All "Compliance" articles

5 notorious compliance issues in the pharmaceutical industry

Does the prospect of getting an FDA 483 letter keep you up at night? You’re certainly not alone. Compliance pressures in pharma have never been ...

A guide to writing Corrective and Preventive Action (CAPA) reports

It’s stressful to receive an observation or warning letter from the Food and Drug Administration for corrective and preventive action (CAPA) ...

How to ensure your quality management system processes and procedures are compliant in 2022

In a highly regulated industry like life science, you have to make sure every 'i' is dotted and every 't' is crossed. The FDA and other regulatory ...

Biopharma Quality Management: 5 Steps to Guarantee Regulatory Compliance

In recent years, the biopharmaceutical industry has experienced an onslaught of regulatory changes.  When you consider the total volume of regulatory ...

How to Prepare for and Pass an Audit – and What to Do Next

Sooner or later, every life sciences, biotech, pharma, or medical device manufacturer will face an audit. Whether that’s a pre-approval inspection, a ...

Qualio is Officially ISO 9001 Certified!

At Qualio, we’re all about helping life sciences, biotech, pharma, and medical device companies get products to market faster with our robust ...

Does an FDA Class 1 Medical Device List Exist?

Understanding where your product falls in FDA classifications can help medical device manufacturers plan for regulatory compliance. If you can find a ...

5 Major IEC 62304 Compliance Mistakes Medical Software Manufacturers Make

The international standard IEC 62304 is a standard that specifies life cycle requirements for the development of medical software. This standard is ...

A [Printable] 21 CFR Part 11 Compliance Checklist to Follow Step-by-Step

For life sciences companies, 21 CFR Part 11 compliance has always been a challenge. It requires irrefutable evidence that your organization is ...

Quality Management Initiative for Coronavirus and COVID-19

Quality Management Initiative for coronavirus and COVID-19 Starting today, we are offering our cloud Quality Management System (QMS) software and ...

14 Medical Device Quality Management System Requirements for Regulatory Compliance

Every day, three medical device quality managers open a piece of mail they will never forget. And these letters aren’t unforgettable in a good way. ...

Medical Device Quality Assurance and Regulatory Compliance in 2020: What You Should Know

Maintaining an edge means staying ahead of the competition and regulatory bodies when it comes to medical device quality assurance and regulatory ...
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