1 Z.A.S. Archive- and informationsmanagement Presentation at SAG Scientific Archivists Group Spring Conference in Basel 11 June 2010 Electronic Archiving in a GXP-regulated environment Author: Bernd Mohnsame
2 Greeting Good morning ladies and gentlemen, My name is Bernd Mohnsame. I am CEO of Z.A.S. Zentral Archiv Service GmbH located near to Berlin in Neubrandenburg, Germany. Since 1994 we have been providing archiving services in the field of record and information management, in particular for the pharmaceutical industry. Our clients are from Germany for the most part, though we do also have more and more clients from neighboring European countries.
3 What is Z.A.S. doing? Our scopes of business Konservierung
4 Introduction When I was asked in fall of last year whether I would be willing to give a presentation at this year s SAG Spring Conference on the topic of electronic archiving in a GXPregulated environment" in English, I did not know what I was getting myself into. For one my English is a bit rusty so please bear with me. -If you don t understand what I am saying, please do me a favor and DO NOT let me know- On the other hand, this topic is so complex that anyone trying to cover it in a 30-minute presentation is doomed to failure. Thus today I will concentrate on a small area that I assume will be of interest to you.
5 Structure My presentation is structured as follows: 1. Report on the stage of work of the working group on Digitization of documents in a GXP-regulated environment 2. Digitization processes three real-life examples 3. Scan on demand as an alternative to the complete digitization of archives? 4. Presentation film of the record- and informationmanagement service provider
6 Report Members DGGF, the German Society for Good Research Practice, and more specifically its division on archiving, set up a working group consisting of 6 members about one year ago. Its task was to draft a position paper entitled: Digitization of documents in a GXP-regulated environment. The working group consists of six members: Name Company 1 Torsten Dunker Biomedion 2 Klaus Lindow Bayer Healthcare 3 Bettina Quernheim sanofi-aventis 4 Bernd Mohnsame Z.A.S. Zentral Archiv Service 5 Britta Krusemeyer Covance 6 Michael Bursian Grünenthal
7 Report Tasks This working group defined the following tasks for its work: 1. Summary and analysis of existing regulatory framework conditions, based on GLP, GCP and GMP 2. Conclusion of recommendations for electronic archiving based on this existing regulatory framework 3. Design of a GXP-compliant digitization process 4. Description of prerequisites required for eliminating the need to keep originals (destruction of originals).
8 Report Facts Even though this working group has met fairly regularly every 4 to 8 weeks, this position paper has not been finalized yet which is why, at this point in time, I can only give you a quick snapshot of the current stage of work. Putting together all facts on the regulatory framework has been completed in the meantime.
9 Report For that we collected source texts from various pieces of legislation, organizations and authorities, such as: Sources Bund-Länder-Arbeitsgruppe GLP, a German working group that brings together representatives from the federal and the state level FDA (Food and Drug Administration) EMEA (European Medicines Agency) OECD (Organization for Economic Co-operation & Development) ICH (International Conference on Harmonization) 21 CFR Part 11, 58, 210&211, 820 German Ordinance on the Production of Pharmaceuticals and Active Substances (AMWHV) Chemicals Act
10 Report Analyze The next step was to allocate these sources texts to GLP, GCP and GMP and to summarize and analyze their material statements on "electronic archiving". By now and based on this analysis of source texts we have concluded recommendations on a GXP-compliant digitization process.
11 Report Requirements These recommendations relate to the following areas: Filing and the handing over of records from the competent department to the archiver Compliance Management Conservational preparation of files Completeness and totality Integrity and authenticity Indexing Pagination Preparation of documents Digitalization- technology, hardware and software Requirements on personnel used Requirements on procedure Validation and change control Access control Back-up and disaster recovery procedures Training of administrators and users Audit trial Analysis of the economic efficiency of electronic archiving versus archiving originals File format Electronic archiving system Archiving media
12 Report Controversials Based on the defined requirements the working group drafted a proposal for a GXP-compliant digitization process that I will talk about in greater detail in part 3 of my presentation. As part of the process of coming up with a GXP-compliant digitization process we realized that the various regulatory conditions that need to be taken into account, seem to leave a lot of room for interpretation at first glance. This led to many (and) controversial discussions during the meetings of this working group. Up until today the following aspects are subject to controversial discussion: Quality assurance in the digitization process Requirements on a digital certified /true copy Approach to and scope of an audit trial Under which requirements is it permissible to dispose originals, and if so, at what point?
