| Titre : | Document Control and Records Management |
| Auteurs : | Tremblay Julian, Auteur |
| Support: | Livre |
| Editeur : | Bibliotex |
| ISBN/ISSN/EAN : | 978-1-80620-459-5 |
| Format : | cd |
| Note générale : | Julian Tremblay is a records‑management specialist with expertise in document control systems for regulated industries. He holds a Master’s in Information Governance and has designed electronic‑document‑management frameworks for pharmaceutical and aerospace clients. Julian publishes on metadata standards, retention‑policy development, and secure archival practices. He leads certification courses on audit‑trail implementation and compliance with 21 CFR Part 11. His current work explores blockchain‑backed registries for tamper‑evident document control |
| Langues: | Français |
| Mots-clés: | Management ; Control ; Records |
| Résumé : |
• Describes systems for classifying, versioning, and distributing controlled documents to ensure accuracy and traceability.
• Covers retention schedules, archival methods, and disposal protocols aligned with legal and industry requirements. • Highlights digital solutions—EDMS, access controls, audit trails—to streamline document workflows and governance. |
| Sommaire : |
Chapter 1 Fundamentals of Document Control 1
Introduction..........................................................................................................3 1.1 Definition and Scope of Document Control...............................................6 1.1.1 Meaning and Objectives.................................................................. 7 1.1.2 Key Terminology.............................................................................. 8 1.1.3 Importance in Organizational Context......................................... 9 1.2 Components of an Effective Document Control System........................10 1.2.1 Document Identification and Classification............................... 11 1.2.2 Control of Versions and Revisions.............................................. 13 1.2.3 Retention and Disposition Control............................................. 14 1.3 Roles and Responsibilities in Document Control...................................15 1.3.1 Document Controller Duties........................................................ 16 1.3.2 Departmental Responsibilities..................................................... 18 1.3.3 Management Oversight................................................................ 19 1.4 Standardization and Documentation Hierarchy.....................................20 1.4.1 Policy and Procedure Documentation........................................ 21 1.4.2 Work Instructions and Templates............................................... 23 1.4.3 Records and Supporting Documents.......................................... 24 1.5 Document Lifecycle Phases........................................................................25 1.5.1 Creation and Approval................................................................. 27 1.5.2 Distribution and Usage................................................................. 28 1.5.3 Archiving and Disposal................................................................ 29 1.6 Compliance and Quality Alignment.........................................................30 1.6.1 Regulatory Requirements............................................................. 31 Chapter 2 Records Management Principles and Practices 45 Introduction .......................................................................................................47 2.1 Record Classification and Indexing Systems...........................................48 2.1.1 Taxonomy of Records.................................................................... 49 2.1.2 Indexing Standards........................................................................ 51 2.1.3 Metadata Elements........................................................................ 52 2.2 Records Retention and Disposition Schedules........................................53 2.2.1 Establishing Retention Periods.................................................... 54 2.2.2 Legal Retention Obligations......................................................... 56 2.2.3 Secure Disposal Methods.............................................................. 57 2.3 Access Control and Security Measures.....................................................59 2.3.1 Authorization Protocols................................................................ 60 2.3.2 Confidentiality Levels................................................................... 61 2.3.3 Access Logs and Monitoring........................................................ 62 2.4 Records Storage and Maintenance............................................................63 2.4.1 Physical Storage Requirements.................................................... 64 2.4.2 Electronic Storage Systems........................................................... 65 2.4.3 Backup and Redundancy.............................................................. 67 2.5 Records Management Policy Development.............................................68 2.5.1 Policy Objectives............................................................................ 69 2.5.2 Implementation Framework........................................................ 70 2.5.3 Review and Updating Procedures.............................................. 71 2.6 Challenges in Records Management.........................................................72 2.6.1 Technological Advancements....................................................... 73 2.6.2 Compliance with Regulations...................................................... 74 2.6.3 Resource Allocation....................................................................... 76 Multiple Choice Questions...............................................................................82 References...........................................................................................................83 Chapter 4 Document Creation, Review, and Approval Processes 131 Introduction......................................................................................................133 4.1 Document Creation Standards.................................................................134 4.1.1 Formatting Guidelines................................................................ 135 4.1.2 Template Utilization.................................................................... 136 4.1.3 Content Validation Rules............................................................ 137 4.2 Review and Verification Processes..........................................................139 4.2.1 Review Committee Roles............................................................ 140 4.2.2 Feedback and Revision Cycles................................................... 141 4.2.3 Approval Documentation........................................................... 142 4.3 Approval and Authorization Protocols...................................................144 4.3.1 Authority Hierarchies.................................................................. 145 4.3.2 Digital Signatures and Authentication..................................... 146 4.3.3 Controlled Release Mechanisms................................................ 148 4.4 Document Distribution and Accessibility..............................................150 4.4.1 Controlled Copies........................................................................ 151 4.4.2 Distribution Lists......................................................................... 152 4.4.3 User Access Controls................................................................... 