InstantGMP™ MD Electronic Device History File Software for Manufacturing Medical Devices.

Slides:

Advertisements

Similar presentations

PRINCIPLES OF A CALIBRATION MANAGEMENT SYSTEM

Advertisements

21 CFR Part 11 course syllabus / Ilan Shaya 21CFR Pat 11 | Objective | Audience |Course Outline | Details 15-16/7/2013.

Radiopharmaceutical Production

Regulatory Auditing. Audit Areas Management Responsibility Auditing (internal and external) Design Control Document Control Purchasing Control Identification.

EDRN’s Validation Study Information Management System Developed for EDRN by the DMCC Cancer Biomarkers Group Division of Cancer Prevention Jet Propulsion.

Audit of IT Systems SARQA / DKG Scandinavian Conference, October 2002, Copenhagen Sue Gregory.

GMP Document and Record Retention

Statistical Process Control for the Medical Industry.

Regulatory Compliant Performance Improvement for Pharmaceutical Plants AIChE New Jersey Section 01/13/2004 Murugan Govindasamy Pfizer Inc.

Cheryl McCarthy Manager, Quality Assurance MBC Session October 3, 2008 GCP Compliance in our Vendors.

Biomedical Auditing. The Biomedical Auditor works with medical devices, including in vitro diagnostics and biologics that are regulated as medical devices.

Selecting and Implementing an LMS for your Company Session Code #2411.

PrimeSUITE’s Practice Management and Electronic Health Record Software

QAD Quality Management Systems Roll Out November 17, 2014.

Ground Control™ Document Control and Training Manager

C c c Comprehensive Cardiovascular Device Simulation Data and Process Management INTRODUCTION CONTACTS Cardiovascular related simulations such as nonlinear.

Laboratory Information Management Systems (LIMS) Lindy A. Brigham Div of Plant Pathology and Microbiology Department of Plant Sciences PLS 595D Regulatory.

Biomedical Engineering Design and the Promotion of High Value Relationships with Clinical Medicine Robert Hitchcock.

Instructions and forms

Computer Systems & Software

21 CFR Part 11 A Food Industry Perspective FDA Public Meeting June 11, 2004 Sia Economides Center Director Center for Development of Research Policy and.

Regulatory Overview.

MethodGXP The Solution for the Confusion.

Evolving IT Framework Standards (Compliance and IT)

ENVIROTRAC: A Premier Chamber Monitoring and Data Acquisition System Envirotrac A Guided Tour.

System software operating system 1.

Prof. Moustafa M. Mohamed Vice dean Faculty of Allied Medical Science Pharos University in Alexandria Development and Regulation of Medical Products (MEDR-101)

PERSONNEL TRAINING IN BIOANALYSIS DR. SHIVPRAKASH MANAGING DIRECTOR SYNCHRON RESEARCH SERVICES PVT. LTD., INDIA.

Product Development Chapter 6. Definitions needed: Verification: The process of evaluating compliance to regulations, standards, or specifications.

InstantGMP: Electronic Batch Records System for GMP Manufacturing InstantGMP™ Inventory Control Module for GMP Manufacturing.

PwC 21 CFR Part 11 – A Risk Management Perspective Patrick D. Roche 07 March 2003, Washington D.C.

The IT Quality Assurance FDA Validation Specialists Phone: 877-MGD-TEST ( ) n n n n Web Site:

Values That Stand The Test of Time A CASE STUDY: The modification of a legacy process control system [The case for data integrity without “Part 11" compliance]

7-1 Computerized Accounting Systems Electronic Presentation by Douglas Cloud Pepperdine University Chapter F7.

Computer Components: Software Computer Technology.

Good Manufacturing Practices and InstantGMP Overview.

MVS Express Electronic Filing IFTA & IRP Instructions - Initial Login Before attempting to login, please ensure that all popup.

GOOD DOCUMENTATION PRACTICES (GDP)

InstantGMP MD/PRO Electronic Device History File Software for Manufacturing Medical Devices in compliance with 21 CFR Part 820 (Quality System Regulation)

EXCEL SPREADSHEET VALIDATION FOR FDA 21 CFR PART 11.

SEMINAR ON, PRESENTED BY, POONAM Y AGHARA M – PHARM DEPT. OF PHARMACEUTICS AND PHARMACEUTICAL TECHNOLOGY L. M. COLLEGE OF PHARMACY AHMEDABAD.

Good Manufacturing Practices and InstantGMP Orientation.

Workshop on Accreditation of Bodies Certifying Medical Devices Kiev, November 2014.

ValGenesis Closed Loop Change Management ValGenesis, Inc Christy Street, Fremont, CA Ph:

Integrated diabetes healthcare Frank Westermann CEO mySugr GmbH

Good Manufacturing Practices and InstantGMP™ Software Orientation Slides.

All Hands Electronic Information Integrity Call White Paper An Introduction to the Current State of EMR – et.al. R. L. Chamberlain, Ph.D.

Ensuring Quality Mobile Apps with Testing and Crash Reporting Seth Valdetero.

Chapter 4. CONCEPT OF THE OPERATING SYSTEM MANAGING ESSENTIAL FILE OPERATIONS.

AET 545 Week 3 Learning Team E-Learning Platform Evaluation Matrix and Rationale Investigate, individually, three e-learning platforms to share with the.

Международные требования к использованию электронных систем в клинических исследованиях Timur Galimov, CTO.

The staff at InstantGMP prepared the GMP for Dietary Supplements Compliance Series of presentations to focus on good manufacturing practices and GMP compliance.

Medical Device Survey 2015 Data from 22 NBs

Raechel Huebner Ruthanne Sherer

EffiChem Presentation

T R A I N I N G Microphone Setup

Simplified Messaging System

IBM Software Group | Tivoli Brand Software

Medical Device Survey 2014 Data from 25 NBs

EDRN’s Validation Study Information Management System

Unit I Flash Cards Start.

مشـكلات معتبر سازي تأسيسات و تجهيزات در موسسه رازي

Medical Device Survey 2017 Data from all members - 24 NBs

FDA Regulated Special Interest Group

Medical Device Survey 2016 Data from 21 NBs

Medical Device Survey 2018 Data from all 23 members (end 2018)

ISO 13485:2003 Requirements that overlap with ISO 9001

Radiopharmaceutical Production

Validation and 21 CFR Part 11 Compliance

Computer System.

Presentation transcript:

InstantGMP™ MD Electronic 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 Pre-validated to comply with Part 11, GAMP 5 and the FDA requirements for computer validation

Regulatory Requirements and InstantGMP

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