It has become extremely common for organizations of all sizes to look to cost management by relying on open-source software or coding platforms for multivariate data analysis and process control.
While there are definitely upsides to using these platforms there are also some risks associated that should not be underestimated.
- What happens when your developer leaves?
- Have you set up your SOPs to manage the systems?
- Are the personnel in place that can continue to maintain the software and more importantly upgrade when needs or hardware internally changes?
Below are some other variables that KAX Group would consider critical to take into consideration and if not addressed, can have a significant impact on your business.
Validation and Compliance:
Ensuring that open-source tools meet Good Manufacturing Practice (GMP) standards can be challenging. These tools can often lack the formal validation and documentation required for regulatory compliance. When working in pharmaceutical development, drug discovery, food manufacturing and the agricultural sector validation is at the core of the business and is a non-negotiable for the successful development, manufacturing and quality control of final manufactured product.
Support and Maintenance:
Open-source software typically relies on community support, which may not be sufficient for critical applications in regulated environments such as pharmaceutical applications. This can lead to delays in addressing bugs or implementing necessary updates. In addition not knowing when an issue may be addressed can lead to uncertainty and time delays that are not acceptable in manufacturing processes or if the implementation is at a critical milestone in your R&D or research project.
Security Concerns:
Open-source software can be more vulnerable to security risks if not properly managed. Regular updates and patches are essential, but the responsibility falls on the end user to ensure these are applied. There are no claims or legal obligations for open source software around cyber security. Often developers are code writers and not security experts leaving a potentially big and dangerous gap in your conformance protocols.
Lack of Standardization:
Open-source tools may not adhere to industry standards, leading to inconsistencies in data analysis and reporting. This can be problematic in environments where standardization is crucial .
Integration Issues:
Integrating open-source tools with existing proprietary systems can be complex and may require additional customization, which can be time-consuming and costly .
Documentation and Training:
We already mentioned SOPs around system management but comprehensive documentation and training resources may be limited compared to commercial software, this makes it harder for users to fully leverage the capabilities of open-source tools.
Perhaps this is a great example of the old saying “you get what you pay for”. When looking at our users and listening to their experiences of both open source and proprietary MVDA software we focused on developing a platform that was at a reasonable price point for all users, a perpetual license model for organizations and a tailored subscription model for Academia as we strongly believe in supporting future MVA and chemometricians and their exceptional research programs, coming through research institutions worldwide.
If you are working on a project, have some questions about KAX Group or just want to talk all things MVDA and Process Analytics feel free to connect on LinkedIn with Brad Swarbrick or Joon sup Lee.