13 Report Conclusion Of crucial importance is clearly the ability to dispose of originals. It has in principle been laid down by law and is permissible if And it is exactly this if that we are concerned about. For example: Non of the analyzed regulations mentioned above requires the liability to submit documents by original. Contra wise, it is explicit mentioned that it is legal to use certified copy s. But there is nowhere a link to find who say s how an electronic certified copy has to be arranged and what kind of process therefore is needed. Until these issues of the ifs and when's, and buts have not been defined and become legally binding, there will be some risk left for companies that, already at this stage, decide to archive documents only digitally.
14 Report Advantages The advantages of electronic archiving versus the traditional archiving of originals are obvious and could be summarized as follows: Availability of information at any time and anywhere Speed of access Security of access Accuracy of access Simple versioning Back-up and disaster recovery Saving of space In the pharmaceutical industry stakeholders agree that the electronic imaging of business processes is desirable.
15 Alternatives Thus please allow me to raise the question whether there are any alternatives that could be used in the meantime until we have such a regulation providing for a legally binding provision on electronic archiving as the only type of archive. The alternative we are looking for should still allow us to use the advantages of electronic archiving, without having to do with any reversal of the legal certainty. On this note I would like to show you three real-life examples that ZAS is currently implementing with various clients. But in all examples currently we still retain the originals.
16 Alternatives 3 Examples O u t h o u s e Three general ways for digitalization data documents files General I n h o u s e retrospective Hybridsystem Extern prospective electronic archive The following Examples are based on a retrospective digitalization process. But it should be the aim to come to a prospective way.
17 Alternatives Scanning documents to create a simple working copy Example 1 Simple working copy In a global work environment the goal of creating a simple working copy is to provide for the easiest possible handling of information, in particular the exchange of information. Original documents are still physically archived in line with the legal obligation to retain data. No original documents are taken from the archive. In case of a request for a document only the digital document is provided.
18 Alternatives Example 1 This procedure results in intended, positive side effects, such as the additional protection of the original documents in view of their totality, completeness, and integrity. In addition by retaining the originals, revision- and manipulation-safety is provided for as well. Simple working copy Having an electronic working copy also provides some protection in case the original accidentally got lost. From my point of view scanning documents to create a simple working copy can be realized by an quite easily configured process and is thus particularly suitable for archives of old files.
19 Alternatives Scanning documents to create a qualified working copy Example 2 Qualified working copy The intention when creating a qualified working copy is to provide a duplicate that mirrors the content of the original document 1:1. It can then be passed on as a working copy as I just described while the original documents remain physically stored. The qualified working copy is different from a simple working copy in that the completeness and integrity of the digitized document are provided for. This is also why all originals need to be checked for that before starting the digitization process.
20 Alternatives Example 2 A log file will afterwards provide information on what documents are contained in what folders and how many pages each of these documents have. Every page needs to be paginated. Qualified working copy As part of digitization the scanning operator confirms with his electronic signature that all pages have been digitized with the information mirroring 100% of the original. I believe scanning documents to create a qualified working copy is particularly suitable for completed studies or trials, in particular if these were completed by subcontractors.
21 Compliance Scanning documents to create a certified copy Example 3 Electronic certified copy When creating elektronic certified copies, the intention is to use digitization to be able to do without paper documents. The digitization process needs to be trustworthy and manipulation-safe to provide for this purpose. Every scanning process needs to be adapted to the needs and circumstances of the respective company Scanning documents to create a certified copy is thus particularly suitable for creating an electronic image of ongoing business processes.
22 Compliance Example 3 Apart from the requirements that have already been determined for simple and qualified copies, compliance with 21 CFR Part 11 needs to provide for at least the following aspects: Electronic certified copy Complete description of the entire process Validation of technology, hardware and software used, including change control Access control on the logical and physical level Proof of training for administrators and users Evidence of 4-eye-principle for checking individual pages and indexing using two separate advanced electronic signatures Scanning in PDF/A format including blank back pages SOP for operating an electronic archive Audit trial after converting every single document
23 Compliance Process Example 3 Electronic certified copy
24 Compliance Process Example 3 Electronic certified copy
25 Practice Scan on Demand In the end the question whether, from a legal and business perspective, electronic archiving is preferred over the paperbased archiving of originals is a decision that needs to be company-specific. The physical archiving of originals with a service provider that offers "scan on demand" is surely an alternative that, from a commercial perspective, is worth thinking about. The external archiving specialist stores your originals and archives them physically in accordance with GXP. Originals are indexed in consultation with the competent departments. In addition every original is allocated a barcode that identifies the position in the archive and an identification number. In this way every archived medium can be definitely identified by metadata's.
