FDA and Industry Collaboration on Computer Software Assurance (CSA)

Size: px
Start display at page:

Download "FDA and Industry Collaboration on Computer Software Assurance (CSA)"

Transcription

1 FDA and Industry Collaboration on Computer Software Assurance (CSA) Q & A Session with Francisco Vicenty on the Draft FDA CSV Guidance Francisco (Cisco) Vicenty Program Manager Case for Quality Office of Compliance Center for Devices and Radiological Health (CDRH) U.S. Food and Drug Administration Khaled Moussally Head of Quality Management Systems Compliance Group 1

2 Q&A Session s Agenda Overview / Background Quick recap on FDA CSV Team s journey & Draft Guidance for CSA Recent updates to the guidance Questions and Open Discussion from the following Companies: MEDPACE CONVATEC VERICEL ICU MEDICAL REGENERXBIO JUUL LABS WL GORE & ASSOCIATES Q&A Session s Objectives Create awareness to accelerate innovation Inspire action so you can begin to realize value

3 Overview and Background Although FDA Title 21 CFR Part 11 was introduced in 1997 to regulate the use of computerized systems, many Life Science companies still struggle with the complexities and cost to comply, and remain using paper-based, manual tools for documentation and quality management. The automation of digital technologies has been particularly slower in the medical device Industry. According to FDA s Francisco (Cisco) Vicenty, Program Manager, Case for Quality at FDA s CDRH, the MedTech industry s high focus on meeting regulatory requirements versus adopting best quality practices has the potential to increase risk to patients. This compliance-centric approach has resulted in quality issues and has hampered innovation in manufacturing and product development practices. In an effort to harmonize with international standards, the FDA (CDRH) announced in their FY 2019 Proposed Guidance Development list to release a new draft guidance, Computer Software Assurance for Manufacturing, Operations, and Quality System Software, that aligns with the current quality systems regulation ISO

4 Journey of FDA CSV Team FDA Case for Quality begins 2015 Q2 Siemens Fresenius Executive Exchange w/ FDA: CSV Barrier identified 2016 Q1 Industry team formed / recommendation development begins Begin promoting recommendations: Zoll Lifevest + Medtronic value examples 2017 FDA A List status for CSA Draft Guidance More examples developed More firms applying recommendations (Vericel, ICU Medical, Gilead, etc) More industry adoption CSA Draft Guidance release targeted for 2019

5 The Industry CSV Team Company Name Company Name Baxter Healthcare Tina Koepke Johnson and Johnson Dana Guarnaccia Boston Scientific Damien McPhillips Johnson and Johnson Ron Schardong Boston Scientific Ray Murphy Medtronic Frankie Bill Compliance Group Khaled Moussally Medtronic Michael Branch Edwards Lifesciences Penny Sangkhavichith Medtronic April Francis Edwards Lifesciences Andy Lee NeuroVision Imaging Pepe Davis FDA Cisco Vicenty Ortho-Clinical Diagnostics Des Chesterfield FDA John Murray Siemens PLM Jason Spiegler Fresenius Medical Care Bill D'Innocenzo Siemens PLM Greg Robino Fresenius Medical Care Curt Curtis Siemens PLM Thorsten Ruehl Fresenius Medical Care Marc Koetter Zoll Lifevest Frank Meledandri Sr. Contributions also provided by past team members: Stacey Allen, Jason Aurich, Sean Benedik, Laura Clayton, Bill Hargrave, Joe Hens, Scott Moeller & Mark Willis 8

6 Questions 1. If we pilot the new guidance, how should we handle the fact that we would not be following our current SOPs? Should an interim set of SOPs be developed? 2. In the pilots that are happening now, how are Sponsor Auditors reacting to this new way of approaching validation? 3. Can you clarify how the use of test automation fits into this new guidance? What kind of evidence would we be expected to provide when performing validation using test automation? 4. How much documentation is the FDA truly expecting we produce as compared to what we produce today? 5. How long do you think it will take for the paradigm to shift in the minds of Auditors? Today Auditors are expecting the current level of documentation we produce today. 6. What kind of communication/training/education is the FDA planning on doing to promote this new guidance? 7. Is the new guidance changing with respect to COTS systems, in terms of a company s current responsibility to verify fitness for intended use?

7 For Additional Questions Contact: Khaled Moussally Cisco Vicenty Jason Spiegler 33

Data Management and Good Clinical Practice Patrick Murphy, Research Informatics, Family Health International

Data Management and Good Clinical Practice Patrick Murphy, Research Informatics, Family Health International Data Management and Good Clinical Practice Patrick Murphy,, Family Health International 1 What is GCP? Good Clinical Practice is an international ethical and scientific quality standard for designing,

More information

Contains Nonbinding Recommendations

Contains Nonbinding Recommendations Guidance for Industry and FDA Staff Laser Products Conformance with IEC 60825-1 and IEC 60601-2-22; Guidance for Industry and FDA Staff (Laser Notice No. 50) Document issued on June 24, 2007 This document

More information

What is Process Validation?

