Departmental Policy Departmental Procedure Instructions/Forms. UCVM Diagnostic Services Unit Document Control Procedure
|
|
- Evelyn Lynch
- 5 years ago
- Views:
Transcription
1 hi Departmental Policy Departmental Procedure Instructions/Forms UCVM Diagnostic Services Unit Document Control Procedure Classification Information Management Approval Authority Diagnostic Services Unit Manager Implementation Authority Diagnostic Services Unit Manager Effective Date May 15, 2012 Table of Contents Purpose 1 Scope 2 Definitions 3 Procedures 4 Responsibilities 5 Instructions/Forms 6 Related Procedures 7 History 10 Latest Revision May 15, 2012 Purpose 1 To describe the process used by the UCVM Diagnostic Services Unit (DSU) to manage controlled documents. This includes the creation, revision, approval, storage, distribution, retirement, archiving, and destruction of controlled documents. Scope 2 This procedure applies to DSU personnel. Definitions 3 In this procedure: a) Approved Master Document is an original signed document. The approval signature indicates approval for issuance and use. An Approved Master Document may be reproduced for distribution by the DSU manager or designate. b) Change Control refers to a formal process used to ensure that changes to a Controlled Document are introduced in a controlled and coordinated manner. c) Controlled Copy is a photocopy of an Approved Master Document prepared by the DSU manager or designate for distribution to appropriate areas. The copy bears a copy number on the front page and is marked Do Not Copy. d) Controlled Document refers to Standard Operating Procedures (SOP) and forms that have controlled distribution and are subject to Change Control procedures. e) Issuance is the date that a Controlled Document is finalized and issued to a department. The document does not become effective for use until the Effective Date. The electronic version is the official version of these procedures. Page 1 of 6
2 f) Effective Date is the date that a document becomes effective for use. The time difference between the Issuance and Effective Dates is to ensure adequate time for personnel training prior to procedure implementation. g) Revision History is the listing of the documented changes made to a Controlled Document. Procedures General a) Photocopying a Master Document by anyone other than the DSU Manager or designate is prohibited. b) Photocopying a Controlled Copy of a Standard Operating Procedure by anyone other than the DSU Manager or designate is prohibited. c) Controlled forms may be copied by all DSU staff for the purpose of recording information. d) All Controlled Documents are subject to revision control. Only the current version is to be used and use of any obsolete document is prohibited. e) Controlled Documents may not be provided to persons who are not employed in the DSU without prior authorization by the DSU Manager or designate. 4.2 New Documents a) An individual initiates a new document as described in SOP Q Change Control Procedure. b) The DSU Manager or designate: 1) Assigns a unique number to the document being created as described in SOP Q-0002 Identification of Controlled Documents. A new document will have a revision number of 00. 2) Records the title and the document number in the electronic document inventory log. 4.3 Revisions to Existing Documents a) An individual initiates revision of an existing document or requests removal of an obsolete document from circulation as described in the SOP Q-0004 Change Control Procedure. b) The DSU Manager or designate: 1) Provides an electronic copy of the approved document for editing if requested. 2) Provides a hard copy for editing if requested. The hard copy will be clearly marked as an uncontrolled copy. 3) Attaches the edited copy to the Change Control Record prior to closing out the Change Control. 4.4 Approval of New or Revised Documents The electronic version is the official version of these procedures. Page 2 of 6
3 a) The DSU Manager or designate: 1) Performs final formatting and editing as required for standard DSU or University of Calgary format, consistency, spelling, grammar, etc. 2) Creates a hard copy Master Document by printing the finalized copy. 3) Forwards the Master Document to the author for signature. NOTE: University of Calgary-format SOPs have a separate approval form for the approval signature. 4) Signs as the approver. 5) Assigns the effective date to the document once it is approved. 6) Saves the finalized electronic document to the appropriate approved documents folder. 7) Updates the electronic document inventory log. 4.5 Document History File (DHF) and Inventory Update a) The DSU manger or designate prepares a Document History File for each controlled Standard Operating Procedure and form as follows: 1) Labels a file folder with the document number, but not the revision number. 2) Attaches a Document History Log (FQ-0001A) and Document Distribution Record (FQ-0001C) to the left side of the Document History File. 3) Updates the information on the Document History File each time a document is processed according to an approved Change Control. 4) Attaches the Change Control for that document to the right side of the Document History File. 5) Inserts the approved new or revised Master Document into the Document History File without securing it. 6) Stores the Document History File in a secure location. 4.6 Document Distribution a) The DSU manger or designate: 1) Determines the quantity of copies required. 2) Prepares Controlled Copies for distribution by copying the Master Document(s). 3) Labels each page of the controlled copy with Do Not Copy. 4) Sequentially assigns a copy number on each controlled copy made. 5) Prepares and attaches a Procedure Training Record (FQ- The electronic version is the official version of these procedures. Page 3 of 6
