As automation, machine learning, sensor technologies, remote monitoring, artificial intelligence, etc advance, manufacturing companies increasingly rely on bespoke software solutions to achieve their objectives. This includes both fully bespoke solutions and software that is customised according to your requirements.
Delivering this type of tailored software to the regulated sector – such as to pharmaceutical or medical device manufacturers – is very different from developing bespoke software for companies in other industries.
Achieving Client Objectives
As with other companies in other industries, software solutions developed for the regulated sector must deliver on client business objectives. This includes:
- Making productivity gains and efficiency savings
- Improving OEE (overall equipment effectiveness)
- Enhancing capacity
- Reducing costs (in relation to maintenance, production, etc)
- Extending capabilities
- And more
However, software solutions developed for the regulated sector must also comply with regulations.
In addition, the regulated sector often also requires software solutions where the primary purpose is compliance with regulations, both new and existing.
A recent example in the pharmaceuticals industry was the introduction of the Falsified Medicines Directive (FMD). Many companies required new software solutions to, for example, adhere to the serialisation requirements of that directive.
Another ongoing example is the introduction of the new EU Medical Device Regulations (MDR). Serialisation of medical device products is a key component of the new MDR, with manufacturers turning to bespoke software as the solution.
Understanding the Regulations
At SL Controls, we have extensive experience developing new, and customising existing, software solutions for pharmaceutical and MedTech industry clients. Therefore, we know the importance of having in-depth in-house knowledge of all regulations that impact our clients’ businesses, particularly those that directly relate to software. This includes 21 CFR Part 11.
This is not enough on its own, however, as the regulatory landscape constantly changes. New regulations are always either out for consultation or approaching their implementation deadline.
As a result, it’s as important to understand broader regulatory trends as it is to understand existing regulations. This helps ensure software solutions are adaptable, flexible, scalable, and future proof.
Beyond the Regulations
While regulations are an important part of your business if you are in a regulated industry like MedTech or pharmaceuticals, they are still only a part. Therefore, successfully developing and implementing software solutions for businesses like yours means being able to do more than write code and understand regulations.
From your point of view, it’s also important you choose a software developer who understands your industry and your business, including the unique pressures, risks, challenges, and limitations you face.
This requires past experience of similar projects. From this experience, software development teams can build an extensive in-house knowledgebase. So, every lesson learned on every project improves the delivery of the next project.
With around 1.5 million engineering hours under our belt at SL Controls, we take a lot of experience and learnings into every project we work on.
Knowledge Sharing and a Learning Culture
In addition, we believe it’s important to have a strong and supported learning culture in the company. This improves skills but it also reduces the risk of information and knowledge becoming hoarded or trapped silos, i.e. where one person learns something on a project that could help future projects, but there is no structure in place for that knowledge to be shared.
At SL Controls, our learning culture, knowledge sharing structures, and past experience mean we don’t start projects for clients in the regulated sector with a blank page, figuring things out as we go. Instead, we hit the ground running, eliminating errors before they are even introduced.
From your perspective, this means your software development and capital investment projects will finish on-time and within budget while also delivering on your objectives.
To find out more about our bespoke software development capabilities at SL Controls, please contact us today.