InstantGMP™ MDElectronic Device History File Software for Manufacturing

Medical Devices

InstantGMP™ MD – Medical Device Manufacturing Software• Cloud based Electronic Device History software• Software guides users through the work flows required for

manufacturing medical device products of all classes• Compliant with Part 820 and the production requirements of ISO

13485• Pre-validated to comply with Part 11, GAMP 5 and the FDA

requirements for computer validation

Regulatory Requirements and InstantGMP

ClinicalTrials

IDESubmission

510KSubmission

MarketApproval

CFR 21 Part 807ISO 13485

Design Prototype Specifications/Mfg Procedure

Design History File

ISO 13485

CustomerFeedback

DistributeProduct

Device History Record

DeviceMaster Record

PurchaseMaterials

CFR 21 Part 820 and InstantGMP Functionality

SetSpecifications

InstantGMP Medical Device Manufacturing Work Flows

Enter products to be manufactured

Enter materials needed for manufacturing

Establish material and product specifications

Requisition materials and components

Receive materials into inventory and approve for use

Prepare Device Master Record Add batch to inventory

Device Master Record Work Flow

Generate Device History Record

Device History Record Work Flow

Organize Products into Projects Capture production data

System Generated Numbers

Warehouse Receiving

Purchase Order

Material

Part #

Requisition #

Receipt #

Specification w/Version Control

DMR w/Version Control

Batch #Device History Record

Device Master Record

Specifications

InstantGMP Material Screen

InstantGMP ensures materials are in compliance with SOPs

Specifications and Version Control

InstantGMP Inventory Use Screen

InstantGMP Project Screens

InstantGMP Device Master Record Tabs

InstantGMP Device Master Record Manufacturing Instructions

Device History Record Instructions Screen

Tracking of Inventory Distribution

InstantGMP Reports