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All "Compliance" articles

iso
• January 03, 2023

7 ways to fail an ISO audit in 2023

A common word of encouragement you'll hear from colleagues when they find out that you're facing an ISO audit: "Good luck!" Of course, luck isn't a ...
Compliance
• December 06, 2022

How to build a complaint management system

  What’s more dreadful than receiving a customer complaint? Being asked by a regulatory auditor how you handled the complaint and if you effectively ...
Compliance
• October 20, 2022

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 ...
Compliance
• October 05, 2022

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 ...
Compliance
• September 22, 2022

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 ...
Compliance
• August 30, 2022

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 ...
Compliance
• August 09, 2022

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 ...
Compliance
• August 02, 2022

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 ...
Compliance
• July 19, 2022

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 ...
Compliance
• June 24, 2022

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 ...
FDA
• April 26, 2022

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 ...
Compliance
• June 08, 2021

How to ensure your quality management system processes and procedures are compliant in 2023

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 ...
Pharmaceutical
• May 11, 2021

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 ...
Compliance
• May 04, 2021

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 ...
Updates
• February 01, 2021

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 ...
Compliance
• November 10, 2020

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 ...
Compliance
• October 13, 2020

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 ...
Compliance
• July 14, 2020

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 ...
Compliance
• March 12, 2020

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 ...
Medical Devices
• February 13, 2020

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 Devices
• February 06, 2020

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 ...
Compliance
• January 07, 2020

Medical Device Compliance Consulting: 11 Questions to Ask Before Hiring

The FDA will send out three 483 observation letters today — will one of them be going to you? The process you have to go through to bring a medical ...
Medical Devices
• November 19, 2019

5 Common Medical Device Regulatory Compliance Problems Faced in 2020

Is the thought of achieving and maintaining regulatory compliance stressing you out? It's a good thing that our friends in the pharmaceutical ...
Compliance
• October 15, 2019

5 Medical Device Compliance Problems That Can Permanently Damage Life Sciences Companies

Medical devices have been responsible for more than 80,000 deaths since 2008, according to STAT. The total number of complications resulting from ...
Compliance
• August 27, 2019

ISO Compliance: The What, Why, and How for Life Sciences Companies

As a life sciences company, you play a major role in the overall global economy. Your products can be quite literally life-changing for the people ...
Compliance
• August 20, 2019

Why Did Medical Device FDA 483 Observations Drop 6.2% Last Year?

In 2018, the FDA issued 124 fewer 483 observation letters to medical device companies than they did the previous year. In 2017, there were a total of ...
eQMS
• August 01, 2019

How to Enable Quality Controls in Life Sciences Marketing

Most life sciences companies are aware of the dangers of marketing noncompliance on their products. In recent years, major pharmaceutical ...
Compliance
• April 09, 2019

Quality vs. Compliance: These 5 Questions Will Determine Your Focus

What is Quality v Compliance? Have you ever recommended a restaurant based on their lack of health violations? Listen to the audio version of this ...
eQMS
• March 14, 2019

What You Need To Know About Part 11 Compliant Document Management Systems? (Top 4 Providers)

If your company is in a highly regulated industry—including pharma, medical devices, biotech, biologics, or CROs—you have to decide how to approach ...
eQMS
• January 03, 2019

Understanding the Growing Need for Product Compliance Software

The life sciences industry is under an incredible amount of pressure from regulatory authorities, patients, and market conditions. Regulatory ...
Pharmaceutical
• December 18, 2018

Essential Tools to Achieve Compliance in the Pharmaceutical Industry

Data integrity was a crucial trend in warning letters issued by the FDA last year, along with a significant increase in international inspections. ...
Pharmaceutical
• December 12, 2018

The Key to Future-Proofing Pharma Compliance

Many organizations take a reactive approach to compliance management. This means corrective action isn't taken until the organization is facing an ...
Medical Devices
• November 13, 2016

9 Ways to Ensure Medical Product Compliance Through Quality

In our work with medical device product developers and manufacturers, we know quite well the stress that comes with scrutiny of regulatory ...
iso9001
• September 28, 2016

5 Ways that a QMS Improves ISO 9001 Management

A Quality Roadmap for Therapeutics Developers, Medical Device Companies and Contract Manufacturers
Compliance
• September 01, 2016

Too Late for a QMS: Theranos' Ignoring FDA Compliance Will Cost it Billions

Theranos, the once-hot clinical testing start-up, has taken a beating in the press recently. With almost $700 million in venture funding and ...
eQMS
• November 18, 2014

If it’s not documented, it didn’t happen

 
Document Control
• April 28, 2014

Failure to Comply - Document Control in a Regulated Industry

It is not possible to overstate the importance of effective document control in a highly regulated industry such as medical devices. Those of you ...