Challenges with Compliance

The life sciences industry is heavily regulated. That means that all life sciences organizations — medical device manufacturers, healthcare providers, and pharmaceutical companies — need to be compliant. 

But it's challenging to achieve compliance. 

Regulations change. Keeping your team up-to-date on the latest compliance requirements is tough — especially if you're working in siloed documents.

Creating a traceability matrix to prove compliance is typically a manual process. (And too many organizations wait until a project is completed to create that traceability matrix, which makes it all the more difficult.)

You can meet these challenges head-on.

Life sciences compliance software will help you share information across teams and automatically create a traceability matrix as you go. Watch the video below to learn more. 

How to Achieve Regulatory Compliance

There are many regulatory compliance standards that life sciences organizations need to meet.

FDA. ISO. HIPAA. EU. IEC. SOX. 

Which ones apply to you will depend on what type of life sciences product you're producing — and where. Some common regulatory compliance standards to be aware of include 21 CFR Part 11, IEC 62304 and 60601, ISO 14971 and 13485, and cGMP.

Using life sciences compliance software — like Helix ALM from Perforce — will help you meet these standards. 

6 Benefits of Life Science Compliance Software

Achieving compliance helps life sciences organizations stay competitive, increase productivity, and deliver quality products.

Helix ALM makes life sciences compliance easy.

Mitigate Risk

You'll be able to mitigate and manage risk throughout the development process. That's because you'll get full audit trails and instant insight into issues.

Gain Visibility

Improve visibility into your development process. Keeping your teams up-to-date on requirements documents and testing statuses is easy. 

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Boost Productivity

Help your teams work together more efficiently. You'll be able to coordinate design changes across engineering teams quickly. And you can check on project progress and accurately forecast schedules. 

benefits-traceability

Trace Instantly

You'll be able to trace requirements, tests, and issues instantly. This makes creating a traceability matrix much easier. 

Be Compliant

Show regulatory bodies how you've achieved compliance. You'll automatically create an audit trail that shows how you've met requirements, tested them, and resolved bugs. 

Secure Information

Keep all of your development artifacts locked down and secure. This helps you stay compliant. 

See How Helix ALM Simplifies Compliance

See why leading life sciences companies rely on Helix ALM to manage their core processes, drive innovation, and gain a competitive edge.

Trusted by Leaders in the Life Science Industry

 

From Word Docs to Life Sciences Compliance

How Fractyl Achieved CE Certification in Record Time

Fractyl — a clinical-stage medical technology company — used to manage requirements in Microsoft Word documents. That made it hard to comply with regulations. 

But when they implemented Helix ALM, they received a CE Mark for their innovative Revita™ procedure — twelve months ahead of schedule. 

Watch this webinar to hear from Ann Rossi, Senior Software Quality Assurance Manager of Fractyl Laboratories. 

You'll learn: 

  • What they needed for compliance.
  • Why Word docs and Jira issues weren't enough.
  • How Helix ALM made life sciences compliance easy.

Try Helix ALM Today

Try Helix ALM free for 30 days. You'll see for yourself how easy it can be to prove life sciences compliance. 

See Helix ALM in Action

Sign up for our next live demo of Helix ALM.

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