Spotfire in combination with Statistica makes it possible to automate analytical processes of highest complexity, have them easily controlled via an intuitive UI and make them available to all relevant stakeholders.
StatSoft has used these capabilities to create a solution for stability analysis (also stability testing, shelf-life estimation) that satisfies highest requirements of customers in pharmaceutical manufacturing.
In this interview with one of our experts we want to answer the most important questions.
Simon Kamprath is a Senior Data Engineer and works with StatSoft since 2017. He is building analytical solutions for our clients in biotechnology, the pharmaceutical industry and in manufacturing.
Simon’s areas of expertise include automation and customization, open source development, process monitoring and validated reporting.
What is stability analysis and what is it used for?
Simon Kamprath: Stability analysis estimates the expected shelf-life of a pharmaceutical product. It is a mandatory process when bringing pharmaceutical products to the market. The customers can see this information as “Best Before” or “EXP” on the packaging.
Newly developed drugs are initially analyzed based on only few batches. When the production is picked up after the initial regulatory approval, sample batches for further analysis are stored and included in the analysis to expand the expected shelf life.
At the time of the approval, the drug has never been stored for as long as the assumed shelf life. That is why regression is used to interpolate the accumulated data. The confidence interval of the worst batch defines the expected shelf-life. With an analysis of covariance, combining multiple batches in the regression can be justified. This leads to more observations and in turn to narrower confidence intervals that statistically justify a longer expected shelf-life.
Who are the experts that use stability analysis at the company?
Simon Kamprath: Stability analysis is conducted by qualified personnel (oftentimes with quality or stability role) in departments like R&D, the laboratory, in production or QA.
What are the requirements for a stability solution?
Simon Kamprath: The solution must adhere to regulatory requirements like the ICH guidelines (ICH Q1A and ICH Q1E - the international standards for evaluation of stability data for pharmaceuticals), GxP-compliance and requirements from regulatory entities (FDA & EMA) as well as customer specific requirements and work instructions. The statistical procedures are described in these requirements.
The user interface has to be intuitive enough so that also non-statisticians can interact with it.
The results have to be available as reports, that can be provided to the regulatory entities and be used for internal reporting.
How do you work with the Statsoft solution? What data sources are being used?
Simon Kamprath: Stability analysis is a mandatory requirement, so customers must have a “solution” in operation. However it is often a manual process that requires qualified personnel.
With the help and experience of StatSoft the process can be automated with the NoCode/LowCode analytical platform Statistica. Through Spotfire the solution gets an intuitive user interface and explorable results. Additionally reports can be generated.
Analytical core of the StatSoft solution is the stability analysis module of Statistica. It adheres to the aforementioned guidelines and offers flexible configuration. It enables the customers (and its customers) to integrate individual requirements for configuration and result delivery. The integration of Spotfire allows to explore results in an interactive dashboard with drilling and filtering capability that can be tailored to any user.
In combination with Statistica components developed by StatSoft, reports based on the analytical results can be created based on templates and be distributed automatically. The specific contents of the reports can be selected by the customers themselves.
The StatSoft solution can integrate any data source. For stability analysis this usually encompassed the connection to the database of the LIMS (Laboratory-Information-Management-System) or SLIM (Stability Lab Information Management). Other data sources can be integrated as well.
What are the benefits of the StatSoft solution?
Simon Kamprath: The StatSoft solution can be set-up very flexibly regarding the configuration and result delivery.
- Simple to configure webforms (data entry setups) allow manual data entry in accordance with FDA 21 CFR Part 11 and ALCOA+.
- Quick installation and set-up through the use of many standard components like Statistica, Spotfire and the StatSoft Report Node.
- Expandability of the analytical architecture for example to integrate future data sources etc.
- NoCode/LowCode approach avoids black boxes. This lets customers stay in control over the solution and be able to modify and optimize it.
- Degree of automation according to the requirements: manual operation, partly and full automation are possible.
We have heard many benefits. How do you get started, where do you begin?
Simon Kamprath: Based on a review of existing working instructions/SOPs and an analysis of example reports the requirements can be formulated in a user requirements specification (URS). Attention should also be given to the availability of data. Is data already in a LIMS, can the data be accessed by the analytical system? Are the specifications (limits) for all measurements available in the same system or do they need to be imported from somewhere else? How are measurements and specifications matched?
Afterwards the first example reports can be designed in a proof-of-concept (POC).
Stability analysis is an important use case. Can other analytical scenarios be tackled as well like site comparisons, trending or process control?
Simon Kamprath: Through the modularity of the solution by employing of-the-shelf analytical software products (Statistica, Spotfire) and through the StatSoft know-how, it is possible to tackle other common use cases of the pharmaceutical industry.
It is possible to add further analytical aspects to the existing solution and to approach new analytical projects where the stability solution can serve as a reference.
Is this solution a product or can a customer bring in its own ideas regarding processes and requirements?
Simon Kamprath: The solution is not a product but based on common software products that are configured and customized according to the requirements of the customers.
If I want to learn more, is it possible to see a demo? Can I get in touch with the StatSoft experts?
Simon Kamprath: Of course! We know from experience that it is very difficult to explain solutions like this and deliver the information so that customers can come to a decision.
That’s why we believe that a discussion with our experts, potentially including a demo is a very important step. We are looking forward to prospect getting in touch!
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StatSoft is your trusted partner for analytical solutions in pharmaceutical manufacturing, QA and reporting.
Reach out to us and let’s talk about what we can build together!
