All "Compliance" articles

How to build a complaint management system

You know what’s more dreadful than receiving a customer complaint? Being asked by a regulatory auditor how you handled the complaint and if you ...

A step-by-step guide to internal quality audits

Gearing up for a quality audit is no small feat. Whether it’s your organization’s first time being audited or the 100th, there’s always room for ...

The ultimate guide to change control for life sciences companies

For any organization that makes a product, it's important to have change controls in place, but what are change controls? How do they differ from ...

What are the types of quality audits?

Audits. If you work in life sciences, you know that quality audits are a part of creating life changing products. Though all quality audits aim to ...

21 CFR Part 11: Compliance in the supply chain [Checklist]

21 CFR Part 11 applies to any official quality or manufacturing records pertaining to the design, development, or manufacture of a drug or device ...

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 ...
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