ISO 13485, ISO 14971
ISO 13485 Software, ISO 14971 Software, FDA: CEBOS’ Quality Management Software Compliance Made Easy
Today’s life sciences organizations are under intense scrutiny given the public’s desire for safe products. This extends to all parts of the organization including the design, manufacture and distribution of an organization’s products. Consequently, managing the quality management system (QMS) to ISO 13485, ISO 14971, xGmP and other FDA requirements is certainly no easy task! Compounding this is that life sciences organizations have an emphasis on regulatory (e.g., QSR Title 21 Part 820, 21 CFR Part 11, etc.) and risk management (ISO 14971) requirements as well. Unfortunately, many of the traditional systems being used to manage the QMS for these requirements are not sufficient due to the following inefficiencies or shortcomings:
- Redundancy and extra steps associated with maintaining islands of data (e.g.; Email, Word, Excel, and Access)
- Lack of integration and links to related data across the QMS (e.g., document change requests to training personnel, audit findings to CAPA, etc.)
- Manually generated, inaccurate, out of date reports that attempt to provide enterprise visibility
There is help immediately available! CEBOS’ MQ1 quality management software, Life Sciences Solution, is a completely automated, integrated, quality management system geared specifically to the requirements of ISO 13485, ISO 14971, FDA requirements and more. Functionality includes electronic signatures, audit trail and validation scripts. The software significantly reduces the time organizations spend to complete and maintain compliancy while ensuring that staff know exactly what and when to complete required tasks.
To view CEBOS’ practical guide on software validation please click on the following link “The Secret Code of Software Validation – In 5 Easy Steps“.
ISO 13485 / ISO 14971 / FDA: Quality Management Requirements Needs Matrix
| 13485 / 14971 Attribute | Compliance Requirements Covered with MQ1 Software |
| Product Planning and Realization | Customer Requirements and Related Processes, Customer approved sources, Product Realization, Multi-disciplinary approach, Change Control, Engineering Specifications, Process Flow, FMEA, Acceptance Criteria, Special Characteristics, Control Plans, Error-Proofing, Personnel Safety, Work Instructions, Prototype and Product Approval Process (PPAP), and Preservation of Product |
| Risk Management | Risk management plan, risk analysis and risk analysis process, identification of hazards, estimation of risks, risk control, risk reduction, risk reporting, FMEA, control plans, and error-proofing |
| Audits | Internal Audits (Process, Product and System audits), Audit Planning, Internal Auditor Qualification, Management Review, Cleanliness of Premises, Work Environment, Storage and Inventory |
| Customer Management | Customer Focus, Customer Feedback and Satisfaction, Customer Communication, Customer Property, and Manufacturing Feasibility |
| Data Collection | Monitoring & Measuring of Products/Processes; Verification of Job-set-ups, Layout Inspection and Functional Testing, Identification and Traceability |
| Document Control and Management | Quality Policy, Quality Manual, Control of Documents/Drawings, Control of Records, Work Instructions, Process approval, Engineering Specifications, and Laboratory requirements |
| Employee Skill Management and Competency | Responsibility and Authority, Competence Awareness, Employee Motivation and Empowerment, Training Needs Analysis, Maintenance of Training Records, Knowledge of Statistical Processes, Contingency and Succession Planning |
| Gage | Control of Monitoring and Measurement Devices, Measurement System Analysis, Calibration Verification Records |
| Equipment Maintenance | Preventive and Predictive Maintenance, Infrastructure Maintenance, Plant, Facility and Equipment Planning, and Management of Production Tooling |
| Problem Solving | Control of Non-conforming and Reworked product, Corrective Action, Preventive Action, Problem Solving, Customer Review (Deviations), Identification and traceability and Corrective Action Impact, Pre-configured with MedWatch form 3500 |
| Supplier Performance Management | Supplier Evaluations and Performance Monitoring, Supplier Quality Management System Development, Verification of Purchased Product (Incoming Product Quality), Regulatory Conformity, Control of Purchasing Process, Customer Property |
| Program/Project Management | Product and Quality System Planning, Design and Development Planning, Design Verification and Validation, Continual Improvement, Confidentiality Protection, Multi-disciplinary Approach, Management Commitment, Management Monitoring and Review, Internal Communication, Action Plans |
| Key Performance Measurement and Reporting and effective process monitoring | Quality Objectives, Analysis of Data, Process Efficiency and Effectiveness, Performance Trends Measurement, Management Review (utilizing graphical scorecards), Continual Improvement, Employee Motivation and Empowerment |