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

Size: px
Start display at page:

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

Transcription

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

2 1.0 Commercial in Confidence 16-Aug of 6 Document Approval Name Role Date Signature David Brown Author Document History Version Author Date Description 1.0 David Brown 16-Aug-2006 First draft.

3 1.0 Commercial in Confidence 16-Aug of 6 Table of Contents 1 INTRODUCTION Purpose Scope Definitions References Procedure Main Document Control Elements Changes after Formal Issue Validation Documentation Distribution Document Effectivity Distribution Lists Document Management... 6

4 1.0 Commercial in Confidence 16-Aug of 6 1 INTRODUCTION 1.1 Purpose 1.2 Scope This document details the procedures for the management of documents related to the validation process. Department/Section: All This standard operating procedure applies to all documents directly related to the validation process. 1.3 Definitions None. 1.4 References None.

5 1.0 Commercial in Confidence 16-Aug of 6 2 Procedure Document control consists of the following: 1. Main document control features. 2. Changes after first formal issue. 3. Distribution lists and copy numbers. 2.1 Main Document Control Elements The main document control elements are: 1. Document Reference the main reference for the document. Allocated on the first draft being written and never modified. 2. Author the author of the current issue of the document 3. Date of issue the issue date of the document. 4. Issue the issue of the document 5. Document Approval the names of the author, the checker of the document and the approver of the document. The checker of the document is the one who verifies that all review actions have been performed. 6. Document History A list of all issues of the documents, the dates and reasons for the change. 2.2 Changes after Formal Issue After a document has been placed under formal change control (Issue 1.0), any subsequent changes to the documents should be made under the validation control process and any changes to the document tracked. Once the document has passed through a successful review the any tracked changes can be removed prior to the next formal issue. Sometimes, due to the limitations of Microsoft Word and/or complexity of the document this may not be possible.

6 1.0 Commercial in Confidence 16-Aug of Validation Documentation Distribution Document Effectivity When a copy of a document related to the validation process is printed its effectivity must be shown in the footer of the document. The footer of the document must state clearly the following: The date the copy was printed or created in the case of electronic documents. The name of the person issued with the copy of the document. The number of days the document is effective for (usually no longer that 90 days). The statement This is a copy of an original document Distribution Lists Occasionally some documents will require distribution lists and associated copy numbers. These will be maintained with the document history and approval sections and should contain the name of the individual, their organisation and an associated copy number. 2.4 Document Management Validation documents must be managed securely to ensure their integrity. Validation documents may be scanned and stored in TIFF image file format or stored on microfilm to provide a backup of the paper originals. If electronic documents are regarded as master documents in the validation process a system and/or processes that comply with FDA 21 CFR Part 11 must be used to ensure their integrity and that appropriate electronic signatures are used.

Configuration Management SOP

Configuration Management SOP 1.0 Commercial in Confidence 08-Aug-2006 1 of 7 Configuration Management SOP Document No: SOP_0113 Prepared by: David Brown Date: 09-Aug-2006 Version: 1.0 1.0 Commercial in Confidence 08-Aug-2006 2 of

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

Update on Monitoring & Electronic Medical Records at UCSF

Update on Monitoring & Electronic Medical Records at UCSF Clinical and Translational Science Institute / CTSI at the University of California, San Francisco Update on Monitoring & Electronic Medical Records January 10, 2012 at UCSF Danusia Filipowski, MD Director,

More information

H11S 04 (CFACC9) Use systems and technology during customer contact in a contact centre

H11S 04 (CFACC9) Use systems and technology during customer contact in a contact centre Overview What this standard is about Contact centres use a variety of systems and technology to handle contacts with customers. Using that technology is one of the main skills for handling a full range

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

PKI Adoption Case Study (for the OASIS PKIA TC) ClinPhone Complies with FDA Regulations Using PKIbased Digital Signatures

PKI Adoption Case Study (for the OASIS PKIA TC) ClinPhone Complies with FDA Regulations Using PKIbased Digital Signatures 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