4 0001B) to each Standard Operating Procedure (plus associated forms) being issued. 6) Records the relevant information as applicable for that document on the Document Distribution Record already installed in the Document History File. 7) Ensures that the controlled copies are transferred to the relevant area. NOTE: DSU SOPs using the University of Calgary procedure format include a line in the footer stating that The electronic version is the official version of these procedures. Because all controlled documents in circulation within the DSU are copy controlled, the DSU paper copies of controlled copies will also be considered to be official versions. 4.7 Procedure Training Record (PTR) a) Individuals are responsible for completing the PTR issued with the relevant procedures. b) Managers and area supervisors ensure that all personnel who are required to follow the procedure have read the SOP and signed the associated PTR prior to performing the procedure. 4.8 Document Retirement, Archival and Destruction a) The DSU manager or designate: 1) Logs the return of each document on the appropriate Document Distribution Record. 2) Destroys all obsolete Controlled Copies of documents. 3) Stamps or writes RETIRED over the Effective Date of the superseded Approved Master Document in the Document History File. 4) Adds the returned Procedure Training Record for each controlled document to the Document History File for that document. 5) Strikes through the remaining space on the Document History Log, dates and initials the entry. 6) Stamps or marks the Document History File label on the folder as ARCHIVED if the document is no longer needed and the entire Document History File is being taken out of circulation. 7) Stores the archived Document History Files in a designated, secure file location. 8) Moves the electronic copy of the document to the folder for retired documents. 9) Updates the electronic document inventory log. 4.9 Periodic Document Review The electronic version is the official version of these procedures. Page 4 of 6
5 a) Every approved Controlled Document is subject to review by the owner/authoring department at a minimum of once every two years. b) The DSU manager or designate initiates the review process by preparing a Document Review Form (FQ-0001D) and forwarding it to the authoring/owning department. c) An individual with appropriate knowledge and experience reviews the document and determines whether or not it is fit-foruse in its current state. The review includes: 1) Any controlled forms associated with the document. 2) Verification that all information including the procedure, material lists, and referenced documents are current and relevant. 3) Recording the assessment in the appropriate sections of the form. d) If no changes are required, the reviewer places a check mark beside the appropriate box on the Document Review Form, signs and dates the form and returns it to the DSU manager or designate. e) If the document requires revision, the reviewer initiates a Change Control Record (FQ-0004B) and returns it with the signed and dated Document Review Form. f) The DSU manager or designate files the completed Document Review Form in the Document History File 4.10 Storage of Current and Archived Documents a) Approved current and archived Master Documents are stored in an appropriate secure location to prevent accidental damage, loss or unauthorized removal. Responsibilities The DSU manager or designate is responsible for: a) Assigning numbers to new and revised documents. b) Final formatting and editing of draft documents. c) Ensuring correct Change Control procedures are followed. d) Assigning Effective Dates to new and revised documents. e) Controlling electronic versions of new and revised DSU documents. f) Creating a Document History File for each Controlled Document. g) Updating the document inventory log. h) Distribution, retirement, archiving, and destruction of Controlled Documents. i) Storage of current and archived Master Documents. j) Forwarding electronic versions and sign-off sheets for new or revised documents using the University of Calgary format to the University of Calgary Access and Privacy Coordinator. 5.2 Managers and supervisors are responsible for: The electronic version is the official version of these procedures. Page 5 of 6
6 a) Ensuring that personnel are trained and have read the Standard Operating Procedure and signed the Procedure Training Record prior to performing the procedure. 5.3 Individuals using controlled documents are responsible for a) Verifying that the current version of the document is used. b) Determining the need for new procedures, revisions or deletion of documents in their areas. Instructions/Forms 6 FQ-0001A Document History Log FQ-0001B Procedure Training Record FQ-0001C Document Distribution Record FQ-0001D Document Review Form FQ-0004B Change Control Record Related Procedures 7 Q-0002 Identification of Controlled Documents Q-0003 Preparation of Controlled Documents Q-0004 Change Control Procedure History 10 Revision # Change Control # Summary of Change 00 CC New document. 01 CC Changes to description of how to archive Document History Files. Minor text edits. The electronic version is the official version of these procedures. Page 6 of 6
Standard Operating Procedure. Preparation, Review and Approval of Clinical Research Standard Operating Procedures and Work Instructions
Standard Operating Procedure SOP number: SOP full title: SOP-JRO-35-001 Preparation, Review and Approval of Clinical Research Standard Operating Procedures and Work Instructions SOP effective: 11 July
More informationNEWCASTLE CLINICAL TRIALS UNIT STANDARD OPERATING PROCEDURES
SOP details SOP title: Document Control SOP number: GE-003 SOP category: General Version number: 03 Version date: 17 April 2018 Effective date: 17 May 2018 Revision due date: 17 May 2021 NEWCASTLE CLINICAL
More informationSTANDARD OPERATING PROCEDURE
STANDARD OPERATING PROCEDURE Title Reference Number Document Version Control SOP-QMS-002 Version Number 2 Issue Date 08 th Dec 2015 Effective Date 22 nd January 2016 Review Date 22 nd January 2018 Author(s)
More informationISSUE N 1 MAJOR MODIFICATIONS. Version Changes Related Release No. PREVIOUS VERSIONS HISTORY. Version Date History Related Release No.