26 Practice Scan on Demand This metadata`s consisting of the index and the identification number is made accessible to you via a web-based archive database, a platform through which you can conveniently request digital copies of originals. After receiving a request for a document, the archiving service takes out the originals from the physical archive, scans them and provides you with the digitized version, ideally within about 60 minutes, via , FTP server or through a web archive. The scan on demand service of an external archiving company combines the desired advantages of electronic archiving with a high degree of economic efficiency while providing for legal security and is thus a valuable alternative. Such a solution can be installed within only three months!
27 Practice Service Provider External service providers generally look at your information management from the outside and can thus provide solutions on an as-need basis. Digitizing your originals, with archiving capacities that grow with that, and their certified security standards make external service providers the solution of choice for many pharmaceutical companies. Obviously these companies will first have to make their information management a priority and include it in their long-term corporate strategy.
28 Thank you for your attention Bernd Mohnsame mobil: +49 (0) 176/ Contact: Z.A.S. Zentral Archiv Service GmbH Justus-von-Liebig Str Neubrandenburg Tel.: 0395/ Fax: 0395/ Departments: Z.A.S. Neubrandenburg Z.A.S. Magdeburg Z.A.S. Berlin Z.A.S. Frankfurt a. M.
29 For those of you who are interested in the position paper of our working group, I will pass a sheet of paper around where you can put down your contact details. I hope to be able to send you the completed position paper by autumn If we still have time, let s watch the ZAS presentation film. Film on! Film eng..wmv Gez Bernd Mohnsame Z.A.S. Zentral Archiv Service GmbH Justus von Liebig Str Neubrandenburg Germany Mail:
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: email@example.com http://www.jsb-validierung.de
From paper to electronic data Bioindustrypark, October 10, 2013 Dr Alessandra Grande Ivrea GxP Test Facility QA Manager, Head Global BMT QA Research & Development Quality Assurance MerckSerono RBM Outline
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
PHLEXGLOBAL WHITE PAPER PhlexEarchive: The Right Solution for Electronic Archiving of TMF Content Presented By: Gill Gittens Head of Marketing Phlexglobal Ltd. firstname.lastname@example.org Table of Contents
M-FILES QUALITY MANAGEMENT SYSTEM SIGNING OPTIONS QMS BUILT-IN DIGITAL SIGNING M-Files QMS contains simple and effective built-in digital document signing. M-Files QMS built-in digital signatures are designed
GLP vs GMP vs GCP Dominique Pifat, Ph.D., MBA The Biologics Consulting Group email@example.com Common Misconception Good Laboratory Practices 1) A quality system concerned with the organizational process
PKI Adoption Case Study (for the OASIS PKIA TC) ClinPhone Complies with FDA Regulations Using PKIbased Digital Signatures PKI Project Title Digital Signatures for ClinPhone Organisation concerned ClinPhone
Industry Solutions Life Sciences Engineering, Project Collaboration, Document Control and Facilities Management Solutions across the Life Sciences Value Chain Industry Solutions Life sciences companies
MHRA GMP Data Integrity Definitions and Guidance for Industry Introduction: Data integrity is fundamental in a pharmaceutical quality system which ensures that medicines are of the required quality. This
OMCL Network of the Council of Europe QUALITY ASSURANCE DOCUMENT PA/PH/OMCL (08) 69 3R Full document title and reference Document type VALIDATION OF COMPUTERISED SYSTEMS Legislative basis - CORE DOCUMENT
TITOLO SLIDE Testo Slide Testo Slide Testo Slide Clinical database/ecrf validation: effective processes and procedures IV BIAS ANNUAL CONGRESS Padova September, 26 th 2012 PQE WORKSHOP: What's new in Computerized
Validated SaaS LMS SuccessFactors Viability Executive Summary SuccessFactors has a long history of working with validated organizations and has brought this expertise to their validated SaaS LMS package.
