Ensure your AI systems in MedTech meet compliance standards. Join our webinar on AI governance strategy and regulatory best ...

Rapidly develop, manage and adopt user friendly apps across business processes in life sciences with Compliance Group's Mendix solutions ...

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.

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 ...

ISO 9001 enables an organization to adjust the documentation as applicable as long as the overall objectives are met.

Title 21 CFR Part 11 is the portion of Code of Federal Regulations that provides standards determined by the Food and Drug Administration (FDA) on electronic records and electronic signatures. With ...

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

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

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 ...

CAPA in eQMS Software (electronic quality management software) is a technological innovation developed to automate quality processes.