ISSUE N 1 MAJOR MODIFICATIONS Version Changes Related Release No. 01 First issue. 2.8.0 PREVIOUS VERSIONS HISTORY Version Date History Related Release No. N/A N/A N/A N/A APPROVAL TABLE Signatures below
More informationDOCUMENT REVISION HISTORY PAGE. 90A0001 AK 2 of 25. Revision History Of Document
DOCUMENT REVISION HISTORY PAGE Document Number: Rev: Page: Title: 90A0001 AK 2 of 25 Documentation Control Rev Revision History Of Document CO Number Description of Change Author Effective Date FI ---
More informationUNCONTROLLED WHEN PRINTED
Procedure: Control of Documents Facilities and Services Division 1. SUMMARY 1.1. This procedure defines the requirements for the creation, numbering, review, approval, distribution, use and revision of
More informationCONTROL OF DOCUMENTS
CONTROL OF DOCUMENTS Name Signature Date Prepared: Quality Management Representative 14/6/2010 Approved By : Director 14/6/2010 Issue No:1 Revision: 0 Issue Date: 14 June 2010 Page 2 of 14 Table of Contents
More informationGoddard Procedures and Guidelines
Goddard Procedures and Guidelines DIRECTIVE NO.: GPG 1410.1 APPROVED BY Signature: Original Signed by NAME: A. V. Diaz TITLE: Director Responsible Office: 230/Logistics Management Division Title: DIRECTIVES
More informationSparta Systems TrackWise Digital Solution
Systems TrackWise Digital Solution 21 CFR Part 11 and Annex 11 Assessment February 2018 Systems TrackWise Digital Solution Introduction The purpose of this document is to outline the roles and responsibilities
More informationGOVERNMENT OF ONTARIO COMMON RECORDS SERIES TRANSITORY RECORDS
GOVERNMENT OF ONTARIO COMMON RECORDS SERIES December 8, 2008 These series govern the retention and disposal of the transitory records (in paper, electronic, and other formats) created and received by the
More informationSupersedes Policy previously approved by TBM
Document Title: Email Policy Pages Document Type: Policy 6 No. Of Scope: Government of Newfoundland and Labrador (GNL) Trim # DOC15481/2009 Revision ( # ) 27 Treasury Board Approval ( # ) TBM2009-298 Supersedes
More informationSystem Assessment Report Relating to Electronic Records and Electronic Signatures; Final Rule, 21 CFR Part 11
Page 1 /16 System Assessment Report Relating to Electronic Records and Electronic Signatures; Final Rule, 21 CFR Part 11 System: Touch Control for Titrando (Software version 5.840.0150) Page 2 /16 1 Procedures
More informationSparta Systems TrackWise Solution
Systems Solution 21 CFR Part 11 and Annex 11 Assessment October 2017 Systems Solution Introduction The purpose of this document is to outline the roles and responsibilities for compliance with the FDA
More informationSparta Systems Stratas Solution
Systems Solution 21 CFR Part 11 and Annex 11 Assessment October 2017 Systems Solution Introduction The purpose of this document is to outline the roles and responsibilities for compliance with the FDA
More informationCOMPUTER & INFORMATION TECHNOLOGY CENTER. Information Transfer Policy
COMPUTER & INFORMATION TECHNOLOGY CENTER Information Transfer Policy Document Controls This document is reviewed every six months Document Reference Document Title Document Owner ISO 27001:2013 reference
More informationPart 11 Compliance SOP
1.0 Commercial in Confidence 16-Aug-2006 1 of 14 Part 11 Compliance SOP Document No: SOP_0130 Prepared by: David Brown Date: 16-Aug-2006 Version: 1.0 1.0 Commercial in Confidence 16-Aug-2006 2 of 14 Document
More informationRecords Management and Retention
Records Management and Retention Category: Governance Number: Audience: University employees and Board members Last Revised: January 29, 2017 Owner: Secretary to the Board Approved by: Board of Governors
More informationNEWCASTLE CLINICAL TRIALS UNIT STANDARD OPERATING PROCEDURES
SOP details SOP title: Protocol development SOP number: TM 010 SOP category: Trial Management Version number: 03 Version date: 16 December 2016 Effective date: 16 January 2017 Revision due date: 16 January
More informationSpark Arrestors OCTOBER The electronic pdf version of this document found through is the officially binding version
STANDARD FOR CERTIFICATION No. 2.9 TYPE APPROVAL PROGRAMME 5-779.70-1 Spark Arrestors OCTOBER 2011 The electronic pdf version of this document found through http://www.dnv.com is the officially binding
More informationSystem Assessment Report Relating to Electronic Records and Electronic Signatures; 21 CFR Part 11. System: tiamo (Software Version 2.
