A New Approach to Delivering Bespoke Software Solutions to the Regulated Sector

Like all manufacturers, companies in regulated sectors must innovate and improve their manufacturing processes to remain competitive. Driving efficiencies and increasing productivity levels are ongoing objectives.

In addition to this drive to remain competitive, manufacturers in regulated industries must deal with the added burden of compliance. Also, requirements in many heavily regulated industries are changing as governments around the world, particularly in the USA and EU, raise standards.

Prime examples of this are the pharmaceutical and medical device manufacturing industries where new regulations aim to improve product quality and traceability. The latter has multiple aims including combating the trade in fake and stolen medicines as well as improving quality of service for patients and consumers.

The Traditional Approach to Delivering Bespoke Software Solutions

So, there is a need to improve and innovate production lines while also meeting new and existing regulatory requirements. In many cases, this involves the introduction of new software solutions. Examples include:

  • Integrating machines and automating processes
  • Collecting and making better use of data
  • Adapting production lines in preparation for new business opportunities
  • NPIs
  • Updating validation procedures
  • And more

In the past, the development, testing, and implementation of these software solutions followed a similar path. The core of this development path typically involved a software solution provider starting with a blank screen.

Of course, most software solution providers serving the manufacturing sector will have specific sections of tested and trusted code they can adapt and re-use on multiple projects. If the project is to deliver a bespoke software solution, however, providers will write most of the code from scratch.

There are lots of benefits to this approach, not least that you will end up with a highly customised software solution that meets your specific needs and objectives.

There are downsides as well, however:

  • Project time – starting from scratch is the longest approach to developing a new software solution
  • Project cost – as the project will take longer, costs will be higher too
  • Longer testing and debugging time – as bugs always exist in new code, there is no way to be sure the software will be fully ready for all situations and outcomes, regardless of the extent and quality of testing it has gone through

We know all the above at SL Controls because we have extensive experience developing fully bespoke – and often highly specialised – software solutions for the manufacturing industry. Plus, we have specific experience developing those solutions for manufacturers in regulated industries.

Sometimes, this approach is unavoidable, i.e. starting from what is essentially a blank screen is the only way to deliver on the client’s requirements. However, this is not always the case.

Therefore, we knew there was an alternative approach to developing bespoke software solutions for manufacturers in regulated sectors that would be suitable for a wide range of situations.

So, we built it.

The SL Controls New and Unique Approach to Software Development

The new approach we developed at SL Controls has three main objectives:

  1. Deliver the same level of quality, versatility, flexibility, and scalability as a software solution written from scratch
  2. Meet the promise of being a bespoke software solution by being fully customisable
  3. Reduce project delivery times and costs

We achieved this by taking a modular approach to the most typical software requirements that manufacturing sectors require. This involved breaking those typical software solutions into commonly needed components.

We then fully developed and tested the code for those components and packaged them in a module. This gave us multiple modules that, when put together, created an end-to-end software solution.

Furthermore, we didn’t lock down each module in a take-it-or-leave-it-type situation. Instead, we built the modules so each one could be individually modified and customised.

TOTALline – Improving Manufacturing Processes in Regulated Sectors

The result of the efforts above is the TOTALline product range. With TOTALline, clients can:

  • Select (and only pay for) the modules they need – there are 14 modules to choose from
  • Get all or some of those modules customised to better meet their requirements

In other words, creating bespoke software solutions from scratch is no longer required in many situations. Examples include automating batch record-keeping and traceability, automating batch changeovers, integrating production line equipment, and data collection and reporting.

Where TOTALline is a suitable software solution, you will save considerable time and money, dramatically improving return on investment. Find out more today.

Shane McLaughlin

Shane is SL Controls’ Business Development Manager and has extensive experience and a demonstrated history of working in the regulated automation industry. His areas of expertise include Verification and Validation (V&V), Process Control/Monitoring, Medical Devices, Pharmaceutical, Bio Pharma, Failure Mode and Effects Analysis, and systems engineering. He also has experience leading technical teams and delivering to demanding schedules.

View all posts by Shane McLaughlin