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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)

InstantGMP MD

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Page 1: InstantGMP MD

InstantGMP MD/PROElectronic Device History File Software for

Manufacturing Medical Devicesin compliance with 21 CFR Part 820

(Quality System Regulation) and Part 11 (Electronic Documentation)

Page 2: InstantGMP MD

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

Page 3: InstantGMP MD

InstantGMP Material Screen

InstantGMP ensures materials are in compliance with SOPs

Page 4: InstantGMP MD

Specifications and Version Control

Page 5: InstantGMP MD

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 #

Page 6: InstantGMP MD

InstantGMP Inventory Use Screen

Page 7: InstantGMP MD

InstantGMP Project Screens

Page 8: InstantGMP MD

InstantGMP Design History File Management

Page 9: InstantGMP MD

InstantGMP Design Master Record Tabs

Page 10: InstantGMP MD

InstantGMP Device Master Record Manufacturing Instructions

Page 11: InstantGMP MD

InstantGMP Device History Record Instructions Screen

Page 12: InstantGMP MD

Tracking of Inventory Distribution

Page 13: InstantGMP MD

InstantGMP Reports

Page 14: InstantGMP MD

Page 15: InstantGMP MD

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