Page 1 /15 System Assessment Report Relating to Electronic Records and Electronic Signatures; 21 CFR Part 11 System: tiamo (Software Version 2.5) Page 2 /15 1 Procedures and Controls for Closed Systems
More informationIntegration of Agilent OpenLAB CDS EZChrom Edition with OpenLAB ECM Compliance with 21 CFR Part 11
OpenLAB CDS Integration of Agilent OpenLAB CDS EZChrom Edition with OpenLAB ECM Compliance with 21 CFR Part 11 Technical Note Introduction Part 11 in Title 21 of the Code of Federal Regulations includes
More informationCompliance 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 B Provided By: Microtrac,
More information21 CFR Part 11 Module Design
21 CFR Part 11 Module Design email: info@totallab.com web: www.totallab.com TotalLab Ltd Keel House Garth Heads Newcastle upon Tyne NE1 2JE UK Trademarks The following are either registered trademarks
More informationGeneral Disposal Authority 7
General Disposal Authority 7 Facilitative, Transitory, and Short-Term Value Records [DA 576] Introduction This General Disposal Authority (hereafter GDA) has been developed for the use of public offices
More informationExhibitor Software and 21 CFR Part 11
Exhibitor Software and 21 CFR Part 11 Subpart B Electronic Records 15 Columbia Drive Amherst, New Hampshire 03031-2334 No. 11.10 11.10(a) Controls for Closed Systems Validation of systems to ensure accuracy,
More informationAgilent ICP-MS ChemStation Complying with 21 CFR Part 11. Application Note. Overview
Agilent ICP-MS ChemStation Complying with 21 CFR Part 11 Application Note Overview Part 11 in Title 21 of the Code of Federal Regulations includes the US Federal guidelines for storing and protecting electronic
More informationNucleoCounter NC-200, NucleoView NC-200 Software and Code of Federal Regulation 21 Part 11; Electronic Records, Electronic Signatures (21 CFR Part 11)
NucleoCounter NC-200, NucleoView NC-200 Software and Code of Federal Regulation 21 Part 11; Electronic Records, Electronic Signatures (21 CFR Part 11) A ChemoMetec A/S White Paper March 2014 ChemoMetec
More informationThis procedure applies to all Standard Operating Procedures and Protocols that are generated in the NCSBI Crime Laboratory Forensic Biology Section.
NCSBI Forensic Biology Section QA Manual Appendix J Effective Date: December 23, 2004 Title: PROCEDURE FOR COMPLETION OF QUALITY SYSTEM DOCUMENTS Revision 00 1 PURPOSE This procedure details the content
More informationSystem Assessment Report Relating to Electronic Records and Electronic Signatures; 21 CFR Part 11. System: StabNet (Software Version 1.
Page 1 /16 System Assessment Report Relating to Electronic Records and Electronic Signatures; 21 CFR Part 11 System: StabNet (Software Version 1.1) Page 2 /16 1 Procedures and Controls for Closed Systems
More informationDATA BACKUP AND RECOVERY POLICY
DATA BACKUP AND RECOVERY POLICY 4ITP04 Revision 01 TABLE OF CONTENTS 1. REVISION RECORD... 3 2. PURPOSE... 4 3. SCOPE AND APPLICABILITY... 4 4. DEFINITIONS AND ABBREVIATIONS... 4 5. POLICY STATEMENTS...
More informationCell Therapy Data Management
Cell Therapy Data Management Darin Sumstad, CLS (NCA, ASCP) System Administrator, Cell Therapy Clinical Laboratory University of Minnesota Medical Center, Fairview Cell Therapy Data Management Introduction
More informationDonor Credit Card Security Policy
Donor Credit Card Security Policy INTRODUCTION This document explains the Community Foundation of Northeast Alabama s credit card security requirements for donors as required by the Payment Card Industry
More information8/28/2017. What Is a Federal Record? What is Records Management?