What is Process Validation? What is Process Validation? Process Validation is defined as the collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process

More information

Document Control SOP. Document No: SOP_0103 Prepared by: David Brown. Version: 10

Document Control SOP. Document No: SOP_0103 Prepared by: David Brown. Version: 10 1.0 Commercial in Confidence 16-Aug-2006 1 of 6 Document Control SOP Document No: SOP_0103 Prepared by: David Brown Date: 16-Aug-2006 Version: 10 1.0 Commercial in Confidence 16-Aug-2006 2 of 6 Document

More information

Computerized System Audits In A GCP Pharmaceutical Laboratory Environment

Computerized System Audits In A GCP Pharmaceutical Laboratory Environment IVTGXP_july06.qxd 6/28/06 1:09 PM Page 36 Computerized System Audits In A GCP Pharmaceutical Laboratory Environment By Maintaining data integrity for both clinical laboratory processes and patient data

More information

Guidance for Industry

Guidance for Industry Guidance for Industry Electronic Source Data in Clinical Investigations DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft

More information

2 Day Seminar Assuring Data Integrity in the Life Science industry

2 Day Seminar Assuring Data Integrity in the Life Science industry 2 Day Seminar Assuring Data Integrity in the Life Science industry Location 1: Boston Sep 08 09 Hilton Garden Inn Boston Logan Airport 100 Boardman Street, Boston, MA 02128 Hotel: 617-567- 6789 Location

More information

ooo- I542 (314 Brlngrng tnnovation to patient care worldwide April 23,2003

ooo- I542 (314 Brlngrng tnnovation to patient care worldwide April 23,2003 Dockets Manalgement Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852. RE: Docked+ Nos. 03D-0060,99D-1458,OOD-1538,OOD-1543,OOD-1542, and 000-l 539; Draft Guidance

More information

A Natural Products Association Presents. SQF Certification. Josh Grauso Technical Sales Director UL Registrar

A Natural Products Association Presents. SQF Certification. Josh Grauso Technical Sales Director UL Registrar A Natural Products Association Presents SQF Certification June 25, 2015 1:00-2:00pm Josh Grauso Technical Sales Director UL Registrar GoToWebinar Housekeeping: Attendee Participation Your Participation

More information

Use of Electronic Health Record Data in Clinical Investigations

Use of Electronic Health Record Data in Clinical Investigations Use of Electronic Health Record Data in Clinical Investigations Guidance for Industry DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding

More information

Total Product Lifecycle Management: Lowering Costs while Increasing Quality

Total Product Lifecycle Management: Lowering Costs while Increasing Quality Axendia Cambashi Inc. 668 Stony Hill Road, Suite # 316 PO Box 463 Yardley, PA 19067 Cummaquid, MA 02637 United States of America United States of America Tel: +1 (215) 262-8037 Tel: +1 (508) 362-3480 www.axendia.com

More information

IDC US UPCOMING EVENT CALENDAR

IDC US UPCOMING EVENT CALENDAR IDC US UPCOMING EVENT CALENDAR Software as a Service (SaaS) Summit Contact: Patty Caron, Program Director, pcaron@idc.com Lead Analysts: Michael Fauscette and Robert P. Mahowald September 17, 2008 San

More information

Guidance for Industry Part 11, Electronic Records; Electronic Signatures Scope and Application

Guidance for Industry Part 11, Electronic Records; Electronic Signatures Scope and Application Guidance for Industry Part 11, Electronic Records; Electronic Signatures Scope and Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research

More information

MDIC Case for Quality Forum Quality System Maturity Model Update

MDIC Case for Quality Forum Quality System Maturity Model Update Case for Quality Forum Quality System Maturity Model Update George Serafin Deloitte & Touche LLP 1 Quality System Maturity Model Project Team Team Members Company Pat Baird Baxter Jodie Bastian Stryker

More information

Software Verification and Validation

Software Verification and Validation Software Verification and Validation Georgia L. Harris Carol Hockert NIST Office of Weights and Measures 1 Learning Objectives After this session, using resources and references provided, you will be able

More information

GLP vs GMP vs GCP Dominique Pifat, Ph.D., MBA The Biologics Consulting Group dpifat@bcg-usa.com

GLP vs GMP vs GCP Dominique Pifat, Ph.D., MBA The Biologics Consulting Group dpifat@bcg-usa.com GLP vs GMP vs GCP Dominique Pifat, Ph.D., MBA The Biologics Consulting Group dpifat@bcg-usa.com Common Misconception Good Laboratory Practices 1) A quality system concerned with the organizational process

More information

CONDUCTING GLOBAL CLINICAL RESEARCH TRIALS:

CONDUCTING GLOBAL CLINICAL RESEARCH TRIALS: CONDUCTING GLOBAL CLINICAL RESEARCH TRIALS: COMPARING AND CONTRASTING FDA MEDICAL DEVICE REGULATIONS FOR CLINICAL INVESTIGATORS WITH ISO 14155:2011 Introduction Today s clinical research landscape for

More information

January 12, 2016. Dear Amy Yang:

