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Article Context: Quality Records and Documents ISO 9001 Quality Management Principles What is record linking, document linking, and record-document linking? Importance of Record Document Linking ...

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 ...

Conversational AI AssistantArticle Context: ISO 9001 QMS ISO 9001 Documentation Requirements ISO 9001 ISO 9001:2015 requires a list of obligatory documents. The QMS ‘s scope will include the following ...

Article Context: Change Management Change Management Process Change Request Review How to Manage the Change Management Process? What is Change Management? Change management is when an organization ...

Article Context: Importance of USFDA Process Process for Device Validation Validation and Verification of Medical Devices Significance of Process Validation for the manufacturers of Medical Devices ...

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 ...

Article Context: FDA 21 CFR Part 820 (vs) ISO 13485 (2016) Similarities between FDA 21 CFR Part 820 and ISO 13485 (2016) ISO 13485:2016 is an international standard for medical device manufacturers ...

Article Context: Packaging Sterilization Testing Process Optimization Packaging and sterilization validations are a critical step in the development and manufacturing of medical devices, as they ...

Considerations for a good CSA program: Strong Quality Management System can contribute for an easy implementation of a good CSA program: A strong Supplier Assessment Program. Use a risk-based approach ...

Article Context: Document Design Control Why DCC? FDA 21 CFR Part 11 FDA 21 CFR Part 820.40 ISO-13485:2016 How to implement a Document Change Control-DCC? In the life sciences industries, ...