Ramona Branch Oliver US Department of Labor What Is a Federal Record? Records include all books, papers, maps, photographs, machine-readable materials, or other documentary materials, regardless of physical
More informationImplementation Support System - ISS USER GUIDE. Network Test and Verification. Version 2.0. Copyright 2006, Quasar, Inc. All Rights Reserve
Implementation Support System - ISS USER GUIDE Version 2.0 Page 4 Table of Contents Table of Contents...5 Revision History... 7 1.0 Introduction... 9 2.0 ISS Basics... 10 2.1 User Personal Computer Set-up
More informationRetention and Disposal of Library Records
MGT-5 Retention and Disposal of Library Records Policy The Warren-Trumbull County Public Library, like other public entities in the State of Ohio, must retain certain records from year to year. Although
More informationScientific Working Group on Digital Evidence
SWGDE Requirements for Report Writing in Digital and Multimedia Forensics Disclaimer: As a condition to the use of this document and the information contained therein, the SWGDE requests notification by
More informationISO/IEC Information technology Security techniques Code of practice for information security controls
INTERNATIONAL STANDARD ISO/IEC 27002 Second edition 2013-10-01 Information technology Security techniques Code of practice for information security controls Technologies de l information Techniques de
More informationIntegration of Agilent UV-Visible ChemStation with OpenLAB ECM
Integration of Agilent UV-Visible ChemStation with OpenLAB ECM Compliance with Introduction in Title 21 of the Code of Federal Regulations includes the US Federal guidelines for storing and protecting
More informationEnterprise Income Verification (EIV) System User Access Authorization Form
Enterprise Income Verification (EIV) System User Access Authorization Form Date of Request: (Please Print or Type) PART I. ACCESS AUTHORIZATION * All required information must be provided in order to be
More informationChromQuest 5.0. Tools to Aid in 21 CFR Part 11 Compliance. Introduction. General Overview. General Considerations
ChromQuest 5.0 Tools to Aid in 21 CFR Part 11 Compliance Introduction Thermo Scientific, Inc. is pleased to offer the ChromQuest chromatography data system (CDS) as a solution for chromatography labs seeking
More informationMMARS Financial, Labor Cost Management (LCM) and Commonwealth Information Warehouse (CIW) Reports
MMARS Policy: Audit Issue Date: April 30, 2007 Date Last Revised: MMARS Financial, Labor Cost Management (LCM) and Commonwealth Information Warehouse (CIW) Reports Executive Summary The Massachusetts Management
More informationCompliance of Shimadzu Total Organic Carbon (TOC) Analyzer with FDA 21 CFR Part 11 Regulations on Electronic Records and Electronic Signatures
NT1D-1275 Compliance of Shimadzu Total Organic Carbon (TOC) Analyzer with FDA 21 CFR Part 11 Regulations on Electronic Records and Electronic Signatures TOC-Control L Ver.1 / LabSolutions DB/CS Ver.6 Part
More informationUNIVERSITY ARCHIVES RECORDS RETENTION SCHEDULE
UNIVERSITY ARCHIVES RECORDS RETENTION SCHEDULE CREATED SEPTEMBER 2015 MICHIGAN STATE UNIVERSITY MSU UNIVERSITY ARCHIVES RECORDS RETENTION SCHEDULE: has developed this retention schedule to document the
More informationISO INTERNATIONAL STANDARD. Information and documentation Records management Part 1: General
Provläsningsexemplar / Preview INTERNATIONAL STANDARD ISO 15489-1 First edition 2001-09-15 Information and documentation Records management Part 1: General Information et documentation «Records management»
More informationLOUGHBOROUGH UNIVERSITY RESEARCH OFFICE STANDARD OPERATING PROCEDURE. Loughborough University (LU) Research Office SOP 1027 LU
LOUGHBOROUGH UNIVERSITY RESEARCH OFFICE STANDARD OPERATING PROCEDURE Loughborough University (LU) Research Office SOP 1027 LU Process for Writing Study Protocols for NHS Research Sponsored by Loughborough
More informationAuditing in an Automated Environment: Appendix E: System Design, Development, and Maintenance
Accountability Modules Auditing in an Automated Environment: Agency Prepared By Initials Date Reviewed By Audit Program - System Design, Development, and Maintenance W/P Ref Page 1 of 1 Procedures Initials
More informationRECORDS AND INFORMATION MANAGEMENT AND RETENTION
RECORDS AND INFORMATION MANAGEMENT AND RETENTION Policy The Health Science Center recognizes the need for orderly management and retrieval of all official records and a documented records retention and
More informationFIRST ARTICLE INSPECTION
FIRST ARTICLE INSPECTION Origination Date: XXXX Document Identifier: Date: Project: Document Status: Document Link: Latest Revision Date Customer, Unique ID, Part Number Draft, Redline, Released, Obsolete
More informationISO TC46/SC11 Archives/records management
ISO TC46/SC11 Archives/records management GUIDANCE FOR IMPLEMENTING DOCUMENTED INFORMATION CLAUSE USING PROCESSES AND CONTROLS OF ISO 30301:2011 Management system for records EXPLANATORY PAPER NOVEMBER
More informationUsage Policy Document Number: OIL-IS-POL-EU
Email Usage Policy Document Number: OIL-IS-POL-EU Document Details Title Email Usage Policy Description Acceptable usage of emails by users Version 1.0 Author Information Security Manager Classification
More informationPolicies & Regulations
Policies & Regulations Email Policy Number Effective Revised Review Responsible Division/Department: Administration and Finance / Office of the CIO/ Information Technology Services (ITS) New Policy Major
More informationProcedure re-written. (i.e. All staff with responsibility for the creation, use and management of organisational responsibility)
Standard Operating Procedure Title of Standard Operation Procedure: Corporate Records Management Procedure Reference Number: ECT002863 Version No: 2.0 Supersedes Versions No: 0.1 Amendments Made: Procedure
More information21 CFR Part 11 LIMS Requirements Electronic signatures and records
21 CFR Part 11 LIMS Requirements Electronic signatures and records Compiled by Perry W. Burton Version 1.0, 16 August 2014 Table of contents 1. Purpose of this document... 1 1.1 Notes to version 1.0...