A Guide to Archiving of Electronic Records 18th February 2014 A Guide to Archiving of Electronic Records The Scientific Archivists Group (SAG) formed a Working Party to develop guidance to assist in the
White paper Streamlining the drug development lifecycle with Adobe LiveCycle enterprise solutions Using intelligent PDF documents to optimize collaboration, data integrity, authentication, and reuse Table
An Overview of Clinical Archiving Russell Joyce Records & Information Manager Objectives To understand the Historical context of archiving Importance of archiving Regulatory & legal frameworks Archiving
MHRA GMP Data Integrity Definitions and Guidance for Industry Introduction: Data integrity is fundamental in a pharmaceutical quality system which ensures that medicines are of the required quality. This
White Paper No 01 I December 2010 Implementation of 21 CFR Part 11 in the epmotion Software Electronic records and electronic signatures in the regulated environment of the pharmaceutical and medical device
The Challenge Handling a lot of paper documents Handling a lot of paper documents is becoming increasingly challenging in a company. There are two typical scenarios. A lot of documents are received, created
GLP Records Storage and Retrieval Cindy Green BBS UNITED, ALEX HAYDEN/GETTY IMAGES GLP Topics addresses topics associated with good laboratory practice requirements. We intend this column to be a useful
Reprinted from PHARMACEUTICAL ENGINEERING The Official Magazine of ISPE July/August 2011, Vol. 31 No. 4 www.ispe.org Copyright ISPE 2011 The ISPE GAMP Community of Practice (COP) provides its interpretation
Cloud Services Archiving Audit-proof Available anytime, anywhere Compliant with international Directives and Laws www.signamus.com Secure Storage With the Secure Storage you can retain your data securely,
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
Scotland s Commissioner for Children and Young People Records Management Policy 1 RECORDS MANAGEMENT POLICY OVERVIEW 2 Policy Statement 2 Scope 2 Relevant Legislation and Regulations 2 Policy Objectives
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
3109 W. Dr. Martin Luther King, Jr. Blvd., Suite 250 Tampa, FL 33607 USA Tel: 813/960-2105 Fax: 813/264-2816 www.ispe.org Risk-Based Approach to 21 CFR Part 11 The 21 CFR Part 11 regulation is a comprehensive
Full Compliance for and EU Annex 11 With the regulation support of Contents 1. Introduction 2 2. The regulations 2 3. FDA 3 Subpart B Electronic records 3 Subpart C Electronic Signatures 9 4. EU GMP Annex
White paper inforouter in the Life Sciences Industry: 21 CFR Part 11 Compliance Overview of 21 CFR Part 11 The final version of the 21 CFR Part 11 regulation released by the FDA in 1997 provides a framework
Is it okay to destroy the paper source records? Are there any exceptions? Strategies for Developing a Document Imaging & Electronic Retention Program How do we ensure the program will stand up in court?
Regulatory Asset Management: Harmonizing Calibration, Maintenance & Validation Systems 800.982.2388 1 Introduction Calibration, maintenance and validation activity, despite operating within the same department
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
Software Manual Part IV: FDA 21 CFR part 11 Version 2.20 OPTIMA Software Manual Part IV: FDA 21 CFR part 11 BMG LABTECH This manual was designed to guide OPTIMA users through the software features related
Meeting the FDA s Requirements for Electronic Records and Electronic Signatures (21 CFR Part 11) Executive Summary...3 Background...4 Internet Growth in the Pharmaceutical Industries...4 The Need for Security...4
September 2, 2003 Risk-Based Validation of Computer Systems Used In FDA-Regulated Activities Purpose This document provides a summary of the requirements relating to use of computer-based systems in activities
GENERAL DISTRIBUTION OCDE/GD(95)115 OECD SERIES ON PRINCIPLES OF GOOD LABORATORY PRACTICE AND COMPLIANCE MONITORING NUMBER 10 GLP CONSENSUS DOCUMENT THE APPLICATION OF THE PRINCIPLES OF GLP TO COMPUTERISED
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
Reference Number: UHB 139 Version Number: 2 Date of Next Review: 14 Apr 2018 Previous Trust/LHB Reference Number: N/A DATA MANAGEMENT IN CLINICAL TRIALS: GUIDELINES FOR RESEARCHERS Introduction and Aim
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