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

M-FILES QUALITY MANAGEMENT SYSTEM SIGNING OPTIONS

M-FILES QUALITY MANAGEMENT SYSTEM SIGNING OPTIONS 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

More information

AMERICAN ACADEMY OF ORTHOPAEDIC SURGEONS GUIDELINE PROCESS PROCEDURE FOR DOCUMENT CONTROL OF EVIDENCE BASED GUIDELINES

AMERICAN ACADEMY OF ORTHOPAEDIC SURGEONS GUIDELINE PROCESS PROCEDURE FOR DOCUMENT CONTROL OF EVIDENCE BASED GUIDELINES AMERICAN ACADEMY OF ORTHOPAEDIC SURGEONS GUIDELINE PROCESS PROCEDURE FOR DOCUMENT CONTROL OF EVIDENCE BASED GUIDELINES DOCUMENT CONTROL OF EVIDENCE-BASED GUIDELINES 1.0 PURPOSE The purpose of this document

More information

Quality Management Plan Template

Quality Management Plan Template Quality Management Plan Template Project Name: U.S. Department of Housing and Urban Development October, 2010 Quality Management Plan Template (V1.0) Notes to the Author [This document is a template of

More information

Full Compliance Contents

Full Compliance Contents 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

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

Risk-Based Validation of Computer Systems Used In FDA-Regulated Activities

Risk-Based Validation of Computer Systems Used In FDA-Regulated Activities 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

More information

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

Content Management for Courts. Improve court operations by reducing costs, speeding response times and simplifying paper-intensive processes

Content Management for Courts. Improve court operations by reducing costs, speeding response times and simplifying paper-intensive processes Content Management for Courts Improve court operations by reducing costs, speeding response times and simplifying paper-intensive processes An Innovation in Records Management for Your Judicial Processes

More information

Gap Analysis of the Change Control Process The History of a Transformed Change Control System

Gap Analysis of the Change Control Process The History of a Transformed Change Control System Gap Analysis of the Change Control Process The History of a Transformed Change Control System Juan Alcazar Quality Systems Carolina, PR Content Introduction Gap Analysis Phases to perform a Gap Analysis

More information

Title: COFL-FF-EP-4.4.5-1 Control of Documents Procedure

Title: COFL-FF-EP-4.4.5-1 Control of Documents Procedure Title: COFL-FF-EP-4.4.5-1 Control of Documents Procedure Verification Originator Approved Issued Initials ADS ST ST Date 8/15/2014 12/05/2014 12/15/2014 Person responsible: ESMS Coordinator Area of application:

More information

Scanning and Tossing. Requirements for Scanning and the Destruction of Paper Based Records

Scanning and Tossing. Requirements for Scanning and the Destruction of Paper Based Records 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

More information

Social Media Editor Salary and Job Description

Social Media Editor Salary and Job Description Job Title: Web & Social Media Editor Salary and Pay Band: 23,598-27, 039 per annum plus excellent benefits Hours: 35 Job Holder: New post Team (Directorate/Nation): New Media Team Location: MSNC Manager:

More information

Guideline for E-mail Services

Guideline for E-mail Services Guideline for E-mail Services Under the Policy on Information Technology, the Vice-President and Provost is authorized to establish guidelines for information technology services at the University of Toronto.

More information

Role of eclinical Systems in FDA Regulated Studies. Jonathan S. Helfgott

Role of eclinical Systems in FDA Regulated Studies. Jonathan S. Helfgott Role of eclinical Systems in FDA Regulated Studies Presented by: Jonathan S. Helfgott Operations Research Analyst Office of Scientific Investigations Disclaimer The contents of this presentation are my

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

Discussion Paper on the Validation of Pharmacovigilance Software provided via SaaS

Discussion Paper on the Validation of Pharmacovigilance Software provided via SaaS Discussion Paper on the Validation of Pharmacovigilance Software provided via SaaS June 2012 K Edmonds Page 1 of 10 Page 2 of 10 Contents 1. Introduction... 4 2. Quality Statement ISO 9001:2008... 4 3.