More informationMySign Electronic Signature
MySign Electronic Signature Advisory Circular Compliance Matrix FAA AC 120 78A Dated 06/22/16 1 Table of Contents Table of Contents 2 Purpose 3 FAA Acceptance 3 Non Requirement for Approval 3 2-2 Electronic
More informationManagement: A Guide For Harvard Administrators
E-mail Management: A Guide For Harvard Administrators E-mail is information transmitted or exchanged between a sender and a recipient by way of a system of connected computers. Although e-mail is considered
More informationWhen the template is complete, the whole Project Initiation 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 Project Initiation Document
More informationMaster Information Security Policy & Procedures [Organization / Project Name]
Master Information Security Policy & Procedures [Organization / Project Name] [Version Number / Date of [Insert description of intended audience or scope of authorized distribution.] Authors: [Names] Information
More informationISO/IEC INTERNATIONAL STANDARD. Systems and software engineering Measurement process. Ingénierie des systèmes et du logiciel Processus de mesure
INTERNATIONAL STANDARD ISO/IEC 15939 Second edition 2007-08-01 Corrected version 2008-10-01 Systems and software engineering Measurement process Ingénierie des systèmes et du logiciel Processus de mesure
More informationRecords Retention Policy
June 21, 2017 Table of Contents 1 Introduction...3 1.1 Purpose...3 1.2 Scope...3 1.3 Review Cycle...3 1.4 Document Owner...3 1.5 Definitions...3 2 Policy...4 2.1 Records and Record Storage...4 2.2 Applicable
More informationTHE TEXAS A&M UNIVERSITY SYSTEM RECORDS RETENTION SCHEDULE
2.1.001 02.100.10 01.404.10 Curriculum Files, including Revisions, Departmental US+5 01.405.10 Instructor/Faculty Evaluations +1 =Academic term 01.406.10 Instructor Grade Books +1 =Academic term 01.407.10
More informationDIRECTIVE ON RECORDS AND INFORMATION MANAGEMENT (RIM) January 12, 2018
DIRECTIVE ON RECORDS AND INFORMATION MANAGEMENT (RIM) January 12, 2018 A. OVERRIDING OBJECTIVE 1.1 This Directive establishes the framework for information management of the Asian Infrastructure Investment
More informationValidation Checklist Appendix A WiZARD2 Secure and 21 CFR 11 Requirements
Appendix A Procedures and Controls for Closed Systems (check = yes) (check = yes) Customers may devise their own validation protocols that may or may not be compliant with 21 CFR 11 Is the system validated?
