Qualityze - Blogs

A non-conformance is a deviation from your specified requirement. It means a product or process doesn't meet y...

Health Level 7 (hereinafter HL7) is a set of international standards for transferring patient data between sof...

A Quality Management System (hereinafter QMS) audit is essential for any organization that wants to ensure its...

Product recalls have become a significant concern for consumers and businesses alike. In recent years, the fre...

The post-pandemic business world is markedly different from the pre-pandemic one. Regulatory bodies have evolv...

The healthcare industry has seen rapid advancements, particularly in medical devices. However, with this growt...

Without a structured change management plan, even the smallest tweaks can lead to massive headaches—regulatory...

Electronic Quality Management Systems (eQMS) have become indispensable for companies aiming to maintain compli...

Imagine a situation where Company A designs a new medical device but outsources its manufacturing to Company B...

Corrective and Preventive Action (hereinafter CAPA) is indispensable to a robust and modern Quality Management...

Managing nonconformities is a key aspect of maintaining quality in any organization. Non-conformity refers to ...

Maintaining stringent quality standards is a regulatory requirement and a fundamental necessity for ensuring m...