More information

Contribute to performance management in a contact centre

Contribute to performance management in a contact centre Overview What this standard is about Efficiency and effectiveness in contact centres rely on close management of performance. With defined business objectives, clear procedures and many repeated transactions

More information

References to Computer and Software in FDA s CGTPs (Final Rule and Draft Guidance) for HCT/Ps Preamble to the CGTP Final Rule

References to Computer and Software in FDA s CGTPs (Final Rule and Draft Guidance) for HCT/Ps Preamble to the CGTP Final Rule Preamble to the CGTP Final Rule Pages 68626-68627 Computers Proposed 1271.160(e) would require establishments to validate computer software used as part of manufacturing or tracking or for maintaining

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

How To Control A System

How To Control A System Department of the Interior Security Control Standard Awareness and Training April 2011 Version: 1.1 Signature Approval Page Designated Official Bernard J. Mazer, Department of the Interior, Chief Information

More information

Top Ten Tips for Selecting the Right Digital Signature Solution for Your Organization

Top Ten Tips for Selecting the Right Digital Signature Solution for Your Organization The Digital Signature Company Top Ten Tips for Selecting the Right Digital Signature Solution for Your Organization 101001001 001101001 001011100 010110100 110001001 000101001 0010 Top Ten Tips for Selecting

More information

Contribute to resource plan development in contact centre operations

Contribute to resource plan development in contact centre operations Overview What this standard is about Contact centre activity is subject to constant variation in volume. Monitoring of activity levels and types of contact provides vital information for resource planning.

More information

Compliance Matrix for 21 CFR Part 11: Electronic Records

Compliance Matrix for 21 CFR Part 11: Electronic Records Compliance Matrix for 21 CFR Part 11: Electronic Records Philip E. Plantz, PhD, Applications Manager David Kremer, Senior Software Engineer Application Note SL-AN-27 Revision A Provided By: Microtrac,

More information

STANDARD OPERATING PROCEDURE FOR DATA RETENTION

STANDARD OPERATING PROCEDURE FOR DATA RETENTION 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

More information

Making SOP Training More Effective

Making SOP Training More Effective By David Peterson, Director, GMP and Quality Systems, UL EduNeering SOPs are critical to efficient operations, quality control and regulatory compliance. This paper reviews best practices for the Life

More information

Site visit inspection report on compliance with HTA minimum standards. London School of Hygiene & Tropical Medicine. HTA licensing number 12066

Site visit inspection report on compliance with HTA minimum standards. London School of Hygiene & Tropical Medicine. HTA licensing number 12066 Site visit inspection report on compliance with HTA minimum standards London School of Hygiene & Tropical Medicine HTA licensing number 12066 Licensed under the Human Tissue Act 2004 for the storage of

More information

Document Change Control

Document Change Control Document Change Control for Quality & Regulatory Compliance Quality and Compliance Solutions Document Control Software for Microsoft Windows Document Change Control Improve efficiency and enforce consistency

More information

How To Manage An Electronic Standard Operating Procedure

How To Manage An Electronic Standard Operating Procedure AGIT Management of electronic SOPs 1 / 14 GOOD LABORATORY PRACTICE (GLP) GUIDELINES FOR THE MANAGEMENT OF ELECTRONIC STANDARD OPERATING PROCEDURES (SOPs) IN A GLP ENVIRONMENT Working Group Information

More information

Guidance for Industry COMPUTERIZED SYSTEMS USED IN CLINICAL TRIALS

Guidance for Industry COMPUTERIZED SYSTEMS USED IN CLINICAL TRIALS Guidance for Industry COMPUTERIZED SYSTEMS USED IN CLINICAL TRIALS U.S. Department of Health and Human Services Food and Drug Administration Center for Biologic Evaluation and Research (CBER) Center for

More information

POSITION DESCRIPTION AND DUTY STATEMENT

POSITION DESCRIPTION AND DUTY STATEMENT POSITION DESCRIPTION AND DUTY STATEMENT DUTY STATEMENT AND POSITION DESCRIPTION Position Title: Reporting to: Department: Classification: ICT Technician (Support) ICT Manager Information and Communication