January 12, 2016. Dear Amy Yang: DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 January 12, 2016 Amy

More information

MDIC Modeling and Simulation Summit

MDIC Modeling and Simulation Summit 1 Our Members Abbott Vascular, Abiomed, AdvaMed, ANSYS, AptivSolutions, B. Braun Medical, BD Becton, Dickinson & Co., Biomet, Inc., Boston Scientific, Cardiovascul`ar Research Foundation Skirball Center,

More information

FDA Software Validation-Answers to the Top Five Software Validation Questions

FDA Software Validation-Answers to the Top Five Software Validation Questions Whitepaper FDA Software Validation-Answers to the Top Five Software Validation Questions Author: Penny Goss, Penny Goss Technical Solutions The FDA (Food and Drug Administration) and IEC (International

More information

Training Course Computerized System Validation in the Pharmaceutical Industry Istanbul, 16-17 January 2003. Change Control

Training Course Computerized System Validation in the Pharmaceutical Industry Istanbul, 16-17 January 2003. Change Control Training Course Computerized System Validation in the Pharmaceutical Industry Istanbul, 16-17 January 2003 Change Control Wolfgang Schumacher Roche Pharmaceuticals, Basel Agenda Change Control Definitions

More information

The Gap Analysis Checklist

The Gap Analysis Checklist The Gap Analysis Checklist This table outlines the changes to align your organization with the 21CFR820 requirements. The applicable parts of the regulation that result in additions for the QSR are highlighted

More information

Interactive Session: Improving Phase Gate with Objective Target Appraisal

Interactive Session: Improving Phase Gate with Objective Target Appraisal Interactive Session: Improving Phase Gate with Objective Target Appraisal Ron Lasser Professor Electrical and Computer Engineering Marc Halpern Research Director Gartner, Inc. Portfolio Management Conference

More information

ORACLE CONSULTING GROUP

ORACLE CONSULTING GROUP ORACLE CONSULTING GROUP An Official United States Agent Firm for Foreign Establishments CONSULTING MEMORANDUM: DEALING WITH A MEDICAL DEVICE IN THE U.S. 5398 Golder Ranch Rd., Ste. 1 Tucson, Arizona 85739

More information

ORACLE AGILE PLM FOR THE MEDICAL DEVICE INDUSTRY

ORACLE AGILE PLM FOR THE MEDICAL DEVICE INDUSTRY ORACLE AGILE PLM FOR THE MEDICAL DEVICE INDUSTRY Enterprise PLM is a strategic approach to managing the lifecycle of a product throughout its full value chain: from initial requirements gathering through

More information

General Principles of Software Validation; Final Guidance for Industry and FDA Staff

General Principles of Software Validation; Final Guidance for Industry and FDA Staff General Principles of Software Validation; Final Guidance for Industry and FDA Staff Document issued on: January 11, 2002 This document supersedes the draft document, "General Principles of Software Validation,

More information

Guidance for Industry. 21 CFR Part 11; Electronic. Records; Electronic Signatures. Time Stamps

Guidance for Industry. 21 CFR Part 11; Electronic. Records; Electronic Signatures. Time Stamps Guidance for Industry 21 CFR Part 11; Electronic Records; Electronic Signatures Time Stamps Draft Guidance This guidance document is being distributed for comment purposes only. Comments and suggestions

More information

FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS FOOD AND DRUG ADMINISTRATION OFFICE OF OPERATIONS

FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS FOOD AND DRUG ADMINISTRATION OFFICE OF OPERATIONS SMG 1117.2112 FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS FOOD AND DRUG ADMINISTRATION OFFICE OF OPERATIONS OFFICE OF INFORMATION MANAGEMENT AND TECHNOLOGY OFFICE OF INFORMATION MANAGEMENT

More information

ISO 13485:201x What is in the new standard?

ISO 13485:201x What is in the new standard? ISO 13485:201x What is in the new standard? Eric Finegan, Quality Mgr, BTE Technologies, Inc. 2015-09-10 1 Presentation Slides This slide deck is the presentation performed on 2015-09-10. A more detailed

More information

Regulatory Considerations for Medical Device Software. Medical Device Software

Regulatory Considerations for Medical Device Software. Medical Device Software Medtec Ireland 2015 Wireless Medical Devices Regulatory Considerations for Medical Device Software Kenneth L. Block, RAC October 7, 2015 Galway, Ireland Offices: Dallas, Texas (12 employees) Tokyo, Japan

More information

Guidance for Industry

Guidance for Industry Guidance for Industry Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products For questions on the content of the guidance,

More information

Breakout Sessions: FDA s Regulation of Mobile Health and Medical Applications

Breakout Sessions: FDA s Regulation of Mobile Health and Medical Applications Breakout Sessions: FDA s Regulation of Mobile Health and Medical Applications 2015 Annual Conference Washington, DC Bakul Patel, Associate Director for Digital Health, Office of Center Director, Center

More information

Guidance for Industry Computerized Systems Used in Clinical Investigations

Guidance for Industry Computerized Systems Used in Clinical Investigations Guidance for Industry Computerized Systems Used in Clinical Investigations U.S. Department of Health and Human Services Food and Drug Administration (FDA) Office of the Commissioner (OC) May 2007 Guidance

