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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 ...

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 ...

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 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 ...

For health and life sciences organizations, compliance with regulatory requirements is non-negotiable. Historically, Computer Systems Validation (CSV) has been the focus of QA and compliance ...

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 ...

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

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 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 ...

Polarion is a web-based application lifecycle management (ALM) platform that allows teams to manage requirements, test cases, defects, and other artifacts collaboratively. Polarion also provides a ...