For 10 years of my life, before founding InnovX with Scott McGrail, best of friend and business partner, I was responsible for designing technological solutions from a business standpoint, aka the product vision. This was a very interesting job, with very interesting people. Friends for life. At the beginning of those developing years, we were a brady bunch of consultants. We went from project to project with fuzzy focus, but it took a turn when we realized most of our clients had similar needs: They all needed to build a foundation to manage electronic files more efficiently. This was a huge shift at the time and our service-oriented consulting company therefore became a product oriented one. A software development company.
At a certain level, building software efficiently is not so different than building any product. It’s all about understanding the constraints that you must work within, clearly defining what you want to accomplish, and optimizing where and when you can. If your business is building software for the Life Sciences industry, InnovX can help.
Our team understands the life sciences industry (pharma, med device, laboratory, clinical research, you name it!), and can navigate this regulatory landscape. This is not an expertise you will typically find on a lean dev ops team, which is a shame. Designing and building a product efficiently and effectively, as stated above, involves understanding the constraints it is subject to. An interesting fact is that a large portion of critical system requirements for regulated industries such as life sciences, is rooted in laws and good practices. That's where your regulatory expert comes in. If you are developing software with the hope of selling it to the life science industry, you must understand the regulations your would-be customers are subject to.
G-X-what?
If you’ve never heard of GxP and want to sell your products to the life sciences industry, you may want to better manage your expectations. Until you can demonstrate that your system meets regulatory requirements, you will not be able to sell it. Well, you can try selling it, but no one will buy it, which is even worse… If you cannot bring confidence that your system will be easy to validate for GxP use, your products will present too much risk to safely adopt. Nice try, but no cigar.
In previous blogs, we explained which key regulations are required by life sciences organizations to validate their computerized systems. (By the way, computer system validation, also known as CSV, is a concept any software vendor working in the life sciences industry must know.) In another blog, we also explained how 21 CFR Part 11, a core piece of law, could be interpreted from both the software vendor and the end-user perspective, and that systems could not be “pre-validated” by a vendor, another important regulatory implication you might be interested by. This is the tip of the iceberg as it takes years of working within this regulatory landscape to apply it correctly.
If you are a software vendor wanting to have resounding success in the life sciences industry, do not go at it alone. Find yourself a regulatory partner to fine tune your product roadmap and your value proposition. Find a team of experts that can tool up your product and your team to hit the regulated market you wish to reach.
We have done this work for others, and for ourselves. We would be honored to support you. If you want to know more, it will be our pleasure to discuss with you and share our knowledge. To do this, click here to schedule a free consultation or contact us directly at info@innnovx.org .
Frederic Landry
Chief Executive Officer (CEO) at InnovX Solutions
Frederic Landry has a successful track record in regulated industries, supporting product development, information technology, manufacturing, supply chain, and operations management. Through the combination of his experience and his passion for innovation, he is well positioned to help businesses of all sizes reach their full potential. When not in the office, you are most likely to find Frederic on a ski hill enjoying the outdoors. This Is the Way.
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