More information

U.S. Food and Drug Administration

U.S. Food and Drug Administration U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA s website for reference purposes only. It was current when produced, but is no longer maintained

More information

FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS FOOD AND DRUG ADMINISTRATION OFFICE OF OPERATIONS

FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS FOOD AND DRUG ADMINISTRATION OFFICE OF OPERATIONS SMG 1117.22a FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS FOOD AND DRUG ADMINISTRATION OFFICE OF OPERATIONS OFFICE OF INFORMATION MANAGEMENT AND TECHNOLOGY OFFICE OF INFORMATICS AND

More information

How To Validate Software

How To Validate Software General Principles of Software Validation; Final Guidance for Industry and FDA Staff Document issued on: January 11, 2002 This document supersedes the draft document, "General Principles of Software Validation,

More information

Therapeutic Area Standards (TAS) Initiative Project Plan

Therapeutic Area Standards (TAS) Initiative Project Plan Therapeutic Area Standards (TAS) Initiative Project Plan Version: 2.0 Document Date: June, 2014 REVISION HISTORY Version Number Revision Date Description of Change 1.0 September, 2013 Initial Document

More information

Design Controls: Are They Worth the Effort?

Design Controls: Are They Worth the Effort? Design Controls: Are They Worth the Effort? Compliance-Alliance conducted a survey to measure the effects of FDA s design control regulation on the industry. Most respondents believe the controls have

More information

Session 8: Bring Your Own Device (BYOD) - Application in Clinical Trials

Session 8: Bring Your Own Device (BYOD) - Application in Clinical Trials Session 8: Bring Your Own Device (BYOD) - Application in Clinical Trials FIFTH ANNUAL PATIENT-REPORTED OUTCOME (PRO) CONSORTIUM WORKSHOP April 29-30, 2014 Silver Spring, MD Co-sponsored by Disclaimer The

More information

The Concept of Quality in Clinical Research. Dorota Śwituła Senior Clinical Quality Assurance Advisor

The Concept of Quality in Clinical Research. Dorota Śwituła Senior Clinical Quality Assurance Advisor The Concept of Quality in Clinical Research Dorota Śwituła Senior Clinical Quality Assurance Advisor 1 Agenda What is quality? How we define quality in clinical research? The standard components of a Quality

More information

How To Exempt From Reporting And Recordkeeping Requirements For Tv And Computer Monitors With Cathode Ray Tubes

How To Exempt From Reporting And Recordkeeping Requirements For Tv And Computer Monitors With Cathode Ray Tubes Guidance for Industry and FDA Staff Exemption from Certain Reporting and Recordkeeping Requirements for Television Receivers and Computer Monitors with Cathode Ray Tubes Document issued on October 20,

More information

Appropriate Use of Agile in Medical Device Software Development

Appropriate Use of Agile in Medical Device Software Development Appropriate Use of Agile in Medical Device Software Development Presented May 18, 2011 Software Division & Biomedical Division Joint Session David Walker Member, AAMI Agile TIR Working Group Agenda Overview

More information

Medical Device Innovation Consortium Device Product Quality Metrics

Medical Device Innovation Consortium Device Product Quality Metrics Medical Device Innovation Consortium Device Product Quality Metrics September 8, 2015 1 Presentation Outline Topics to be Addressed Team Members Timeline and Process Pre-Production Metric Development Production

More information

Process Validation: Practical Aspects of the New FDA Guidance

Process Validation: Practical Aspects of the New FDA Guidance Process Validation: Practical Aspects of the New FDA Guidance ISPE Boston Chapter Meeting April 18, 2013 Rusty Morrison Commissioning Agents, Inc. Objectives / Summary What is Process Validation? Regulatory

More information

ICH Q10 - Pharmaceutical Quality System

ICH Q10 - Pharmaceutical Quality System WCC PDA Dinner Meeting Jan 2012 ICH Q10 - Pharmaceutical Quality System Neil Wilkinson NSF-DBA www.nsf-dba.com ICHQ10.1 WCC PDA Dinner Meeting Jan 2012 Your Presenter Partner at NSF-DBA USA Training, Consultancy,

More information

Best Practices in Identity and Access Management (I&AM) for Regulatory Compliance. RSA Security and Accenture February 26, 2004 9:00 AM

Best Practices in Identity and Access Management (I&AM) for Regulatory Compliance. RSA Security and Accenture February 26, 2004 9:00 AM Best Practices in Identity and Access Management (I&AM) for Regulatory Compliance RSA Security and Accenture February 26, 2004 9:00 AM Agenda Laura Robinson, Industry Analyst, RSA Security Definition of

More information

Safety Assurance Cases: What the medical device industry is doing

Safety Assurance Cases: What the medical device industry is doing Safety Assurance Cases: What the medical device industry is doing Sherman Eagles SoftwareCPR seagles@softwarecpr.com BECOMING AWARE 3 Early steps to awareness 2005 EWICS TC7 medical device group begins

