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.
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.
- 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.
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Sign up for our next live demo of Helix ALM.
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