Description: As industries in the Life Sciences undergo digital transformation, moving away from traditional Computer System ...

In this session, Compliance Group (CG) will showcase a Siemens ISV low-code Mendix mobile app enabling Manufacturing and Quality leadership to answer questions they have struggled with for years – ...

In today’s fast-evolving life sciences industry, leveraging Veeva’s cloud-based solutions is critical for maintaining a competitive edge. To drive long-term efficiency, the Veeva Services team ...

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 ...

ISO 13485:2016 is an international standard for medical device manufacturers and providers of quality management systems. ISO 13485:2016 is not a law or regulation and is voluntary, while FDA 21 CFR ...

The US Food and Drug Administration (FDA) is responsible for protecting public health by ensuring medical devices’ safety, efficacy, and quality. The agency has developed a rigorous medical device ...

The different processes involving multiple roles like supplier, production, manufacturer, and pieces of equipment for designing or marketing a product will inevitably invite some non-conformance ...

The significance of FDA Computer Software Assurance (CSA) cannot be overstated when it comes to laboratory systems in today's technological era. Embracing the CSA methodology is crucial as it promotes ...

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 ...

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 ...