More information

Standard Operating Procedure for the Data Update Process. June 5, 2014 Version 2.0

Standard Operating Procedure for the Data Update Process. June 5, 2014 Version 2.0 Standard Operating Procedure for the Update Process June 5, 2014 Version 2.0 Table of Contents I. INTRODUCTION...1 II. PURPOSE AND SCOPE...1 III. ROLES AND RESPONSIBILITIES...1 IV. PROCESS ENABLERS...2

More information

Validation Consultant

Validation Consultant Personal Data Name Title Validation Consultant Contact jsb-validierung Zwischen den Bächen 9 D 79618 Rheinfelden Tel: +49 7623 79 49 82 Mobile: +49 172 737 84 86 E-Mail: Internet: jsb-val@online.de http://www.jsb-validierung.de

More information

Why Disruptive Innovations Matter in Laboratory Diagnostics

Why Disruptive Innovations Matter in Laboratory Diagnostics Article: S. Nam.. Clin Chem 2015;61:935-937. http://www.clinchem.org/content/61/7/935.extract Guest: Spencer Nam is a Research Fellow specializing in healthcare at the Clayton Christensen Institute for

More information

FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS FOOD AND DRUG ADMINISTRATION OFFICE OF OPERATIONS OFFICE OF HUMAN RESOURCES

FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS FOOD AND DRUG ADMINISTRATION OFFICE OF OPERATIONS OFFICE OF HUMAN RESOURCES SMG 1117.37 FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS FOOD AND DRUG ADMINISTRATION OFFICE OF OPERATIONS OFFICE OF HUMAN RESOURCES DIVISION OF HUMAN RESOURCE SERVICES FOR THE OMPT

More information

Considerations When Validating Your Analyst Software Per GAMP 5

Considerations When Validating Your Analyst Software Per GAMP 5 WHITE PAPER Analyst Software Validation Service Considerations When Validating Your Analyst Software Per GAMP 5 Blair C. James, Stacy D. Nelson Introduction The purpose of this white paper is to assist

More information

Guidance for Industry

Guidance for Industry Guidance for Industry Promoting Medical Products in a Changing Healthcare Environment; I. Medical Product Promotion by Healthcare Organizations or Pharmacy Benefits Management Companies (PBMs) DRAFT GUIDANCE

More information

Eclipsys Sunrise Clinical Manager Enterprise Electronic Medical Record (SCM) and Title 21 Code of Federal Regulations Part 11 (21CFR11)

Eclipsys Sunrise Clinical Manager Enterprise Electronic Medical Record (SCM) and Title 21 Code of Federal Regulations Part 11 (21CFR11) Eclipsys Sunrise Clinical Manager Enterprise Electronic Medical Record (SCM) and Title 21 Code of Federal Regulations Part 11 (21CFR11) The title 21 code of federal regulations part 11 deals with an institutions

More information

The Importance of Good Clinical Data Management and Statistical Programming Practices to Reproducible Research

The Importance of Good Clinical Data Management and Statistical Programming Practices to Reproducible Research The Importance of Good Clinical Data Management and Statistical Programming Practices to Reproducible Research Eileen C King, PhD Research Associate Professor, Biostatistics Acting Director, Data Management

More information

Corrective and Preventive Actions

Corrective and Preventive Actions Corrective and Preventive Actions A Five Step Approach Topics to Be Covered What is CAPA? Governing authority Five steps to a good CAPA process Where companies have difficulty Example citations Recap What

More information

How To Improve Health Information Technology

How To Improve Health Information Technology The American Society For Clinical Pathology Policy Statement Health Information Technology/Informatics (Policy Number) Policy Statement: ASCP supports the implementation of standardized health information

More information

The BUILD Initiative: Next Steps in Supply Chain Innovation & Medical Device Evaluation

The BUILD Initiative: Next Steps in Supply Chain Innovation & Medical Device Evaluation The BUILD Initiative: Next Steps in Supply Chain Innovation & Medical Device Evaluation April 19, 2016 Slide 1 Overview Mercy MDEpiNet First round of MDEpiNet demonstrations MDEpiNet Public Private Partnership

More information

Establishment of a Quality Systems approach to Clinical Site Management An Overview of Standard Operating Procedures (SOPs)

Establishment of a Quality Systems approach to Clinical Site Management An Overview of Standard Operating Procedures (SOPs) Establishment of a Quality Systems approach to Clinical Site Management An Overview of Standard Operating Procedures (SOPs) Cornelia Kamp, MBA Executive Director Strategic Initiatives Tim Hackett Director

More information

INTRODUCTION. This book offers a systematic, ten-step approach, from the decision to validate to

INTRODUCTION. This book offers a systematic, ten-step approach, from the decision to validate to INTRODUCTION This book offers a systematic, ten-step approach, from the decision to validate to the assessment of the validation outcome, for validating configurable off-the-shelf (COTS) computer software

