The life sciences industry is up against some incredibly high standards from regulatory agencies worldwide – with good reason – so it makes sense that we, in turn, have incredibly high expectations of our vendors, especially IT. Because we have to be able to show complete traceability in our work, we need our software vendors to do the same. And, if they can’t, they don’t get to play with us.
From the perspective of a software vendor, our industry demands can be rather daunting. A lot of software development is fast-paced, organic, and ever-evolving, which we tend to love in our personal lives. But, when it comes to the health and safety of the patients we serve, we need a much slower, more thoughtful, heavily tested, and – above all – clearly documented approach.
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So, how can software vendors survive our frightening gauntlet and break into the life sciences industry? Here are a few steps to get started:
- Understand and accept that we care a great deal about documentation. “If it’s not documented, it didn’t happen.” This is a basic tenet of our industry. And, this doesn’t just mean jotting something down after the fact. For us, this means first documenting how you plan to do things, then documenting proof that you did them, and finally documenting the outcome of what you did.
- Hire a highly-regarded industry expert to assess your product and your documentation. This is not the kind of thing you can do on your own. The regulations are abundant and densely written with lots of room for interpretation. Without hands-on experience applying the regulations in real life, you will be hard-pressed to accurately assess your own situation and identify the gaps.
- Follow the recommendations provided by the expert. It may seem like overkill compared to the way you’re used to operating, but life sciences is a unique space, and it’s important that you trust the expert (so, choose wisely!). Keep in mind that some of the recommendations could be expensive and time-consuming, like writing new standard operating procedures (SOPs) and adding new functionality to your product. But, implementing the changes is what will allow you to be taken seriously by clients.
- Partner with a service provider who is already in the industry. Once your product and documentation are up-to-snuff, you’ll probably still need some help before you land your first few clients. Life sciences organizations are VERY reluctant to be the first adopters of new technology, so you should consider partnering with a service provider – an expert in computer systems validation (CSV) – who already works in the space, is able to quell any fears clients have about trying something new, and is willing to vouch for you and your product.
Are you a software vendor interested in operating in the life sciences industry? Contact us – we’d love to help you get started.