Tiêu đề Medstrategist Scope Document Phase I - II consollidated.docx.pdf ✅

F22 Labs Product Scope Documentation Medstrategist Introduction The aim of this document is to outline the features, characteristics, and functionalities of a Quality Management System (QMS). Product Name: "MedStrategist" Product Vision To design a robust, data-driven, and scalable QMS that enhances workflow efficiency, reduces errors, and fosters a culture of continuous improvement in the organization. And also to implement some of the basic features which are available in products like Odoo , thereby implementing an ERP system supporting our primary QMS application. This will encourage the users to use our application as an end to end solution for their organization. This product is intended to target the following modules Non Optional Modules Optional Modules ● Competency and training ● Audit Management ● CAPA ● Analysis of Data ● Document Management ● Management Review Management ● Complaint Management ● Infrastructure Management ● Control of Monitoring and Measuring Equipment. ● Design and Development ● Design Change ● Risk management ● Supplier/Outsourcing Management ● Process Validation ● Marketing and Sales ● Manufacturing integration ● Post Market Surveillance ● Post Market Clinical Followup ● Regulatory Submissions 1. I-MDR 2. EU-MDR 3. US-FDA (for future scope) 4. MDSAP (non - exhaustive list) Both optional and non-optional modules will be applicable for the below mentioned Version 1.0 F22 Labs Global Private Limited Page 1
F22 Labs Product Scope Documentation Product Categories: Medical devices In Vitro Diagnostics (IVD) 1. Non active medical device 2. Active medical device 2.1 SaMD 1. Non Active medical device 2. Active medical device Product Objective ● To automate and streamline Quality Management Processes. ● To ensure compliance with industry Standards, such as - ISO 13485:2016 - EN ISO 13485:2016 + A11:2021 - Indian-MDR 2017 - Fifth Schedule - 21 CFR 820 Quality System Regulation ● To ensure compliance with various Regulatory Requirements like - Indian regulation - EU - USA - MDSAP ● To capture inputs from clients and fulfill the documents required for a given process. ● To effectively address various issues with the products, identify the root cause and come up with a solution. ● To facilitate both internal and external audits and find out areas for improvement. ● To capture employee skills and to plan and organize training if required. ● Provide product traceability functionality ● Track and document every event and process that occurs during the product life cycle ● Monitor industry regulation and set up reminders and/or triggers for potential violations ● Capture customer complaints to assess and manage risk ● Facilitate product testing and inspections ● Provide support and workflows for corrective actions to tested products Product Types ● A Web-based application will be built with multiple features. Version 1.0 F22 Labs Global Private Limited Page 2
F22 Labs Product Scope Documentation ● A Mobile application will be built with scanning functionality. 1. Global Data 1.1 Departments/ Functions Predefined list of functions which can be expanded further at organization level ● Purchase ● Quality Management ● Manufacturing ● Sales ● Design ● Marketing ● Regulatory ● Customer Support ● Infrastructure ● Human Resource ● Delivery 1.2 Department Roles This information will be added directly to the backend. ● List of Roles and Departments/Functions : ○ Design and Development, ○ Manufacturing, ○ Distribution, ○ Customer Service, ○ Sterilization, ○ Supplier of Components, ○ Calibration ● A matrix which gives the relationship between roles-department. 1.3 User Roles & Permissions The following are the list of User Roles. Quality Management System Head Management Representative Version 1.0 F22 Labs Global Private Limited Page 3
F22 Labs Product Scope Documentation Design Head Design eng - Manufacturing design - XYZ design Verification eng MFG Head - Supervisor - Assembly Eng Quality Assurance & Control Head - QC eng - QA eng Marketing Head Sales Head Infrastructure Head HR Head Customer Support Head Purchase Head Quality Management System Head Regulatory Head Person responsible for regulatory compliance Depending on the roles, the user can have the following Permissions ● Process owner- To create ● Approver The Control of Documents , gives information on who has access to what document. Ref: https://docs.google.com/document/d/1N0qo6yRph7-bktzCf0zvI1Sf94cSgJP4/edit Version 1.0 F22 Labs Global Private Limited Page 4