More information

Some Example Laboratory. Working Procedure

Some Example Laboratory. Working Procedure s Page: 1 of 6 Some Example Laboratory Working Procedure Author: Someone Smith Reviewed and Approved By: DATE s Page: 2 of 6 1.0 Subject Writing s. 2.0 Purpose The purpose of this procedure is to describe

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

Nova Southeastern University Standard Operating Procedure for GCP. Title: Electronic Source Documents for Clinical Research Study Version # 1

Nova Southeastern University Standard Operating Procedure for GCP. Title: Electronic Source Documents for Clinical Research Study Version # 1 Nova Southeastern University Standard Operating Procedure for GCP Title: Electronic Source Documents for Clinical Research Study Version # 1 SOP Number: OCR-RDM-006 Effective Date: August 2013 Page 1 of

More information

Tender for the scanning & data capture of archive microfilms Supplier Background Questionnaire

Tender for the scanning & data capture of archive microfilms Supplier Background Questionnaire Tender for the scanning & data capture of archive microfilms Supplier Background Questionnaire 1 of 15 INTRODUCTION This document must be completed in addition to the main tender submission and proposals

More information

FORMATTING OVERVIEW GUIDELINES FOR YOUR THESIS OR DISSSERTATION FOR SUBMISSION TO THE GRADUATE SCHOOL

FORMATTING OVERVIEW GUIDELINES FOR YOUR THESIS OR DISSSERTATION FOR SUBMISSION TO THE GRADUATE SCHOOL FORMATTING OVERVIEW GUIDELINES FOR YOUR THESIS OR DISSSERTATION FOR SUBMISSION TO THE GRADUATE SCHOOL NOTE: Please be sure to check with your advisor for specific guidelines for submitting your thesis/dissertation.

More information

11.I In-process control Authors: Dr. Christian Gausepohl / Paolomi Mukherji / Update 07

11.I In-process control Authors: Dr. Christian Gausepohl / Paolomi Mukherji / Update 07 In-process control In-process control Authors: Dr. Christian Gausepohl / Paolomi Mukherji / Update 07 Here you will find answers to the following questions: What are the in-process control tasks? Where

More information

Quality Management System Process/ Management Review

Quality Management System Process/ Management Review Directorate in charge: Process concerned: Process owner: Executive Directorate Quality Management System Process/ Management Review Quality Section Manager Véronique Magnier Purpose and Scope of the :

More information

Back to index of articles. Qualification of Computer Networks and Infrastructure

Back to index of articles. Qualification of Computer Networks and Infrastructure 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

More information

21 CFR Part 11 Compliance Using STATISTICA

21 CFR Part 11 Compliance Using STATISTICA 21 CFR Part 11 Compliance Using STATISTICA Last Updated: April 2003 This document was updated to reflect the FDA s latest guidance (released February, 2003) and the withdrawal of previous guidance.! STATSOFT

More information

IT Professional Standards. Information Security Discipline. Sub-discipline 605 Information Security Testing and Information Assurance Methodologies

IT Professional Standards. Information Security Discipline. Sub-discipline 605 Information Security Testing and Information Assurance Methodologies IT Professional Standards Information Security Discipline Sub-discipline 605 Information Security Testing and Information Assurance Methodologies December 2012 Draft Version 0.6 DOCUMENT REVIEW Document

More information

CoSign for 21CFR Part 11 Compliance

CoSign for 21CFR Part 11 Compliance CoSign for 21CFR Part 11 Compliance 2 Electronic Signatures at Company XYZ Company XYZ operates in a regulated environment and is subject to compliance with numerous US government regulations governed

More information

Good Research Practice

Good Research Practice Page 1 of 8 The Royal Veterinary College Introduction Preface Good Research Practice Funding bodies need to be assured of the quality and validity of research they fund and ensure their contractors are

More information

Departmental Policy Departmental Procedure Instructions/Forms. UCVM DIAGNOSTIC SERVICES UNIT Document Control Procedure

