Validation (CSV)