What is our primary use case?
I use Minitab Statistical Software for trend reviews, such as the Annual Product Quality Review, in the pharmaceutical and biopharmaceutical industries. I also use it to identify outliers in processes and in historical database reviews. In addition, I use it to evaluate databases through different statistical techniques, such as standard deviation, relative standard deviation, normality tests, and process capability index valuation.
In the pharmaceutical industry, we have different products, and as per regulatory requirements, we have to perform the Annual Product Quality Review. Based on that, we identify the batches and specifically apply statistical tools, such as the process capability index, to identify any adverse trend or any outlier from the predefined limit.
We use it across multiple products throughout the year, as we currently evaluate about 30 to 40 products per quarter in Minitab Statistical Software.
We also use Minitab Statistical Software in the stability data evaluation of pharmaceutical products, to identify the impurity profile and to predict the impurity profile based on the various tools available.
How has it helped my organization?
From a regulatory point of view, regulatory agencies question our database techniques and the tools we use multiple times. Minitab Statistical Software is a reputed tool used across various industries, such as the pharmaceutical, biopharmaceutical, and engineering industries. Due to its reputation, we confidently represent the software in front of auditors, which is useful to us.
Due to the automation in Minitab Statistical Software, there are fewer data errors compared to manual work. While applying the various tools, we can apply them manually by formula or calculation, but it takes time and there are more chances of error compared to Minitab Statistical Software, which automatically calculates the process capability, standard deviation, and relative standard deviation. This is helpful, and we get error-free data easily within a second.
What is most valuable?
Minitab Statistical Software works as a validated Excel. We routinely input data in it, and it automatically derives the database from that Excel, plots the graph, and gives the result outcome immediately. This saves us time on statistical evaluation and on adding data to the Excel every time.
Previous methods were manual and Excel-based, where we had to collect the database and put the data in at once, which took time. Here, we are working online, and the database is fed when the batch is complete. This is really helpful at the end of the quarter, as we get a result in one day, which previously took two to three months to get an actual result of data.
What needs improvement?
We can improve Minitab Statistical Software by providing integration with various batch manufacturing records or various other software, such as LIMS, from which it can capture the data automatically. This way, we do not have to maintain the data manually, which also further reduces the chances of error.
For how long have I used the solution?
I have been using Minitab Statistical Software for the last four to five years.
What do I think about the stability of the solution?
To date, it has been stable in my experience and gives the output that we require.
What do I think about the scalability of the solution?
It is scalable in any type of organization and has multiple functionalities helpful in the statistical evaluation of any type of data, making it scalable.
How are customer service and support?
To date, we have not faced any issue regarding the software.
Which solution did I use previously and why did I switch?
We previously used JMP software, and we switched from JMP to Minitab Statistical Software due to its regulatory reputation, its functionality, and its easily adaptable technology, as it is software used worldwide for statistical evaluation.
How was the initial setup?
It is installed on-premises on particular computers based on employees' requirements. Our organization has taken multiple licenses to use depending on the work employees are performing.
What was our ROI?
It saves time as well as manpower because it works within a fraction of a minute, and the databases are online, allowing us to get any information.
What's my experience with pricing, setup cost, and licensing?
I am not part of the setup team or the licensing team, but as far as our renewable licensing is concerned, it is more expensive than other marketed software. However, its functionality is much greater than other marketed software, which is why I think a big organization can easily afford it.
Which other solutions did I evaluate?
We did not evaluate other options because we had fixed that we had to go with Minitab Statistical Software, since we were using JMP at that time, and Minitab Statistical Software is a regulatory requirement by the auditor.
What other advice do I have?
I give it 8 out of 10 due to its functionality, user interface, and multiple statistical tools, which are really helpful during my routine work as well as during regulatory audits.
I value its functionality, its interface, which is easy to understand, and its training mechanism, including the training modules it provides online as well as within the software. These are really helpful for me and my colleagues, which is why I give it 8 out of 10 compared to other market software whose functionality is less than Minitab Statistical Software.
Data provided by Minitab Statistical Software is accurate and reliable, and it is validated software, so there is no issue and no doubt about the data it provides.
If you are going for regulatory audits in a regulated market, specifically in the pharmaceutical and biopharmaceutical industries, you must go for Minitab Statistical Software compared to other marketed software, as it has many more options and is highly reputable in front of regulatory agencies.
Which deployment model are you using for this solution?
On-premises
