Here is a comprehensive glossary of terms related to MedTech & Pharmaceuticals and associated domains.
|
S.No. |
Abbreviation | Term |
Definition |
| 1. | ALM | Application Lifecycle Management | The management of an application’s lifecycle from inception through retirement, covering requirements, design, development, testing, and maintenance. |
| 2. | ADLM | Application Development Lifecycle Management | A methodology for managing the entire lifecycle of an application. |
| 3. | SaMD | Software as a Medical Device | Software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device. |
| 4. | RTM | Requirements Traceability Matrix | A document mapping requirements to test cases to ensure full coverage. |
| 5. | – | Requirements Traceability | Tracking requirements from origin to implementation to ensure product compliance and quality. |
| 6. | BRD | Business Requirements Document | A document that defines the business objectives, needs, and scope for a project. |
| 7. | FRD | Functional Requirements Document | A document detailing the functional specifications and features of a project or product. |
| 8. | NFRD | Non Functional Requirements Document | A document defining the non-functional aspects of a project, such as performance, usability, and security. |
| 9. | MBSE | Model-Based Systems Engineering | A methodology focusing on using models to design and analyze systems. |
| 10. | SysML | Systems Modeling Language | A graphical language for modeling complex systems in MBSE. |
| 11. | CI | Continuous Integration | A practice where code changes are automatically integrated, built, and tested. |
| 12. | BPM | Business Process Modeling | Representing processes in a visual format to analyze and improve workflows. |
| 13. | – | Validation | Ensuring that a system meets user needs and intended purposes. |
| 14. | – | Verification | Ensuring that a system meets specified requirements. |
| 15. | CSV | Computer System Validation | A documented process demonstrating that computerised systems used in medical device quality systems consistently perform as intended and meet predetermined specifications. |
| 16. | QA | Quality Assurance | Ensuring that processes and deliverables meet specified standards through systematic evaluation. |
| 17. | FMEA | Failure Mode and Effects Analysis | A methodology for identifying potential failure modes in a process or system and assessing their impact. |
| 18. | FMECA | Failure Mode, Effects, and Criticality Analysis | An extension of FMEA that includes criticality analysis to prioritize risks. |
| 19. | CAPA | Corrective and Preventive Action | A system for implementing preventive actions and corrective actions resulting from the investigation of complaints, product rejections, and other nonconformities. |
| 20. | ALCOA | Attributable, Legible, Contemporaneous, Original, Accurate | Core principles used to ensure data integrity and quality in regulatory environments. |
| 21. | cGMP | Current Good Manufacturing Practice | FDA requirements governing the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, and storage of medical devices and pharmaceuticals. |
| 22. | GAMP | Good Automated Manufacturing Practice | Guidelines for companies involved in the development and implementation of automated manufacturing systems for the pharmaceutical and related industries. |
| 23. | DHF | Design History File | A repository for all records that demonstrate how a medical device was developed in accordance with an approved design plan. |
| 24. | DMR | Device Master Record | A compilation of all the instructions, drawings, documented specifications, labeling, and packaging requirements that must be used to produce a medical device. |
| 25. | DHR | Device History Record | The combination of records containing the entire production history of a finished medical device. |
| 26. | – | FDA 21 CFR Part 11 | The Code of Federal Regulations regarding the use of electronic records and electronic signatures to replace paper-based documentation in a compliant way. |
| 27. | – | IEC 62304 | The international standard for medical device software lifecycle processes, defining requirements for the development and maintenance of medical device software. |
| 28. | – | ISO 13485 | The internationally recognized Quality Management System (QMS) standard specific to medical devices, ensuring regulatory compliance and product quality. |
| 29. | – | ISO 14971 | The current international standard for medical device risk management, providing a framework for systematically identifying, controlling, and monitoring risks throughout the entire device lifecycle. |
| 30. | – | Vendor Management | Overseeing and coordinating interactions with vendors to ensure value and efficiency. |