Departmental Policy Departmental Procedure Instructions/Forms. UCVM DIAGNOSTIC SERVICES UNIT Document Control Procedure hi Departmental Policy Departmental Procedure Instructions/Forms UCVM DIAGNOSTIC SERVICES UNIT Document Control Procedure Classification Information Management Approval Authority Diagnostic Services Unit

More information

U 09 Remote Access Policy

U 09 Remote Access Policy Dartmoor National Park Authority U 09 Remote Access Policy June 2010 This document is copyright to Dartmoor National Park Authority and should not be used or adapted for any purpose without the agreement

More information

Manchester City Council Report for Information. Managing Attendance (Real Time Absence Reporting)

Manchester City Council Report for Information. Managing Attendance (Real Time Absence Reporting) Manchester City Council Report for Information Report to: Subject: Overview and Scrutiny Human Resources Subgroup - 25 January 2011 Managing Attendance (Real Time Absence Reporting) Report of: Assistant

More information

A Complete Drug Stability Program. Stability Lab Information Manager SL IM

A Complete Drug Stability Program. Stability Lab Information Manager SL IM A Complete Drug Stability Program Stability Lab Information Manager SL IM SLIM is a Fully Validated, World-Class Stability LIMS. SLIM combines the ease of use of browser style user interface and industry

More information

Archive strategy for electronic records Peter Fæster Nielsen, Novo Nordisk 13. May 2014

Archive strategy for electronic records Peter Fæster Nielsen, Novo Nordisk 13. May 2014 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,

More information

Support team use of contact centre systems and technology

Support team use of contact centre systems and technology Overview What this standard is about Contact centres use a variety of systems and to handle contacts with customers. Agents and trainees make use of the basic features of those systems sometimes with some

More information

SOLAARsecurity. Administrator Software Manual. 010508 Issue 2

SOLAARsecurity. Administrator Software Manual. 010508 Issue 2 SOLAARsecurity Administrator Software Manual 9499 400 40011 010508 Issue 2 2008. All rights reserved. SOLAAR House, 19 Mercers Row, Cambridge CB5 8BZ.United Kingdom. Telephone +44 (0) 1223 347400, Fax

More information

Demographics QUESTIONS COMMENTS

Demographics QUESTIONS COMMENTS DOI SURVEY Name: Bureau: Department: Location: Telephone: Email: Date of Interview: Defining Requirements for an Electronic Records Management Solution A series of fact finding questions will be presented

More information

50 Tips for Closing Year End with Confidence. Sheri Carney sheri@resgroup.com

50 Tips for Closing Year End with Confidence. Sheri Carney sheri@resgroup.com 50 Tips for Closing Year End with Confidence Sheri Carney sheri@resgroup.com Prep Tips 1) Attend Year End Procedures in Microsoft Dynamics GP class at The Resource Group» Dec 11 th or Dec 20 th» www.resgroup.com/training

More information

When the template is complete, the whole Product Description document can be printed and approved.

When the template is complete, the whole Product Description document can be printed and approved. HOW TO USE THIS TEMPLATE: Introduction The template reflects the steps set out in the PRINCE2 Method and is designed to prompt the Project Manager and help in the creation of the Product Description. The

More information

How Industry Can Partner with FDA in Defining a Risk- Based Monitoring Program

How Industry Can Partner with FDA in Defining a Risk- Based Monitoring Program How Industry Can Partner with FDA in Defining a Risk- Based Monitoring Program Presenter: Jan Holladay Pierre, MPH Quality Principal Leader DynPort Vaccine Company LLC, A CSC Company This presentation

More information

Electronic Records: An Open Discussion AATB s 31st AnnualMeeting Boston Marriott Copley Place September17, 2007. Scott Brubaker, CTBS

Electronic Records: An Open Discussion AATB s 31st AnnualMeeting Boston Marriott Copley Place September17, 2007. Scott Brubaker, CTBS Electronic Records: An Open Discussion AATB s 31st AnnualMeeting Boston Marriott Copley Place September17, 2007 Scott Brubaker, CTBS Overview The AATB has received requests to develop minimum, uniform

More information

Part III Administrative, Procedural, and Miscellaneous. 26 CFR 601.203: Offers in Compromise (Also Part I, 7122; 301.7122-1) Rev.

