Stability Community

Hi everyone,

I've been exploring stability software to bring to the company to prepare for more and more batches that are coming. I'm currently looking at SLIM, Novatek, istability, etc.  I would like to ask the community whether you have experience using software from these vendors or any recommendations on other vendors that I should explore. We are biologics.

Also, do you usually perform IQ, OQ, and PQ on the stability software? I'm not sure it's required.

Thank you!

Wow

Hi everyone,

I've been exploring stability software to bring to the company to prepare for more and more batches that are coming. I'm currently looking at SLIM, Novatek, istability, etc.  I would like to ask the community whether you have experience using software from these vendors or any recommendations on other vendors that I should explore. We are biologics.

Also, do you usually perform IQ, OQ, and PQ on the stability software? I'm not sure it's required.

Thank you!

Wow

Hi Kanyaphat,

I would definitely encourage you to take a look at the Novatek stability software. Although I do not have firsthand experience using it, I have had the opportunity to see a demo of it and was quite impressed and was planning to incorporate it into a global stability program until my position was recently eliminated as part of a reqorganization.

Best wishes,

Ken

Hi everyone,

I've been exploring stability software to bring to the company to prepare for more and more batches that are coming. I'm currently looking at SLIM, Novatek, istability, etc.  I would like to ask the community whether you have experience using software from these vendors or any recommendations on other vendors that I should explore. We are biologics.

Also, do you usually perform IQ, OQ, and PQ on the stability software? I'm not sure it's required.

Thank you!

Wow

Hi everyone,

I've been exploring stability software to bring to the company to prepare for more and more batches that are coming. I'm currently looking at SLIM, Novatek, istability, etc.  I would like to ask the community whether you have experience using software from these vendors or any recommendations on other vendors that I should explore. We are biologics.

Also, do you usually perform IQ, OQ, and PQ on the stability software? I'm not sure it's required.

Thank you!

Wow

Hi Wow,

I also saw a demo of the Novatek software and was impressed by all that it could do. I used Labware LIMS for 15+ years at my past two companies. The same software at one company was a challenge to use but worked quite smoothly at another company. I really think its important how the user requirements are designed. I also used istability for a few months and thought it was easy to use and the stability reports looked great. The only issue was that the out of the box module that generated regression plots seemed to be set up for small molecules and not biologics.

Sherilyn

Hi everyone,

I've been exploring stability software to bring to the company to prepare for more and more batches that are coming. I'm currently looking at SLIM, Novatek, istability, etc.  I would like to ask the community whether you have experience using software from these vendors or any recommendations on other vendors that I should explore. We are biologics.

Also, do you usually perform IQ, OQ, and PQ on the stability software? I'm not sure it's required.

Thank you!

Wow

Hi everyone,

I've been exploring stability software to bring to the company to prepare for more and more batches that are coming. I'm currently looking at SLIM, Novatek, istability, etc.  I would like to ask the community whether you have experience using software from these vendors or any recommendations on other vendors that I should explore. We are biologics.

Also, do you usually perform IQ, OQ, and PQ on the stability software? I'm not sure it's required.

Thank you!

Wow

Hi Wow,

We've been Novatek Stability LIMS users since 2014 and recently upgraded to the newest version, 3.6. I work in devices, not biologics, but I'm sure the software will suit your needs as well. Novatek support is outstanding and the product is very user-friendly! We performed a full validation (IQ, OQ, and PQ) when we implemented Version 3.6 back in December 2023. Novatek will provide the documentation, test scripts, etc. for you to perform the qualification yourself.  It is straight-forward but time consuming.  You certainly can't go wrong if you decide to go with Novatek!

Hi everyone,

I've been exploring stability software to bring to the company to prepare for more and more batches that are coming. I'm currently looking at SLIM, Novatek, istability, etc.  I would like to ask the community whether you have experience using software from these vendors or any recommendations on other vendors that I should explore. We are biologics.

Also, do you usually perform IQ, OQ, and PQ on the stability software? I'm not sure it's required.

Thank you!

Wow