The Key to Compliance is Traceability – Would You Like to Automate it?

Automating traceability creation and maintenance supports regulatory compliance activities and thereby reduces risks.

Traceability has many benefits in product development. It is also mandatory for regulatory compliance, no matter whether you build cars, trains, planes, medical devices, industrial tech. There are very few exceptions.

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Traceability in product development is everywhere:

  • From regulatory compliance documents to your system description
  • Between user requirements and system requirements
  • Between requirements of any kind and tests
  • Traceability between risks and functions
  • … and many more

A Glossary is a First Step

Semiant, our automated quality assistant, already provides you with traceability between glossary terms and requirements. This is already useful for compliance activities:

  • Regulatory compliance requires a controlled vocabulary and a common language, which Semiant helps you establish.
  • The Glossary provides traceability between glossary term and requirements relating to the term.
  • Last, it provides traceability between terms, e.g. generalizations or associations between terms.

Risks of Not Having an up to Date Traceability

For products that require functional safety compliance, not having a sound traceability can lead to serious problems:

  • Missing or incorrect traceability can lead to a rejected audit, leading to delays in product launch and expensive rework.
  • In case of accident that involve your product, there will be an investigation. Gaps in your traceability could lead to heavy fines, even prison for executives or bankruptcy for the organization.

As an example, consider the cost of the Boeing 737-MAX disaster: Hundreds of people died, thousands of planes grounded for over a year, loss of sales, and a heavily damaged reputation. The investigation uncovered neglect of fulfilling regulatory requirements.

Would you Like to Automate Compliance Activities Related to Traceability?

Traceability is useful beyond compliance. However, creating and maintaining traceability is tedious. That’s why we are exploring how Semiant could help you with this.

We prepared a one-question survey below. We’d love to hear whether any of these ideas resonates, or whether you have even better ideas.

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Photo by JJ Ying on Unsplash