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Revolutionizing Robotics: A Case Study on Polarion Risk Management Implementation by Compliance Group, Inc., for a Leading Global Innovator in Medical Technology ...

Explore how digital transformation is revolutionizing the life sciences industry. Learn how Compliance Group Inc ensures innovation while maintaining regulatory compliance.

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

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 ...

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

In the life sciences industries, documentation plays a crucial role in proving the product's effectiveness and safety. Document Change Control (DCC) denotes the documentation process.

MDIC’s Case for Quality took on the Make CAPA Cool project, the intent was to remove barriers to RCA and problem-solving. Engineers voiced frustration that they were spending most of their time in ...