Based on our customers’ experience, combining Agility and Compliance is possible… more than this, Agility is essential! Agility is actually the key for manufacturers who want to stay in the race: it allows them to align both the hardware and software teams, to be more innovative, responsive to the market and also enables teams to implement a continuous compliance strategy. In this article, we are focusing on two crucial business benefits that agile approaches can provide for manufacturers. Let’s see why agile developments are suitable for standards requirements.

With more and more instability, uncertainty and complexity whatever the sector, industrial companies are evolving in difficult, very competitive and continuously changing environments. These organizations have to follow and adapt to customer expectations, to the evolution of both European and International regulations (i.e. ISO, ISO 13485, IEC, IEC 62304, ASPICE, CMMI, IPAA…) and to emerging technologies. Enterprises see it clear now: software is at the very heart of it all; it’s the cornerstone, what brings value.

To deal with this tidal wave of changes, organizations have to come up with a new way of innovating. It is necessary to find a solution enabling to continuously adapt software developments to meet both customer demand and requirements as to be standard compliant, which is a sine-qua-non condition to launch (and keep selling) products.

When discussing with our prospects, we realize how many industrial companies still consider that the most reliable method to get their software products certification is the traditional V-model. However, there’s an emerging awareness concerning the use of agile approaches: little by little, they are proving the benefits they can provide, and this, not only for the IT department but also for software development teams. Actually, working in an agile enterprise comes with multiple advantages not only for customers but also for suppliers and employees.

Agility’s 2 major benefits for industrial manufacturing companies

As seen before, industrial companies are under pressure to deliver reliable, functional, safe and quality products… and all this within a short period of time. Far from imposing as the magic formula, here is how agile methods enables manufacturers to meet their challenges.

Shorten development cycles to accelerate the time-to-market

Agility advocates shorter developments, hence divided into several parts and carried out in fast iterative cycles. This way, working incrementally increases the value of the end product, capitalizing earlier on user feedback and gaining more control over the overall product. Thanks to its iterative approach, agility makes it possible to create a minimum viable product (MVP) that can be quickly ready to be delivered to market. In highly competitive sectors, accelerating the time-to-market gives the business a competitive edge as it enables to deliver a software product before potential competitors.

Increase product value while reducing risk

One of the key objectives of agility is to deliver high-value features quickly and regularly. This is the first principle of the Agile Manifesto. Differently from traditional management – aka Waterfall (or V-model) – agile methods are result-oriented: they aim to focus on value delivery as to rapidly adapt to and meet the changing needs of the end user, who is often volatile. Furthermore, agility helps identify potential defects from the very first development stages, hence reducing the risk of errors and therefore maintenance costs.
Moreover, by providing effective risk management, agility comes with greater reactivity in case of non-compliance, opportunities to modernize any service concerned as well as user-friendly methods.

Succeed in passing a Compliance Audit while developing in Agile

It is commonly assumed that agile methods and standard compliance are not compatible. False! Why? Because a standard only defines the objectives to be met throughout the software lifecycle through the implementation of a set of activities. Then, it is up to each organization (or team) to set up its processes, methods and tools to achieve these objectives.

Actually, the real question is how does agility help facilitate regulatory compliance?

Agility brings a series of good practices for a comprehensive, efficient management throughout the entire software development process with a rigorous Software Quality Assurance plan.

During an audit, the most important thing is to be able to prove that the risk is under control. Agile methods promote the implementation of a Quality Management System (QMS), a Software Quality Assurance Plan and also Risk and Defect Management.

Moreover, agility encourages information sharing and alignement among the stakeholders involved in the software project, enhancing transparency at all levels. The end product is delivered in smaller packages, rather than in a big final version. Thanks to incremental tests and automation, agile methods provide higher reactivity in case of non-conformity while also letting the possibility to make quick adjustments.
Ultimately, thanks to the use of appropriate tools, these good practices bring more traceability from the very beginning of the development to product delivery.

As a consequence, organizations can be more confident during compliance audits, whose certification process becomes easier and faster to pass. Result? The sooner your products are compliant, the sooner you can deliver them to market. In other words, a time-saver that can pay off handsomely.

In a nutshell, the key message of this article is that combining agile developments and compliance to standards is possible and even recommended! It is in your best interest to start an agile transition if you haven’t done it yet or else, if you have already brought agility in your organization, to strengthen it. The success of your business relies on it. Big plus, by implementing Agile good practices, you will also succeed in terms of standards compliance.

ℹ️ If you are interested to go further, you should know that implementing the right agile tool can’t but help you succeed in your transition and achieve your compliance goals. But how to be sure to make a good choice actually? In a complementary article, we are sharing you the key features of a top Application Lifecycle Management (ALM) tool to look for.

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