Documents and records prove that the company procedures align with compliance and regulation practices while designing, developing, and managing the life sciences products. It is a systematic process ...

Change management is when an organization creates a step-by-step protocol to manage and implement modifications to products and processes. A change management plan is a protocol that implements and ...

So, Quality Management System has produced a step-by-step process to help companies handle the CAPA process to get satisfactory results in adherence to ISO (International Standards Organization) FDA ...

Packaging and sterilization validations are a critical step in the development and manufacturing of medical devices, as they ensure patient safety, regulatory compliance, product quality, and the ...

When a company is issued an FDA 482 Notice of Inspection and FDA 483 Warning Letter, it must prepare and be ready for the long adventure it will have to take with the FDA. Receiving an FDA 482 means ...

Modern technology is always crucial to the advancement of the healthcare sector and the quality of healthcare provided to patients. Technology enables medicine to change, adapt, and advance, from the ...

In the life sciences industries, documentation plays a crucial role in proving the product’s effectiveness and safety. Furthermore, it discusses the processes and practice’s dependability, ...

Bird-brained. Has anyone ever been called that? It’s definitely not a compliment. However, a bird’s eye view is considered good, like being in the crow’s nest or traveling straight as the crow flies.

Organizations must develop a written method to approve papers for sufficiency prior to issuance. Documents should be reviewed, updated as needed, and re-approved. Determine the changes and the current ...

Quality Records and Documents – Non-Conformances (NC), Corrective Actions and Preventive Actions (CAPA), Change Requests (CR), Bill of material (BOM), Complaints, SOPs, Work Instructions, ...

From hearing aids to ultra-tech pacemakers, the medical device industry is a ground-breaking and innovative field full of opportunities. Though the manufacturers are passionate about delivering ...

Bygones are those days when quality management systems (QMS) were largely confined to expensive, on-site platforms designed specifically for larger corporations. Nowadays, a plethora of adaptable ...