Quality is Advantage Microsoft Exchange Server 2013 Configuring Course duration: 32 academic hours Exam Code: 70-662 This course is designed for novice IT specialists, who wish to master maintenance and
Computer System Validation - It s More Than Just Testing Introduction Computer System Validation is the technical discipline that Life Science companies use to ensure that each Information Technology application
Core Solutions of Microsoft Exchange Server 2013 MOC 20341 Course Outline Module 1: Deploying and Managing Exchange Server 2013 This module explains how to plan and perform deployment and management of
University Hospitals Birmingham NHS Foundation Trust CONTROLLED DOCUMENT RDS014 Research Related Archiving CATEGORY: CLASSIFICATION: PURPOSE Controlled Document Number: Version Number: 1 Controlled Document
DISCOVER OUR SEGMENT GLP AND REGULATORY/ SCIENTIFIC ARCHIVING OUR FOCUS We offer a complete archiving concept for all regulatory needs (regulatory/scientific archiving and GLP-compliant storage). Our clients
Back to index of articles Qualification of Computer Networks and Infrastructure R.D.McDowall McDowall Consulting Validation of computerised systems generally focuses on the providing documented evidence
AGIT Guidelines for the Archiving of Electronic Raw Data 1 / 13 GOOD LABORATORY PRACTICE (GLP) GUIDELINES FOR THE ARCHIVING OF ELECTRONIC RAW DATA IN A GLP ENVIRONMENT Working Group on Information Technology
Qualification Guideline June 2013 Disclaimer: This document is meant as a reference to Life Science companies in regards to the Microsoft O365 platform. Montrium does not warrant that the use of the recommendations
TRANSACTION MANAGEMENT IN ARIZONA AN ARIZONA ASSOCIATION OF REALTORS WHITE PAPER OCTOBER 2015 PURPOSE The purpose of this White Paper is to serve as a guideline to provide Arizona brokers information and
FRAMEWORK FOR THE DESTRUCTION OF PAPER Version v1.0 24 June 2012 Created through the DIA Document and Records Management (DRM) Special Interest Area Community (SIAC) TABLE OF CONTENTS Position Statement...
Gap Analysis - Checklist 21 CFR Part 11 Electronic Records & Signatures his document is a proposal and starting point only. he type and extent of documentation depends on the process environment. he proposed
Information Management Advice 18 - Managing records in business systems Part 1: Checklist for decommissioning business systems Introduction Agencies have systems which hold business information, such as
Page 1 of 10 Date Last Revision: Feb 12/08 POLICY STATEMENT AND PURPOSE The County of Elgin provides employees, elected officials, and other organizations and individuals with access to computer and network
Considerations for Management of Laboratory Data 2003 Scientific Computing & Instrumentation LIMS Guide, November 2003 Michael H Elliott Drowning in a sea of data? Nervous about 21 CFR Part 11? Worried
Scanning and Tossing Requirements for Scanning and the Destruction of Paper Based Records Overview I want to go paperless! Can I scan and toss? What are the rules and requirements about imaging? What are
Appendix F, Section 2 Web-Enabled Data Repository: Test Phase Agency: Department of Children, Families and Learning (DCFL) TIS Evaluation Meeting Date: 2 June 1999 State Archives Staff: Mary Klauda, Shawn
Guide 4 Keeping records to meet corporate requirements This guidance has been produced in support of the good practice recommendations in the Code of Practice on Records Management issued by the Lord Chancellor
Clinical Data Management (Process and practical guide) Dr Nguyen Thi My Huong WHO/RHR/RCP/SIS Training Course in Sexual and Reproductive Health Research Geneva 2012 OUTLINE Clinical Data Management CDM
GE02-H I Archiving of Clinical Trial Documents Version: Final 01 Valid from: 28.12.2004 Replaces Version: Draft 09 of: 15.11.2004 Author: A. Ripkens-Reinhard Date Author signature Review: FG-QS Date FG
STANDARD OPERATING PROCEDURE FOR DATA RETENTION SOP Number: GCP DM 505.02 Version Number & Date: 2 nd Version; 25 Apr 2013 Superseded Version Number & Date (if applicable): 1 st Version; 17 June 2010 Effective
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
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
Discard Create Inactive Life Cycle of Records Current Retain Use Semi-current Records Management Policy April 2014 Document title Records Management Policy April 2014 Document author and department Responsible
