Medical laboratories play a vital role in healthcare, providing essential testing and diagnostic services that guide medical decisions and treatment. But errors or inaccuracies in lab testing can have severe consequences for patients and care providers. ISO 15189 is an international standard developed specifically for medical laboratories to promote accuracy, quality, and reliability in their…
The ISO 13485 audit, also known as the certification audit, is a crucial step towards ensuring that medical devices meet regulatory requirements and international standards. Understanding ISO 13485 audit and its significance is essential for all stakeholders in the industry. In this blog, we will provide you with a comprehensive guide to ISO 13485 audit,…
The pharmaceutical industry is one of the most regulated and scrutinized sectors in the world. The quality and safety of pharmaceutical products are vital for protecting and promoting public health, as well as for ensuring consumer trust and confidence. However, achieving and maintaining high standards of quality and safety is not an easy task. It…
If you work in the manufacturing industry, you know how important it is to maintain accurate and detailed batch records. But have you ever considered using electronic batch records? This ultimate guide will cover everything you need to know about electronic batch records and how they can revolutionize your manufacturing processes. We will start by…
Are you in the pharmaceutical or healthcare industry? If so, you know how important it is to stay audit-ready and comply with FDA regulations. Specifically, 21 CFR Part 11 compliance is crucial for electronic records and signatures. In this blog, we have compiled a comprehensive checklist that you can download and follow to ensure your…