Blog

Your definitive guide to 21 CFR Part 820

We break down what 21 CFR part 820 is, what it’s for and how medical device companies are expected to comply with this key regulations.

22 feedback quotes for 2022

From Brene Brown and Steve Jobs to Little Simz and the Dalai Lama! 22 quotes on the art of feedback will inspire you.

IPO trends Q1 2024

Read our insights blog to find out more about the IPO trends from the first quarter of 2025.

How to respond to an RFP and win over prospective clients

Follow our 8 red-hot tips to make your response stand out and show prospective clients that you’re the right choice for them.

Where does the CAPA process fit into your quality management system?

Find out where the CAPA process fits into your quality management system and the 7 key steps involved in gaining better efficiency.

What is AS9100?

A quick guide to the AS9100 standard for the aerospace industry, how it’s different from ISO 9001 and what you need to do to comply.

The essential link between corporate governance and internal audit

Effective corporate governance and internal audit are vital to one another. In this blog we explore this link and the importance of them both. Learn more.

How AI can boost efficiencies in your quality management system

Learn how you can resolve manufacturing issues and boost overall efficiency with AI, helping you to maintain compliance and make the most of your resources.

What is FDA 21 CFR Part 11 European Equivalent?

Annex 11 & FDA 21 CFR are two resources available to regulated life-science professionals regarding the validation of computer systems. Learn more.

Analytics in healthcare: What is it and why is it important?

Learn about healthcare analytics, the 6 key benefits of it and why it’s so important for healthcare organisations to stick to a patient centered approach.

Internal audit and fraud prevention: Are you providing the right assurance?

Internal audit and fraud prevention. Is it the duty of internal auditors or senior management as the first line of defence? Learn more.

GAMP 5 guidelines and the FDA’s CSA guidance: their necessity and the case for quality

Access a summary of our recent whitepaper on the case for quality and the necessity of GAMP5 2nd Ed. and the FDA’s CSA guidance. Read the blog for more.

Auditor changes roundup: Q4 2023

Find out more about auditor changes in Q4 2023. Overall, there were 157 new engagements during Q4 2023.

Is there a mental health at work act?

Read our blog to answer the question ‘is there a mental health at work act?’ and find out the legislation that relates to mental health at work.

2023 IPOs: annual market share and analysis

2023 IPO market analysis: Traditional IPOs surge, SPACs cool down. Discover top performers, average deal sizes and leading auditors. Read more.

Auditor changes roundup: Q2 2023

We review the stats for auditor changes for Q2 of 2023, spotlighting on the top SEC companies. Read the blog for the latest insights.

Transfer agent market share – 2021

A transfer agent is assigned by a corporation with publicly traded securities to track individuals that own their stocks and bonds.

Unraveling safety performance: incident rate benchmarking

How does a company know whether they have a good safety record? Find out how to benchmark and calculate incident rates to gauge safety performance.

Quality management: The key to building brand trust

Discover how quality management fosters trust with stakeholders, enhances operational excellence and safeguards data in the findings from our report.

What is EMA Policy 70?: Unlocking transparency in medicine

Discover the objectives, scope and impact of EMA Policy 70 and how it shapes the future of medicine. Click through to find out more.