More informationAn Introduction to Document Control
An BRC Global Standards. Trust in Quality Document Control The control of all documents within food safety and quality systems (for both external and internal use) is important to ensure all your staff
More informationIncident Reporting SOP
1.0 Commercial in Confidence 10-Aug-2006 1 of 6 Incident Reporting SOP Document No: SOP_0106 Prepared by: David Brown Date: 10-Aug-2006 Version: 1.0 1.0 Commercial in Confidence 10-Aug-2006 2 of 6 Document
More information21 CFR Part 11 FAQ (Frequently Asked Questions)
21 CFR Part 11 FAQ (Frequently Asked Questions) and Roles and Responsibilities for Assessment of METTLER TOLEDO STAR e Software Version 16.00, including: - 21 CFR 11 Compliance software option for Compliance
More informationInformation Security Policy
April 2016 Table of Contents PURPOSE AND SCOPE 5 I. CONFIDENTIAL INFORMATION 5 II. SCOPE 6 ORGANIZATION OF INFORMATION SECURITY 6 I. RESPONSIBILITY FOR INFORMATION SECURITY 6 II. COMMUNICATIONS REGARDING
More informationCOMPLETING THE REVISED STUDENT EMPLOYMENT STATUS INFORMATION SHEET
COMPLETING THE REVISED STUDENT EMPLOYMENT STATUS INFORMATION SHEET Departmental Information Step 1 Go to the Student Employment Forms webpage and select Links to Required Paperwork. You can reach it through
More informationAdobe Sign and 21 CFR Part 11
Adobe Sign and 21 CFR Part 11 Today, organizations of all sizes are transforming manual paper-based processes into end-to-end digital experiences speeding signature processes by 500% with legal, trusted
More informationEXCERPT. NIST Special Publication R1. Protecting Controlled Unclassified Information in Nonfederal Systems and Organizations
EXCERPT NIST Special Publication 800-171 R1 Protecting Controlled Unclassified Information in Nonfederal Systems and Organizations An Excerpt Listing All: Security Requirement Families & Controls Security
More informationVersion Control of Study Specific Documents
SOP Title Version Control of Study Specific Documents SOP No. SOP 10 Author Consulted Departments Lead Manager Sign and Print Name Julia Farmery Revision V2.0: Sarah Fahy Lincolnshire Clinical Research
More informationDevelopment of Requirement Specifications for Computer Systems
Standard Operating Procedure Development of Requirement Specifications for Computer Systems This is an example of a Standard Operating Procedure. It is a proposal and starting point only. The type and
More informationValidation Summary SOP
1.0 Commercial in Confidence 03-Aug-2006 1 of 9 Validation Summary SOP Document No: SOP_0700 Prepared by: David Brown Date: 03-Aug-2006 Version: 1.0 1.0 Commercial in Confidence 03-Aug-2006 2 of 9 Document
More informationPolicies & Procedures Effective Date: January 24, Key Control
LSU Health Sciences Center Page 1 of 9 Key Control POLICY: Lost or stolen keys can pose a serious threat to the University s security and the potential theft or loss of State property. In order to provide
More informationISO/IEC INTERNATIONAL STANDARD. Information technology Systems and software engineering FiSMA 1.1 functional size measurement method
INTERNATIONAL STANDARD ISO/IEC 29881 Second edition 2010-08-15 Information technology Systems and software engineering FiSMA 1.1 functional size measurement method Technologies de l'information Ingénierie
More informationMetrohm White paper. FDA 21 CFR Part 11 Requirements for NIR Spectroscopy. Dr. N. Rühl
FDA 21 CFR Part 11 Requirements for NIR Spectroscopy Dr. N. Rühl The prosperity of a society can be evaluated based on many criteria, and the focus is certainly different for each individual. However,
More informationUniversity Network Policies
BACKGROUND Washington State University s network infrastructure and network services are vital to carry out the mission of the University. Policies are needed to ensure the continued integrity of these
More informationLibrary and Archives Canada. Generic Application Guide for the Disposition Authorization for Transitory Records (DA 2016/001)
Library and Archives Canada Generic Application Guide for the Disposition Authorization for Transitory Records (DA 2016/001) Generic Application Guide for the Disposition Authorization for Transitory Records
More informationArchive and Records Management Policy
Archive and Records Management Policy Rationale This Policy is to enable Thomas Carr College to create and maintain accurate and complete records that support and provide evidence of the College s business
More informationWork Instruction Template
Template T2003 Version: H May 8, 2014 DOWNLOADED AND/OR HARD COPY UNCONTROLLED Verify that this is the correct version before use. AUTHORITY DATE Jeffrey Northey (original signature on file) IMS Manager
More informationProject 9H Complaint Form
Content-Based Assessments GO! Fix It Project 9H Complaint Form For Project 9H, you will need the following files: w09h_complaint_form w09h_logo Lastname_Firstname_9H_Complaint_Form From your student files,
More informationWeather and Environmental Services - QMS Manual
1 of 7 1.0 PURPOSE The purpose of this work instruction is to provide detailed guidance to the document formatting and revision conventions used by WES 2 in controlling QMS documents. 2.0 SCOPE This instruction
