InstantGMP MD
•Download as PPTX, PDF•
2 likes•471 views
InstantGMP MD is the latest version of InstantGMP's good manufacturing practices software. MD brings manufacturers of medical devices into cGMP compliance by coming fully validated and compliant with Part 820.
More Related Content
Viewers also liked
Viewers also liked (19)
Similar to InstantGMP MD
Similar to InstantGMP MD (20)
More from InstantGMP™
More from InstantGMP™ (20)
Recently uploaded
Recently uploaded (20)
InstantGMP MD
- 1. InstantGMP MD/PRO Electronic Device History File Software for Manufacturing Medical Devices in compliance with 21 CFR Part 820 (Quality System Regulation) and Part 11 (Electronic Documentation)
- 2. InstantGMP QSR - Process Flow Identify materials and products Select and qualify suppliers Set tests and specifications Purchase materials and components Receive materials and components Prepare electronic Device Master Record Attach Design History File to DMR Produce using electronic Device History Record Ship out quality device Release finished device Design, Develop, Validate - Write Design History File
- 3. InstantGMP Material Screen InstantGMP ensures materials are in compliance with SOPs
- 4. Specifications and Version Control
- 5. System Generated Numbers Inventory Warehouse Receiving Purchase Order Raw Material Part # Requisition # Receipt # Specification Version # MDR # /Ver # DHR/Batch # Production Master Record Specifications Receipt # Requisition # Part #
- 6. InstantGMP Inventory Use Screen
- 8. InstantGMP Design History File Management
- 9. InstantGMP Design Master Record Tabs
- 10. InstantGMP Device Master Record Manufacturing Instructions
- 11. InstantGMP Device History Record Instructions Screen
- 12. Tracking of Inventory Distribution
Editor's Notes
- When a new material is entered into InstantGMP, you can identify what type of material it is, for example, a raw material, a component or a Finished Good. You can describe how the material appears and assign a unit of measure to it. You can associate it with a specific vendor and record a vendor order number. Overall, InstantGMP will ensure that each material that you enter is kept in compliance with FDA regulations and with the SOPs.
- With InstantGMP, you can keep track of each use of a material in real time. This will maintain a history of the material so you can always see where it went and how it was used.
- With InstantGMP, you can keep track of each use of a material in real time. This will maintain a history of the material so you can always see where it went and how it was used.
- With InstantGMP, you can keep track of each use of a material in real time. This will maintain a history of the material so you can always see where it went and how it was used.
- There are many sections of a MPR such as the Cover Page, the Bill of Materials, the Equipment List, In-Process Tests and the Manufacturing Instructions.
- The MPR manufacturing instructions give you complete control of each step of the manufacturing process.
- This is an example of the screen that operators will use to enter their results during batch production.
- InstantGMP allows for tracking inventory and maintaining a history of it distribution. Each time some material is used up, a record of use, the amount used and purpose is entered. This information is available on-line so it is easy to keep track of where the inventory is located and how it was used.
- The Production Lot Traceability Report will show which component lots were used in any specific batch..
- If any component lot is identified as having issues or was used in a finished product that was recalled, the Vendor Lot Traceabilty report that can identify all of the production batches where that component lot was used.