More information

A Sponsor Perspective on Validating Regulated Systems

A Sponsor Perspective on Validating Regulated Systems A Sponsor Perspective on Validating Regulated Systems From Traditional Waterfall Approaches to Agile Continuous Improvement Ø Ø PhUSE Wayne PA Single Day Event Nate Blevins, IS Business Relationship Director,

More information

QUESTIONS FOR YOUR SOFTWARE VENDOR: TO ASK BEFORE YOUR AUDIT

QUESTIONS FOR YOUR SOFTWARE VENDOR: TO ASK BEFORE YOUR AUDIT QUESTIONS FOR YOUR SOFTWARE VENDOR: TO ASK BEFORE YOUR AUDIT Heather Longden Senior Marketing Manager Waters Corporation Boston Chapter Educational Meeting June 2016 About Waters Lab Informatics Separations

More information

Panel Discussion 3. Electronic Capture of Patient-Reported Outcome (epro) Data in Clinical Trials: Regulatory Consideration

Panel Discussion 3. Electronic Capture of Patient-Reported Outcome (epro) Data in Clinical Trials: Regulatory Consideration Panel Discussion 3 Electronic Capture of Patient-Reported Outcome (epro) Data in Clinical Trials: Regulatory Consideration THIRD ANNUAL PATIENT-REPORTED OUTCOME (PRO) CONSORTIUM WORKSHOP April 4, 2012

More information

Executive Summary. Prepared By:

Executive Summary. Prepared By: 2011 Life Sciences Collaboration / Enterprise Content Management Survey Executive Summary To inquire about access to the detailed study results (67 slide presentation) please contact Steve Gens or Steve

More information

GE Healthcare MAR 1 2013

GE Healthcare MAR 1 2013 K130155 Pagel1 of 2 GE Healthcare MAR 1 2013 510(k) Summary In accordance with 21 CFR 807.92 the following summary of information is provided: Submitter: Primary Contact Person: Secondary Contact Person:

More information

October 28, 2015. Cavex Holland Bv Mr. Richard Woortman Manager Technical Services Fustweg 5 Haarlem, 2031CJ The NETHERLANDS

October 28, 2015. Cavex Holland Bv Mr. Richard Woortman Manager Technical Services Fustweg 5 Haarlem, 2031CJ The NETHERLANDS DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 28, 2015 Cavex

More information

IMEDS-Evaluation for Conducting Post-Market Safety Studies

IMEDS-Evaluation for Conducting Post-Market Safety Studies IMEDS-Evaluation for Conducting Post-Market Safety Studies Susan Gruber Troy McCall, Greg Daniel *, Nicole Spear Reagan-Udall Foundation for the FDA * Brookings Institution Big DiP USA, Boston, Massachusetts,

More information

A Cost Effective Way to De Risk Biomarker Clinical Trials: Early Development Considerations

A Cost Effective Way to De Risk Biomarker Clinical Trials: Early Development Considerations A Cost Effective Way to De Risk Biomarker Clinical Trials: Early Development Considerations Ce3, Inc. and Insight Genetics, Inc. Oncology Forum July 15, 2015 Agenda Introductions Definitions Regulations

More information

Welcome Computer System Validation Training Delivered to FDA. ISPE Boston Area Chapter February 20, 2014

Welcome Computer System Validation Training Delivered to FDA. ISPE Boston Area Chapter February 20, 2014 Welcome Computer System Validation Training Delivered to FDA ISPE Boston Area Chapter February 20, 2014 1 Background Training Conducted on April 24, 2012 Food & Drug Administration Division of Manufacturing

More information

Principal Investigator and Sub Investigator Responsibilities

Principal Investigator and Sub Investigator Responsibilities Principal Investigator and Sub Investigator Responsibilities I. Purpose To define the roles and responsibilities of Principal Investigators conducting research at GRU. II. Definition The term Principal

More information

CLINICAL DATA MONITORING PLAN (CDMoP) PROTOCOL # [0000] [TITLE]

CLINICAL DATA MONITORING PLAN (CDMoP) PROTOCOL # [0000] [TITLE] CLINICAL DATA MONITORING PLAN (CDMoP) PROTOCOL # [0000] [TITLE] CONTRACT RESEARCH ORGANIZATION SPONSOR [NAME] [ADDRESS] 1 TABLE OF CONTENTS 1. Purpose 3 2. References 3 3. Study Roles and Responsibilities

More information

Executive Intro. Outsourcing the Computer/Display portion of your program allows you to allocate resources to core competencies :

Executive Intro. Outsourcing the Computer/Display portion of your program allows you to allocate resources to core competencies : Executive Intro EmbedTek designs and manufactures purposespecific computers and integrated displays for OEM medical device and medical simulation customers. We leverage COTS technology, supported with

More information

SBA FINAL JULY 2014 RETROSPECTIVE REVIEW PLAN UPDATE. PART A Ongoing Actions

SBA FINAL JULY 2014 RETROSPECTIVE REVIEW PLAN UPDATE. PART A Ongoing Actions SBA FINAL JULY 2014 RETROSPECTIVE REVIEW PLAN UPDATE PART A Ongoing Actions /OMB CONTROL NUMBER 1. AG49 TITLE OF INITIATIVE/RULE/ICR Standards: Employee Based Size Standards for Wholesale Trade and Retail