More informationINTERNATIONAL CIVIL AVIATION ORGANIZATION ASIA and PACIFIC OFFICE ASIA/PAC RECOMMENDED SECURITY CHECKLIST
INTERNATIONAL CIVIL AVIATION ORGANIZATION ASIA and PACIFIC OFFICE Aeronautical Telecommunication Network Implementation Coordination Group (ATNICG) ASIA/PAC RECOMMENDED SECURITY CHECKLIST September 2009
More informationISO/IEC TR Information technology Security techniques Guidelines for the use and management of Trusted Third Party services
This is a preview - click here to buy the full publication TECHNICAL REPORT ISO/IEC TR 14516 First edition 2002-06-15 Information technology Security techniques Guidelines for the use and management of
More informationIDAHO STATE UNIVERSITY POLICIES AND PROCEDURES (ISUPP) ITS Responsible Use of Telephone, Telecommunications, and Networking Resources ISUPP 2280
IDAHO STATE UNIVERSITY POLICIES AND PROCEDURES (ISUPP) ITS Responsible Use of Telephone, Telecommunications, and Networking Resources ISUPP 2280 POLICY INFORMATION Policy Section: Information Technology
More informationCOUNTY OF RIVERSIDE, CALIFORNIA BOARD OF SUPERVISORS POLICY. ELECTRONIC MEDIA AND USE POLICY A-50 1 of 9
ELECTRONIC MEDIA AND USE POLICY A-50 1 of 9 Purpose: The purpose of this policy is to establish guidelines for proper use of all forms of electronic media. As used in this policy, electronic media includes,
More informationPOLICY TITLE: Record Retention and Destruction POLICY NO: 277 PAGE 1 of 6
POLICY TITLE: Record Retention and Destruction POLICY NO: 277 PAGE 1 of 6 North Gem School District No. 149 establishes the following guidelines to provide administrative direction pertaining to the retention
More informationOffice of Human Resources 3/28/13 Page 1 of 7
JOB FAMILY CONCEPT This job family consists of eight levels of Information Systems Technical work distinguished by the complexity of the responsibilities assigned and characterized by the type of equipment,
More informationPolicy Summary: This guidance outlines ACAOM s policy and procedures for managing documents. Table of Contents
Policy Title: Approved By: ACAOM Commissioners History: Policy Implementation Date: 28 October 2016 Last Updated: Related Policies: ACAOM -Records Retention Schedule References: Responsible Official: ACAOM
More informationUsing "TiNet 2.5 Compliant SR1" software to comply with 21 CFR Part 11
2003-08-08/dö Using "TiNet 2.5 Compliant SR1" software to comply with 21 CFR Part 11 The Title 21 Code of Federal Regulations Electronic Records; Electronic Signatures of the U.S. Food and Drug Administration,
More informationRequirements for the Certification of a Welding Quality Control Co-ordinator
CERTIFICATION SCHEME FOR PERSONNEL DOCUMENT No. CSWIP- QCC-20-08 Requirements for the Certification of a Welding Quality Control Co-ordinator 2 nd Edition January 2011 Issued under the authority of the
More informationBERGRIVIER MUNICIPALITY
BERGRIVIER MUNICIPALITY PATCH MANAGEMENT POLICY APRIL 2012 C:\Users\HJanuarie\Desktop\New folder (6)\INFORMATION TECHNOLOGY\Patch Management Policy.docx/cmd 1 CONTENTS Version Control.. Document History.
More information2016 SC REGIONAL HOUSING AUTHORITY NO. 3 S EIV SECURITY POLICY
2016 SC REGIONAL HOUSING AUTHORITY NO. 3 S EIV SECURITY POLICY Purpose: The purpose of this policy is to provide instruction and information to staff, auditors, consultants, contractors and tenants on
More informationTARGET2-SECURITIES INFORMATION SECURITY REQUIREMENTS
Target2-Securities Project Team TARGET2-SECURITIES INFORMATION SECURITY REQUIREMENTS Reference: T2S-07-0270 Date: 09 October 2007 Version: 0.1 Status: Draft Target2-Securities - User s TABLE OF CONTENTS
More informationISO INTERNATIONAL STANDARD. Non-destructive testing of welds Ultrasonic testing Acceptance levels
INTERNATIONAL STANDARD ISO 11666 First edition 2010-12-15 Non-destructive testing of welds Ultrasonic testing Acceptance levels Contrôle non destructif des assemblages soudés Contrôle par ultrasons Niveaux
More informationRPR CRITERIA AND FORMATS
RPR CRITERIA AND FORMATS PURPOSE This procedure establishes design criteria and standard formats for detailed procedures and records required for effective operations, communications and management of
More informationPHILADELPHIA POLICE DEPARTMENT DIRECTIVE 12.1
PHILADELPHIA POLICE DEPARTMENT DIRECTIVE 12.1 Issued Date: 06-11-99 Effective Date: 06-11-99 Updated Date: SUBJECT: OFFICIAL FORMAT FOR WRITTEN COMMUNICATION 1. POLICY A. The following guidelines have
More informationPOLICIES AND PROCEDURES
Integrated Information Technology Services POLICIES AND PROCEDURES Utica College Email POLICY: Email is Utica College s sole accepted mechanism for official electronic communication in the normal conduct
More informationAnnex 1 to NIST Special Publication Recommended Security Controls for Federal Information Systems
Annex 1 to NIST Special Publication 800-53 Recommended Security Controls for Federal Information Systems Minimum Security Controls Low Baseline AC-1 ACCESS CONTROL POLICY AND PROCEDURES The organization
More information