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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 ...

CAPA PROCESS STEPS The CAPA process comprises seven steps as highlighted below. Step-by-step risk-based CAPA process Identification Evaluation Investigation & Analysis Action Plan Review and ...

A risk management plan (RMP) must be developed at the start of the risk management process for a new project or device development.

Records and Documents in QMS linking is a feature in QMS to help identify the pairs of relevant information representing the same entity.

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 ...

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 ...

Article Context: Computer System Validation Computer System Assurance CSA (vs) CSV Advantages For health and life sciences organizations, compliance with regulatory requirements is non-negotiable.

Implementing CSA for lab systems offers several benefits, including faster deployment and a higher ROI by streamlining the validation process.

Development of AI/ML (Artificial Intelligence/Machine Learning) technologies has raised concerns regarding regulatory compliance. CSA/CSV (Computer Software Assurance / Computer System Validation) ...