Declaration of Conformity 21 CFR Part 11 SIMATIC WinCC flexible 2007 SIEMENS AG Industry Sector Industry Automation D-76181 Karlsruhe, Federal Republic of Germany E-mail: firstname.lastname@example.org Fax: +49
Ordinance on Specialised Waste Management Companies (Entsorgungsfachbetriebeverordnung - EfbV) *) of 10 September 1996 The Federal Government, having heard the parties concerned, and pursuant to Article
Washington Cities Insurance Authority ESB 5964 Part Three: Records Retention Presented by, Michael F. Connelly Attorney at Law PS Mfc.email@example.com 509.723.3883 1 RECORDS MANAGEMENT LAWS Statutes:
Digitale arkiver - Vedligeholdelse, tilgængelighed og forskning 13. maj 2014 på Rigsarkivet Archive strategy for electronic records Peter Fæster Nielsen, Novo Nordisk 13. May 2014 Peter Fæster Nielsen,
Records Management Policy Responsible Officer Chief Operating Officer Approved by Vice-Chancellor Approved and commenced April, 2014 Review by April, 2017 Relevant Legislation, Ordinance, Rule and/or Governance
Updating Your Skills from Microsoft Exchange Server 2003 or Exchange Server 2007 to Exchange Server 2010 Course 10165; 5 Days, Instructor-led Course Description There are two main reasons for the course.
The Impact of 21 CFR Part 11 on Product Development Product development has become an increasingly critical factor in highly-regulated life sciences industries. Biotechnology, medical device, and pharmaceutical
Document Imaging Services Conversion of Paper Based Records into Electronic Documents and Images. Document Preparation, Scanning, Indexing and E-Delivery Services THE SCANNING OF SPECIFIC DOCUMENTS REPRESENTS
Table of Contents Validating Enterprise Systems: A Practical Guide Foreword 1 Introduction The Need for Guidance on Compliant Enterprise Systems What is an Enterprise System The Need to Validate Enterprise
Provincial Saskatchewan Archives R of Saskatchewan Basic Records Management Practices for Saskatchewan Government* Provincial Archives of Saskatchewan (306) 787-0734 firstname.lastname@example.org www.saskarchives.com
Protecting Official Records as Evidence in the Cloud Environment Anne Thurston Introduction In a cloud computing environment, government records are held in virtual storage. A service provider looks after
1 2 3 15 June 2015 EMA/INS/GCP/636736/2012 Good Clinical Practice Inspectors Working Group (GCP IWG) 4 5 6 7 Reflection paper on GCP compliance in relation to trial master files (paper and/or electronic)
CLINICAL DATA MONITORING PLAN (CDMoP) PROTOCOL #  [TITLE] CONTRACT RESEARCH ORGANIZATION SPONSOR [NAME] [ADDRESS] 1 TABLE OF CONTENTS 1. Purpose 3 2. References 3 3. Study Roles and Responsibilities
Phlexglobal Whitepaper PhlexEview: Transforming Costly Paper Processes into Value Driven Compliance Presented By: Karen Roy Chief Business Development Officer Email: KRoy@phlexglobal.com Phlexglobal Inc.
CASE STUDY Bringing benefits & added value with e-archiving NV Logistics e-freight www.iata.org 1/11 1. Acknowledgments IATA would like to take the opportunity to thank NV Logistics and particularly his
John D. Bonam Disaster Recovery Architecture Session # 2841 LEARNING POINTS Understand the known Traditional approach to Backup Recovery of the BusinessObjects Environment Understand the need for Disaster
Document and Data Control An Integral Component of Quality Management Companies that produce products with rigorous quality requirements face numerous challenges associated with meeting quality objectives
Virtual Infrastructure Security 2 The virtual server is a perfect alternative to using multiple physical servers: several virtual servers are hosted on one physical server and each of them functions both
S E P T E M B E R 2 0 1 3 Comply or Perish: The biggest challenges of Life Sciences companies today are maintaining a robust product pipeline and reducing time to market while complying with an increasing
GMP Rules and Guidelines in 2013 for Computer System Validation / Computerises Systems / Electronic Records and Signatures/ IT Infrastructure and Application Compliance: What is the correct title of this
Managing Risk in Clinical Research Dr Martha J Wrigley R&D Manager Senior Visiting Fellow University of Surrey Aim of the session To explore the risks associated with clinical research and understand how