More information

Imperative. Tim Mohn Industry Principal Sparta Systems

Imperative. Tim Mohn Industry Principal Sparta Systems Enterprise Level ChangeControl: Control: A Life Science Business Imperative Tim Mohn Industry Principal Sparta Systems Agenda GlobalChange Control: An Overview Benefits and Challenges Change Control as

More information

Subject: No. Page PROTOCOL AND CASE REPORT FORM DEVELOPMENT AND REVIEW Standard Operating Procedure

Subject: No. Page PROTOCOL AND CASE REPORT FORM DEVELOPMENT AND REVIEW Standard Operating Procedure 703 1 of 11 POLICY The Beaumont Research Coordinating Center (BRCC) will provide advice to clinical trial investigators on protocol development, content and format. Upon request, the BRCC will review a

More information

Risk management is one of the new requirements for. An Integrated Risk Assessment for Analytical Instruments and Computerized Laboratory Systems

Risk management is one of the new requirements for. An Integrated Risk Assessment for Analytical Instruments and Computerized Laboratory Systems vember 2013 Spectroscopy 28(11) 1 Focus on Quality An Integrated Risk Assessment for Analytical Instruments and Computerized Laboratory Systems A risk assessment is presented for determining the amount

More information

Developing a Practical Document Management Strategy

Developing a Practical Document Management Strategy Developing a Practical Document Management Strategy Presented by: Sean O Donovan VP, Marketing David Geddes Manager, Sales Support Agenda 1. Defining Document Management (DM ) 2. Why do I Need a Strategy?

More information

GCP - Records Managers Association

GCP - Records Managers Association GCP - Records Managers Association Guidance on the Scanning and Destruction of Paper Records 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 The introduction

More information

Final Guidance on Electronic Source Data in Clinical Investigations Promoting esource Data Capture

Final Guidance on Electronic Source Data in Clinical Investigations Promoting esource Data Capture Final Guidance on Electronic Source Data in Clinical Investigations Promoting esource Data Capture CDER Leonard Sacks, Office of Medical Policy Ron Fitzmartin, Office of Strategic Programs Jonathan Helfgott,

More information

Deliverable 6: Final Implementation Evaluation Report

Deliverable 6: Final Implementation Evaluation Report Phase 2 Contract Number: HHSF223201010017B, Order No. 22313004 Deliverable 6: Final Implementation Evaluation Report February 1, 2016 TABLE OF CONTENTS 1. EXECUTIVE SUMMARY... 1 2. PROJECT BACKGROUND AND

More information

Data Management Unit Research Institute for Health Sciences, Chiang Mai University

Data Management Unit Research Institute for Health Sciences, Chiang Mai University Data Management Unit Research Institute for Health Sciences, Chiang Mai University Clinical Data Management is the process of handling data from clinical trials. The inherent goal of any clinical data

More information

Program Evaluation of the Centers of Excellence in Regulatory Science and Innovation (CERSIs)

Program Evaluation of the Centers of Excellence in Regulatory Science and Innovation (CERSIs) Program Evaluation of the Centers of Excellence in Regulatory Science and Innovation (CERSIs) Subcommittee Update to the FDA Science Board November 18, 2015 Scott Steele, Ph.D. University of Rochester

More information

Placing Quality at the Core of Your Business Processes

Placing Quality at the Core of Your Business Processes Trusted Advisors to Healthcare and Life Science Executives Presented by Daniel R. Matlis Placing Quality at the Core of Your Business Processes Copyright 2009 Axendia, Inc. 1 1 Presented at NetApp Pharma

More information

Ubiquity of Email Security Compliance and Content Management

Ubiquity of Email Security Compliance and Content Management CIBC Global Services Ubiquity of Email Security Compliance and Content Management Stephen Dodd Director Enterprise Accounts dodd@echoworx.com 416-226-8616 404-551-3077 2006, Echoworx Corporation Agenda

More information

What is a medical device? Medical Devices: Roadmap to Market. Kathryn Klaus, Esq.

What is a medical device? Medical Devices: Roadmap to Market. Kathryn Klaus, Esq. Medical Devices: Roadmap to Market Kathryn Klaus, Esq. The last installment of Regulatory 360 discussed the FDA organization in general where it came from and a broad overview of how it operates, as well

More information

Bringing Safe and Cost Effective Products to Market

Bringing Safe and Cost Effective Products to Market Industry Solutions Life Sciences Engineering, Project Collaboration, Document Control and Facilities Management Solutions across the Life Sciences Value Chain Industry Solutions Life sciences companies

More information

Strategic Benefits of an Online Clinical Data Repository

Strategic Benefits of an Online Clinical Data Repository Strategic Benefits of an Online Clinical Data Repository 5625 Dillard Drive Suite 205 Cary, NC 27518 www.pharsight.com Strategic Benefits of an Online Clinical Data Repository Contents Introduction 2 The

More information

Overview. Disasters are happening more frequently and Recovery is taking on a different perspective.

