All "Compliance" articles

21 CFR Part 11: A guide for clinical trial compliance

When conducting or managing any part of a clinical trial, from pre-study through close-out, compliance with 21 CFR Part 11 is always required. The ...

What is GxP in the life sciences industry?

In the 1990s, the drug fen-phen soared in popularity as many people used it to help with weight loss. However, the drug began to cause heart valve ...

How to choose CAPA software: 8 essential functions

Listen to the audio version of this article read by a real person here (Sound on!): In the life sciences industry, regulators require that companies ...

5 notorious compliance issues in the pharmaceutical industry

Does the prospect of getting an FDA 483 letter keep you up at night? Listen to the audio version of this article read by a real person here (Sound ...

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

Listen to the audio version of this article read by a real person here (Sound on!): It’s stressful to receive an observation or warning letter from ...

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. Listen to the ...

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 ...
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