Stability Community

This message was posted by a user wishing to remain anonymous

I wanted to ask our community members if you recommend any Off-The-Shelf Stability Programs which can be validated (Part11 compliant).  I am aware of iStability LIMS (Scientek Software) and am looking for other similar/better programs with the following capabilities: Data Management, Analysis (trending capabilities), and Report generation.

NOTE:  This question was initially submitted to the AAPS Stability Community's email distribution list and shared anonymously here in the Stability Discussion Topics with the permission of the questioner.

This message was posted by a user wishing to remain anonymous

We use LabWare – it has zero data stability (regression) trending analytics.  All of the data must be exported and analyzed in a Validated Statistical Analytics Tool.  For us, MiniTab.  This is not very efficient.

We are presently looking at other Stability LIMS platforms.

I also have experience with NovaLIMS by Novatek – it had better stability trending reporting functionality built in.

Original Message:
Sent: 02-20-2024 14:42
From: Anonymous Member
Subject: Experience with validated Stability LIMS software?

This message was posted by a user wishing to remain anonymous

I wanted to ask our community members if you recommend any Off-The-Shelf Stability Programs which can be validated (Part11 compliant).  I am aware of iStability LIMS (Scientek Software) and am looking for other similar/better programs with the following capabilities: Data Management, Analysis (trending capabilities), and Report generation.

NOTE:  This question was initially submitted to the AAPS Stability Community's email distribution list and shared anonymously here in the Stability Discussion Topics with the permission of the questioner.

This message was posted by a user wishing to remain anonymous

I also have experience with NovaLIMS by Novatek – it had better stability trending reporting functionality built in.

We have Novatek Stability-LIMS and it has served us well since our initial implementation in 2014.  It is COTS software, but we added some customization since my company is medical device and not pharma.  We have 15 users (clients), and the SQL DB is stored on our Azure Cloud.

We just upgraded to Version 3.6 and completed the entire qualification/validation (IQ, OQ, PQ) process.  It is 21 CFR Part 11 compliant (audit trails, electronic signatures, etc.).  Version 3.6 also includes an embedded electronic lab notebook.

The software has sample and inventory management with bar codes and trend analysis (regression analysis, including comparison of slopes and intercepts for data pooling).

Novatek provides 20 or so, canned reports, which are good and suitable for our purposes.  The only downside is that you can't customize these reports (other than adding a company logo), so if you need a different report than what Novatek offers, you will have to pay them to design a custom report for you.

I'm a very satisfied Novatek user!

NOTE:  This response was initially provided to the AAPS Stability Community's email distribution list and shared anonymously here in the Stability Discussion Topics with the permission of the responder.

Original Message:
Sent: 02-20-2024 14:43
From: Anonymous Member
Subject: Experience with validated Stability LIMS software?

This message was posted by a user wishing to remain anonymous

We use LabWare – it has zero data stability (regression) trending analytics.  All of the data must be exported and analyzed in a Validated Statistical Analytics Tool.  For us, MiniTab.  This is not very efficient.

We are presently looking at other Stability LIMS platforms.

I also have experience with NovaLIMS by Novatek – it had better stability trending reporting functionality built in.

Original Message:
Sent: 02-20-2024 14:42
From: Anonymous Member
Subject: Experience with validated Stability LIMS software?

This message was posted by a user wishing to remain anonymous

I wanted to ask our community members if you recommend any Off-The-Shelf Stability Programs which can be validated (Part11 compliant).  I am aware of iStability LIMS (Scientek Software) and am looking for other similar/better programs with the following capabilities: Data Management, Analysis (trending capabilities), and Report generation.

NOTE:  This question was initially submitted to the AAPS Stability Community's email distribution list and shared anonymously here in the Stability Discussion Topics with the permission of the questioner.

This message was posted by a user wishing to remain anonymous

I like Novatek also.  I'm not an "authorized" user, but I evaluated them before and had many discussions with them regarding stability data reports and data evaluation.  In fact, I like their technical knowledge enough to ask them to contribute the last chapter "LIMS and Electronic Data" in my latest GMP book, and they did a fantastic job!  I do agree with Chris about the customization though, but that would ease the implementation and get you off the ground running.  They are also linked with many other data management areas, not just stability LIMS.

NOTE:  This response was initially provided to the AAPS Stability Community's email distribution list and shared anonymously here in the Stability Discussion Topics with the permission of the responder.

Original Message:
Sent: 02-20-2024 14:42
From: Anonymous Member
Subject: Experience with validated Stability LIMS software?

This message was posted by a user wishing to remain anonymous

I wanted to ask our community members if you recommend any Off-The-Shelf Stability Programs which can be validated (Part11 compliant).  I am aware of iStability LIMS (Scientek Software) and am looking for other similar/better programs with the following capabilities: Data Management, Analysis (trending capabilities), and Report generation.

NOTE:  This question was initially submitted to the AAPS Stability Community's email distribution list and shared anonymously here in the Stability Discussion Topics with the permission of the questioner.

This message was posted by a user wishing to remain anonymous

We use LabWare (and multiple versions too).  Stability trending is performed in a proprietary "Validated Statistical Analytics Tool".  The challenges we face is the exporting of data into a single or combined source file (i.e. verified) to enable such analytics. 

I would be interested in other platforms/suites of validated statistical analytical tools that are "off the shelf" and readily adapted by the industry.

NOTE:  This response was initially provided to the AAPS Stability Community's email distribution list and shared anonymously here in the Stability Discussion Topics with the permission of the responder.

Original Message:
Sent: 02-20-2024 14:42
From: Anonymous Member
Subject: Experience with validated Stability LIMS software?

This message was posted by a user wishing to remain anonymous

I wanted to ask our community members if you recommend any Off-The-Shelf Stability Programs which can be validated (Part11 compliant).  I am aware of iStability LIMS (Scientek Software) and am looking for other similar/better programs with the following capabilities: Data Management, Analysis (trending capabilities), and Report generation.

NOTE:  This question was initially submitted to the AAPS Stability Community's email distribution list and shared anonymously here in the Stability Discussion Topics with the permission of the questioner.

I have used Labware in conjunction with BIOVIA Discoverant to perform routine stability trending and to export data for manual analysis.  Discoverant takes some effort to setup for stability trending, but has some nice functionality such automated alerts for out of trend results.  It was also very useful to use to export data from Labware without the need for additional data verification.

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Dan Willingmyre
Vir Biotechnology, Inc.
Associate Director, Stability & Data Analytics

Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
------------------------------

Original Message:
Sent: 02-20-2024 14:42
From: Anonymous Member
Subject: Experience with validated Stability LIMS software?

This message was posted by a user wishing to remain anonymous

I wanted to ask our community members if you recommend any Off-The-Shelf Stability Programs which can be validated (Part11 compliant).  I am aware of iStability LIMS (Scientek Software) and am looking for other similar/better programs with the following capabilities: Data Management, Analysis (trending capabilities), and Report generation.

NOTE:  This question was initially submitted to the AAPS Stability Community's email distribution list and shared anonymously here in the Stability Discussion Topics with the permission of the questioner.