Overview. Disasters are happening more frequently and Recovery is taking on a different perspective. Overview Disasters are happening more frequently and Recovery is taking on a different perspective. Defining a Disaster/Disaster Recovery Basic requirements in preparing for a disaster The role of Quality

More information

Total Product Lifecycle Solutions from NSF Health Sciences Medical Devices

Total Product Lifecycle Solutions from NSF Health Sciences Medical Devices Total Product Lifecycle Solutions from NSF Health Sciences Medical Devices Experts in medical device quality systems, compliance, regulatory affairs, auditing and training www.nsf.org The Right People.

More information

Cellular Therapy Liaison Meeting 10 September 2009 BECS. M. Allene Carr-Greer, MT(ASCP)SBB Director, Regulatory Affairs AABB

Cellular Therapy Liaison Meeting 10 September 2009 BECS. M. Allene Carr-Greer, MT(ASCP)SBB Director, Regulatory Affairs AABB Cellular Therapy Liaison Meeting 10 September 2009 BECS M. Allene Carr-Greer, MT(ASCP)SBB Director, Regulatory Affairs AABB Definition from October 2007 draft guidance BECS Validation In the User s Facility

More information

Guidance for Industry and Food and Drug Administration Staff

Guidance for Industry and Food and Drug Administration Staff Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff Guidance for Industry and Food and Drug Administration Staff Document

More information

Oracle Security. Joyce Peng Senior Product Manager, Life Sciences Oracle Corporation Yao-chun.Peng@oracle.com

Oracle Security. Joyce Peng Senior Product Manager, Life Sciences Oracle Corporation Yao-chun.Peng@oracle.com Oracle Security Joyce Peng Senior Product Manager, Life Sciences Oracle Corporation Yao-chun.Peng@oracle.com Agenda Security Challenges 21 CFR Part 11 HIPAA Oracle Security Security Challenges Privacy

More information

Re-energizing the Practice of Leadership for the Public Good Public Sector Core Leadership Practices Paradoxes of Leadership

Re-energizing the Practice of Leadership for the Public Good Public Sector Core Leadership Practices Paradoxes of Leadership Re-energizing the Practice of Leadership for the Public Good Public Sector Core Leadership Practices Paradoxes of Leadership In July of 2001 a group of representatives from the National Security Agency

More information

Risk-Based Validation of Commercial Off-the-Shelf Computer Systems

Risk-Based Validation of Commercial Off-the-Shelf Computer Systems Risk-Based Validation of Commercial Off-the-Shelf Computer Systems Published by Advanstar Communications in Journal of Validation Technology May 2005, Vol. 11, No. 3 Supplied by (*) www.labcompliance.com

More information

MEDICAL DEVICE QUALITY SYSTEMS MANUAL: A SMALL ENTITY COMPLIANCE GUIDE. First Edition

MEDICAL DEVICE QUALITY SYSTEMS MANUAL: A SMALL ENTITY COMPLIANCE GUIDE. First Edition HHS Publication FDA 97-4179 MEDICAL DEVICE QUALITY SYSTEMS MANUAL: A SMALL ENTITY COMPLIANCE GUIDE First Edition (Supersedes the Medical Device Good Manufacturing Practices Manual) Andrew Lowery, Judy

More information

Product Lifecycle Management in the Medical Device Industry. An Oracle White Paper Updated January 2008

Product Lifecycle Management in the Medical Device Industry. An Oracle White Paper Updated January 2008 Product Lifecycle Management in the Medical Device Industry An Oracle White Paper Updated January 2008 Product Lifecycle Management in the Medical Device Industry PLM technology ensures FDA compliance

More information

OECD and US GLP Applications. Del W. Huntsinger. BASF, Reserach Triangle Park, USA del.huntsinger@basf.com

OECD and US GLP Applications. Del W. Huntsinger. BASF, Reserach Triangle Park, USA del.huntsinger@basf.com OECD and US GLP Applications Del W. Huntsinger BASF, Reserach Triangle Park, USA del.huntsinger@basf.com Agenda Brief Overview US GLPs OECD GLPS Similarities Differences Looking Forward OECD and US GLP

More information

Brainreader ApS February 4, 2015 C/O Mette Munch QA Consultant Skagenvej 21 Egaa, 8250 DENMARK

Brainreader ApS February 4, 2015 C/O Mette Munch QA Consultant Skagenvej 21 Egaa, 8250 DENMARK DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 Brainreader ApS February

More information

Siemens Industry Automation Division

Siemens Industry Automation Division Siemens Division Pharmaceutical and Life Science Industries Key Trends in the Pharmaceutical Industry Regulation Economic pressure Risk based approach More patient protection Anti counterfeit E- submission

More information

Good Clinical Practice 101: An Introduction

Good Clinical Practice 101: An Introduction Good Clinical Practice 101: An Introduction Presented by: Lester Jao Lacorte, MD Medical Officer Commissioner s Fellow Division of Bioresearch Monitoring Office of Compliance Center for Devices and Radiological

More information