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Marrying Agile and Compliance in Regulated Product Delivery

compliance-2Competition is forcing safety-critical developers to deliver products quickly, while an evolving GRC (Governance, Risk Management and Compliance) environment requires that they remain audit-ready and focus on regulations at all times. Is Agile the key to achieving this twofold goal?

In sectors the medtech development, automotive systems engineering, aviation product development and others, the costs of compliance are growing – but so are the costs of non-compliance. Failing to comply with regulations can delay a product’s release in a highly competitive market. It can also have grave legal and financial consequences once the product is on the market. Any disasters resulting from poor risk management will greatly harm the company’s reputation.

Related reading:

Ovum White Paper: Agile + DevOps ALM in Regulated Safety-critical Development

Safety-critical product innovators are finding that in addition to accelerating development, Agile strategies can also help in achieving compliance with relevant regulations. But how do you align Agile with the special requirements present in regulated industries? We’re sharing some fundamental best practices below.

Why use Agile in a regulated setting?

Faster time to market is generally considered the primary value of applying an Agile approach in software delivery. In regulated industries, however, Agile has further benefits that are often not fully considered or understood:

  • Better data governance & communication: Agile requires collaboration and the efficient sharing of information across teams and disciplines. So does effective compliance management. In an Agile organization, data cannot exist in silos, and teams need access to granular, up to date, consistent, and complete information about product specifications, regulatory requirements, testing data, etc. Therefore, Agile lends itself well to regulated product development, provided that a central development & GRC hub is established. Supported by the adequate tool infrastructure and reliable documentation processes, such a shared data hub can greatly help Agile delivery and compliance at the same time.
  • Adapting to change, including changing regulatory requirements: In a fast-evolving regulatory landscape, the importance of adapting to change cannot be overstated. Consider, for instance, the delivery of a piece of digital medical technology, the design and engineering of which generally takes years. As regulators work to catch up with high-tech innovation, there’s a high chance that applicable regulations will change before the product is released. Adapting to this changing regulatory environment is crucial, and Waterfall simply cannot do that in an efficient way.
  • Process automation to reduce the chance of manual error: Successful Agile practitioners apply process automation wherever they can. Again, this stems from basic Agile principles, but has added benefits in a regulated setting because it lowers the chance of human error.
  • Avoiding overdelivery: Again, a fundamental Agile principle is simplicity: as the Manifesto says, “the art of maximizing the amount of work not done is essential.” Developing safety-critical products is costly because of all the compliance expertise, process control, and monitoring involved. Agile helps streamline and automate workflows where possible (including QA & compliance processes) to save resources.

Fusing Agile and regulatory requirements

Relying on the following best practices will help make sure that going Agile helps rather than hinders quality control and compliance.

Watch our webinar recordings:

Intland Software’s Roundtable Discussion: Agile in Medical Technology

Accurately define compliance requirements

Have your Business Analysts and Product Owners work together to analyze regulations and define compliance requirements so that both developers and testers understand them. Help the dev team decipher what compliance requirements mean in the case of specific product requirements, and build the compliance approach into their thinking from the get-go.

Map and streamline processes

Gather the input of all relevant stakeholders when mapping current processes and designing streamlined Agile workflows (where applicable). This applies to compliance and audit preparation processes as well, where there may be huge potential to save time and effort costs. Carefully analyze compliance requirements, and only apply maximum rigour where necessary.

Digitally integrate systematic risk management into your workflows

Rigorously controlling and automating design & engineering processes enables you to build risk management into the product development lifecycle. This way, risk and compliance management can keep pace with Agile iterations. In fact, some companies make risk management their primary focus, and only use compliance requirements to guide those efforts. This helps prepare for changing regulations down the line.

Practice real-time compliance monitoring

Using Agile in safety-critical product delivery requires adequate tooling support. Having all that data in one platform also provides opportunity for adequate monitoring. Build reports and analyze data and documentation to make sure you stay compliant. Continuous compliance reduces audit preparation time and resource needs, and can help eliminate the risk of delays due to regulatory issues.

Automate workflows

This one may be applied to all the above: rely on process automation to rule out the chance of manual errors that could jeopardize compiance. Automate documentation. Automate traceability. Automate monitoring & reporting. All of these are key to regulatory compliance, and will help cut costs.

Interested in industry-specific best practices?

Agile + IEC 62304: Using Agile in Medical Device Development

Agile + ISO 26262: Adopting Agile in Automotive Development

These are just some of the fundamental best practices of applying the Agile approach in safety-critical product delivery. Overall, it’s clear that Agile can provide great advantages in navigating an evolving regulatory landscape. But due to its very nature, Agile requires thoughtful adaptation and careful process mapping when used in regulated industries.