Part III Administrative, Procedural, and Miscellaneous. 26 CFR 601.203: Offers in Compromise (Also Part I, 7122; 301.7122-1) Rev. Part III Administrative, Procedural, and Miscellaneous 26 CFR 601.203: Offers in Compromise (Also Part I, 7122; 301.7122-1) Rev. Proc 2003-71 SECTION 1. PURPOSE The purpose of this revenue procedure is

More information

MEDICAL RECORD FEES UNDER HIPAA AND ILLINOIS LAW

MEDICAL RECORD FEES UNDER HIPAA AND ILLINOIS LAW MEDICAL RECORD FEES UNDER HIPAA AND ILLINOIS LAW *JANUARY 2013 UPDATE* Under Illinois law the amount a physician can charge for copies of medical records is limited. This maximum amount includes a handling

More information

Introduction. Editions

Introduction. Editions Introduction TRAIN TRACK Employee Training Management Software gives you the tools you need to make sure employee training requirements are met. Assign required training for groups or individuals. Easily

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

Capital Works Construction Project. [Insert Project Title] [Insert Sponsoring Agency]

Capital Works Construction Project. [Insert Project Title] [Insert Sponsoring Agency] Capital Works Construction Project [Insert Project Title] [Insert Sponsoring Agency] Detailed Business Case Commercial - in- Confidence [Insert Date] Table of Contents 1. Executive Summary --------------------------------------------------------------------------------------------------

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

How To Ensure Your School Is Safe Online

How To Ensure Your School Is Safe Online Ivy Road Primary School Policy for e-safety Updated - 2014 1. Introduction Pupils interact with the internet and other communications technologies such as mobile phones on a daily basis. The exchange of

More information

FRAMEWORK FOR THE DESTRUCTION OF PAPER

FRAMEWORK FOR THE DESTRUCTION OF PAPER 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...

More information

QUALITY CONTROL AND QUALITY ASSURANCE IN CLINICAL RESEARCH

QUALITY CONTROL AND QUALITY ASSURANCE IN CLINICAL RESEARCH QUALITY CONTROL AND QUALITY ASSURANCE IN CLINICAL RESEARCH Martin Valania, Executive Director, Corporate QA and Compliance Introduction Pharmaceutical companies recognize the benefits of carefully managing

More information

Document Scanning Considerations

Document Scanning Considerations Document Scanning Considerations Peter Goodrich Goodrich Associates 391 Mt. Sequoia Place Clayton, CA 94517 (925) 673-1475 petergoodrich@sbcglobal.net Facts about Our Business Files 90% of your company's

More information

Updating your Outlook Profile

Updating your Outlook Profile Updating your Outlook Profile The following steps will allow you to remove your existing mail profile and update Outlook with your new mailbox. Note: Remember to follow the two steps before this: 1. Login

More information

21 CFR Part 11 Deployment Guide for Wonderware System Platform 3.1, InTouch 10.1 and Historian 9.0

21 CFR Part 11 Deployment Guide for Wonderware System Platform 3.1, InTouch 10.1 and Historian 9.0 Deployment Guide 21 CFR Part 11 Deployment Guide for Authors: Invensys Operations Management and TSD (Total System Design, an Optimation Company) Table of Contents by Section 1 Before you Begin...............................................................................................

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

Patch Management Procedure. Andrew Marriott andrew.marriott@fylde.gov.uk 01253 658578 PATCH MANAGEMENT PROCEDURE.DOCX Version: 1.1

Patch Management Procedure. Andrew Marriott andrew.marriott@fylde.gov.uk 01253 658578 PATCH MANAGEMENT PROCEDURE.DOCX Version: 1.1 Title: Patch Management Andrew Marriott andrew.marriott@fylde.gov.uk 01253 658578 PATCH MANAGEMENT PROCEDURE.DOCX Version: 1.1 Contents 1. Introduction... 4 2. Objectives... 4 3. Context... 4 4. Responsibility...

