Think about that for a moment: Do you wait until every bit of information is validated and proven before you act? Or do you make the best judgment possible with the information you have so you can ...

Are you concerned that your project is not going as planned? Are people frustrated, resistant, or even a little angry? Guess what? It’s normal. Change is a process, and major transitions often bring ...

Change Management, as you may know, involves the process and methodology focused on the people side of change. In simple terms, it’s about helping people succeed through change, enabling your ...

Extending the Part 1 conversation, the second part will dive deeper into the evolving viewpoint on AI governance in MedTech. Learn how to align your strategies with current and upcoming regulatory ...

Join our webinar to explore AI solutions that streamline manufacturing, enhance productivity, and improve operational efficiency ...

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 ...

The development of new medical devices or any new project brings a new set of risks. A Risk Management Plan (RMP) must be developed at the start of the Risk Management Process for a new project or ...

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, ...

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

The vision and methodologies of Process Analytical Technologies (PAT) closely align with emerging trends such as Industry 4.0 and Internet of Things (IoT). Although these trends have gained ...

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 ...