Faster Development and Compliance
May 18, 2020

5 Must-Haves For Faster Development and Compliance

Traceability

Compliance is critical to many industries, like medical device and automotive development. If you use a manual process to prove compliance, you could be slowing the entire operation. Which means it’s taking longer to get your quality products to market.

However, if you automate time-consuming tasks with the right tool, you’re not just getting work done faster. You’re ensuring accuracy — and confidence in proving compliance.

What kind of tool does this?

 

Linking Project Artifacts is Key

Yes, we’re talking about traceability. Compliance demands that you trace every relationship and artifact change all the way back to the original requirement. Manually creating a trace matrix can be painstaking and risky.

If you don’t currently automate traceability, doing so can dramatically speed your development and compliance.

Learn how Fractyl received the CE Mark 12 months ahead of schedule >>

 

Traceability Musts for Application Development

Not every traceability solution is the same. If you’re going to invest in a tool, you need to drive real improvement. Here are 5 key components of traceability for improved business results:

1. Requirements Management + Dynamic Linking

Any traceability solution should provide requirements management and easily link all artifacts. Beyond that, it should also give you various kinds of links.

At its most basic, links must let you go forwards and backwards throughout the process. You should see all related information all the way back to the original requirement.

But you should also be able to create links that:

  • Deliver impact analysis.
  • Provide gap and risk analysis.
  • Allow multiple relationships across requirement documents.
  • Verify associated test cases.
  • Prove that risk is identified and mitigated during early development.

There are tools which capture the granular details of each link, making it easy to quickly understand the purpose of each.

Your solution should be configurable to the types of links you want or need to report against. Read common product development links >>

2. Automate Manual Processes

If you’ve been manually tracking actions for compliance, you don’t need us to tell you what a challenge it is. There are a lot of activities happening in sequence and in unison, and human error is a real possibility.

By automating processes, you recoup all the time you used to spend:

  • Capturing required data.
  • Sharing data.
  • Guiding users to next steps.
  • Sending notifications.
  • Escalating items so they don’t go unnoticed.
  • Notifying team members of changes or project failure.

What’s more, automation doesn’t forget steps, and it doesn’t misplace data.

>> You are also able to automate code reviews by using static analyzers, like Helix QAC and Klocwork.

3. Complete Visibility

If your data is buried in documents, spreadsheets, or other sources stored in multiple places, you don’t have complete visibility. It’s difficult to ensure everyone is kept informed of the project status, and you may not know if you’re working off the most current version of the data. 

The best way to solve this is to use a single platform for all your development artifacts. This gives you instant visibility — and the ability to quickly organize, analyze, and display data.

4. Configurable Reporting

Your reporting needs can change over time. And the kind of reports you need to provide change depending on who requests them.

For example, external requests may relate to audits or product submissions. Internal audiences might be more interested in daily status updates, the cost of a particular change, and other progress reports.

Choosing a solution with flexible reporting will not just provide these reports in an instant — but also let you configure reports to present data in a clear and meaningful way. 

5. Needs-Based Security

Compliance hinges on the ability to protect who can access what information, and who can make changes.

Your traceability solution should cover your security needs with:

  • Strong field-level security to manage records and events.
  • The ability to restrict users’ ability to view, add, and edit data. 
  • Process-based controls to ensure decisions are made by appropriate stakeholders.
  • Control over access rights for contractors and third parties.
  • Electronic signatures.

As compliance becomes more complicated, like with the introduction of EU MDR, it’s vital that you’re able to meet the security requirements outlined in the regulations that apply to you.

For examples, and a deeper dive into how integrated traceability gives you faster compliance, download this white paper >>

 

Requirement Management Software With Solid Traceability

If you’re ready to research solutions that provide all of the above, look into Helix ALM. It’s consistently chosen to make compliance easier with its:

  • Ability to handle requirements, testing, and issues in a single platform.
  • End-to-end traceability.
  • Highly configurable workflow.
  • Integration with popular tools, like Jira.
  • Security and electronic signatures compliant with regulations like 21 CFR Part 11.

You’re welcome to try Helix ALM free for 30 days. Compare it against other tools. And watch a recorded demo on your time to see how it all works.

Start Tracing for Free    Watch a demo