More information

CfD Company and User Registration

CfD Company and User Registration CfD Company and User Registration Support Guide 6 th October 2014 National Grid Electricity Transmission Page 1 Table of Contents Introduction... 3 EMR Company Registration Information... 3 EMR Company

More information

Standard Operating Procedure Information Security Compliance Requirements under the cabig Program

Standard Operating Procedure Information Security Compliance Requirements under the cabig Program Page 1 of 9 Pages Standard Operating Procedure Information Security Compliance Requirements under the cabig Program This cover sheet controls the layout and components of the entire document. Issued Date:

More information

Paperless Lending Made Easy: Streamlining the Loan Management Process. Presented by: David Geddes Manager, Sales Operations

Paperless Lending Made Easy: Streamlining the Loan Management Process. Presented by: David Geddes Manager, Sales Operations Paperless Lending Made Easy: Streamlining the Loan Management Process Presented by: David Geddes Manager, Sales Operations Agenda 1. Business Challenges with Paper-Based Lending 2. Ideal Paperless Lending

More information

Information Technology &

Information Technology & Effective Date: 02 Sep 2014 Page 1 of 5 REVISION HISTORY Revision Date Author Description of Changes 30 Jul 2014 Helen Miletic Manager Quality Assurance Research Compliance and Quality Assurance Made revisions

More information

Firewall Access Request Form

Firewall Access Request Form SECTION 1 TO BE COMPLETED BY THE APPLICANT By completing the below information the requestor/applicant acknowledges and agrees that he/she has read, understood and will comply with the following: CHECK

More information

PI - Request for Medical Records

PI - Request for Medical Records PI - Request for Medical Records Purpose: Describe the initiation of the PI medical record request process. Identification of Roles: IME-Program Integrity (PI) is responsible for the initiation and completion

More information

Vendor/Supplier Guide. Preparing and submitting invoices

Vendor/Supplier Guide. Preparing and submitting invoices Vendor/Supplier Guide Preparing and submitting invoices California Institute of Technology Payment Services Department 1200 E. California Blvd., Suite 101, MC 103-6, Pasadena, CA 91125 626-395-8900 - Fax:

More information

PRIVACY IMPACT ASSESSMENT

PRIVACY IMPACT ASSESSMENT Name of System/Application: LAN/WAN PRIVACY IMPACT ASSESSMENT U. S. Small Business Administration LAN/WAN FY 2011 Program Office: Office of the Chief Information Officer A. CONTACT INFORMATION 1) Who is

More information

Security Control Standard

Security Control Standard Department of the Interior Security Control Standard Security Assessment and Authorization January 2012 Version: 1.2 Signature Approval Page Designated Official Bernard J. Mazer, Department of the Interior,

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

Regulated Documents. A concept solution for SharePoint that enables FDA 21CFR part 11 compliance when working with digital documents

Regulated Documents. A concept solution for SharePoint that enables FDA 21CFR part 11 compliance when working with digital documents Regulated Documents A concept solution for SharePoint that enables FDA 21CFR part 11 compliance when working with digital documents Contents Life science industry challenges Regulated Documents our service

More information

The View from The Shard

The View from The Shard The View from The Shard The View is situated at the top of The Shard, the tallest building in Western Europe on floors 68, 69 and 72. The experience is a high tech and multi-sensory journey, with exhilarating

More information

FE3A 04 (CFACSD11) Lead a Team to Improve Customer Service

FE3A 04 (CFACSD11) Lead a Team to Improve Customer Service This Unit has the following Elements: D11.1 Plan and organise the work of a team. D11.2 Provide support for team members. D11.3 Review performance of team members. Unit Summary This Unit is part of the

