This webinar explores how the life sciences industry is navigating complex supply chain challenges driven by evolving regulations, rapid technological advancements, and shifting healthcare ...

The FDA’s Final CSA Guidance represents a significant step in modernizing validation across the industry. While it brings clarity, many questions remain about interpretation, practical application, ...

From CSA to digital transformation, our experts turn compliance into a competitive advantage. OCM bridges the gap between innovation and adoption—ensuring your workforce is ready when change occurs.

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 ...

As the English saying goes, “Potato, Potato” doesn’t translate well in the written form. Still, it’s saying the same vegetable but with a different pronunciation, meaning it doesn’t matter how you say ...

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 ...

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 ...

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 ...

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

As the pace of digital transformation and automation accelerates, the need for a robust and lean risk assessment methodology for software is becoming more and more critical in the life sciences ...

FDA (Food and Drug Administration) issued a draft guidance to offer recommendations on Computer Software Assurance (CSA) for automated data processing systems that are used as a part of medical device ...

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, ...