More information

REQUEST FOR DOCUMENT IMAGING OF PUBLIC RECORDS

REQUEST FOR DOCUMENT IMAGING OF PUBLIC RECORDS ARS 41-1516 A. Each agency of this state or any of its political subdivisions may implement a program for the production or reproduction by photography or other method of reproduction on film, microfiche,

More information

Manual 074 Electronic Records and Electronic Signatures 1. Purpose

Manual 074 Electronic Records and Electronic Signatures 1. Purpose 1. Purpose The purpose of this document is to provide an interpretation of FDA 21 CFR Part 11, Electronic Records; Electronic Signatures (ER/ES) and to provide guidance for acceptable practices in the

More information

SEMETS3-72 Performing computer system security assessments for engineering software

SEMETS3-72 Performing computer system security assessments for engineering software Performing computer system security assessments for engineering Overview This unit identifies the competences you need to perform a computer system security assessment, in accordance with approved procedures.

More information

Brown County Information Technology Aberdeen, SD. Request for Proposals For Document Management Solution. Proposals Deadline: Submit proposals to:

Brown County Information Technology Aberdeen, SD. Request for Proposals For Document Management Solution. Proposals Deadline: Submit proposals to: Brown County Information Technology Aberdeen, SD Request for Proposals For Document Management Solution Proposals Deadline: 9:10am, January 12, 2016 Submit proposals to: Brown County Auditor 25 Market

More information

ISO 13485:2003 U.S. QSR (21 CFR 820) Quality Systems Manual

ISO 13485:2003 U.S. QSR (21 CFR 820) Quality Systems Manual Insert Your Company Name Here ISO 13485:2003 U.S. QSR (21 CFR 820) Quality Systems Manual Street Address City, State Zip This manual can be used as a template in developing your ISO 13485 Quality Manual.

More information

Job Description. Project Officer. New post (12 months funding) MS Society Cymru. Wales (home based) Director, MS Society Cymru.

Job Description. Project Officer. New post (12 months funding) MS Society Cymru. Wales (home based) Director, MS Society Cymru. Job Title: Project Officer Salary and Pay Band: C3 22,073-24,572 Hours: 35 Job Holder: Team (Directorate/ Nation): Location: New post (12 months funding) MS Society Cymru Wales (home based) Manager: Direct

More information

How To Set Up Your Email

How To Set Up Your Email How To Set Up Your Email Contents Page Microsoft Outlook 1 Outlook Express 6 7 Webmail (this is for those who do not use an email programme) 12 Windows Live Mail 22 Mozilla Thunderbird 26 Windows Mail

More information

Implementing Title 21 CFR Part 11 (Electronic Records ; Electronic Signatures) in Manufacturing Presented by: Steve Malyszko, P.E.

Implementing Title 21 CFR Part 11 (Electronic Records ; Electronic Signatures) in Manufacturing Presented by: Steve Malyszko, P.E. Implementing Title 21 CFR Part 11 (Electronic Records ; Electronic Signatures) in Manufacturing Presented by: Steve Malyszko, P.E. President & CEO Agenda Introduction Who is Malisko Engineering? Title

More information

Microsoft Dynamics GP. Electronic Signatures

Microsoft Dynamics GP. Electronic Signatures Microsoft Dynamics GP Electronic Signatures Copyright Copyright 2006 Microsoft Corporation. All rights reserved. Complying with all applicable copyright laws is the responsibility of the user. Without

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

ESSEX FIRE AUTHORITY. Internal Audit Progress Report. Audit Sub-Committee Meeting: April 2012

ESSEX FIRE AUTHORITY. Internal Audit Progress Report. Audit Sub-Committee Meeting: April 2012 ESSEX FIRE AUTHORITY Internal Audit Progress Report Audit Sub-Committee Meeting: April Essex Fire Authority CONTENTS Section Page 1 Introduction 1 2 Final reports 1 3 Key Findings from Internal Audit Work

More information

Management Liability Policy Employment practices liability only

Management Liability Policy Employment practices liability only February 2014 edition Management Liability Policy Employment practices liability only Who can use this proposal form This proposal form is only for: UK registered companies, charities or associations with

More information