153 4.5 Change Control and Document Updates...............................................154 4.5.1 Change Request Procedures....................................................... 155 4.5.2 Impact Assessments.................................................................... 156 4.5.3 Reissue and Notification............................................................. 157 4.6 Audit Trails and Review Records............................................................158 4.6.1 Documentation of Changes........................................................ 159 4.6.2 Version History Reports.............................................................. 160 4.6.3 Compliance Verification.............................................................. 161 Multiple Choice Questions.............................................................................167 References.........................................................................................................168 Chapter 5 Compliance, Auditing, and Risk Management 175 Introduction......................................................................................................177 5.1 Regulatory Frameworks and Standards.................................................182 5.1.1 ISO 9001 and Document Control............................................... 184 5.1.2 GDPR and Data Management.................................................... 185 5.1.3 Industry-Specific Compliance.................................................... 186 5.2 Internal and External Auditing Practices...............................................188 5.2.1 Audit Preparation and Planning................................................ 189 5.2.2 Evidence Collection..................................................................... 190 5.2.3 Corrective and Preventive Actions............................................ 191 5.3 Risk Identification in Document Control...............................................192 5.3.1 Operational Risks......................................................................... 193 5.3.2 Information Security Risks......................................................... 194 5.3.3 Non-Compliance Risks............................................................... 195 5.4 Mitigation Strategies and Controls.........................................................196 5.4.1 Preventive Measures................................................................... 198 5.4.2 Contingency Planning................................................................. 199 5.4.3 Continuous Risk Monitoring..................................................... 200 5.5 Non-Conformance and Incident Reporting...........................................201 5.5.1 Incident Documentation............................................................. 202 5.5.2 Root Cause Analysis.................................................................... 203 5.5.3 Corrective Action Implementation............................................ 204 5.6 Management Review and Reporting......................................................205 5.6.1 Performance Metrics.................................................................... 206 5.6.2 Audit Reporting Templates........................................................ 207 5.6.3 Management Review Meetings................................................. 208 Multiple Choice Questions.............................................................................214 References.........................................................................................................215 Chapter 6 Digital Records and Information Governance 219 Introduction......................................................................................................221 6.1 Information Governance Frameworks...................................................226 6.1.1 Governance Structures................................................................ 228 6.1.2 Policy Integration......................................................................... 229 6.1.3 Accountability Systems............................................................... 231 6.2 Electronic Records Management (ERM).................................................232 6.2.1 System Requirements.................................................................. 233 6.2.2 Metadata Standards..................................................................... 234 6.2.3 Long-Term Accessibility............................................................. 235 6.3 Data Protection and Privacy.....................................................................237 6.3.1 Personal Data Classification....................................................... 238 6.3.2 Data Minimization Principles.................................................... 239 6.3.3 Breach Response Procedures...................................................... 240 6.4 Cloud-Based Document Control Systems..............................................241 6.4.1 Cloud Storage Models................................................................. 242 6.4.2 Data Migration Strategies........................................................... 243 6.4.3 Vendor Security Evaluations...................................................... 244 6.5 Electronic Signatures and Authentication..............................................245 6.5.1 Legal Recognition........................................................................ 246 6.5.2 Validation Technologies.............................................................. 247 6.5.3 Auditability of e-Signatures........................................................ 248 6.6 Integration of Document Control with IT Systems...............................250 6.6.1 ERP and QMS Integration.......................................................... 251 6.6.2 Interoperability Standards.......................................................... 252 6.6.3 Automation Opportunities......................................................... 253 Multiple Choice Questions.............................................................................259 References.........................................................................................................260 Chapter 7 Training, Communication, and Change Management 267 Introduction......................................................................................................269 7.1 Importance of Training in Document Control.......................................272 7.1.1 Knowledge Requirements.......................................................... 273 7.1.2 Training Delivery Methods........................................................ 275 7.1.3 Competency Assessment............................................................ 276 7.2 Communication Strategies.......................................................................277 7.2.1 Information Dissemination........................................................ 278 7.2.2 Stakeholder Engagement............................................................ 280 7.2.3 Feedback Channels...................................................................... 281 7.3 Change Management Processes..............................................................282 7.3.1 Managing Document Updates................................................... 283 7.3.2 User Adaptation Strategies......................................................... 284 7.3.3 Change Communication Plans.................................................. 286 7.5 Performance Evaluation and Continuous Learning.............................287 7.5.1 KPI Development......................................................................... 289 7.5.2 Evaluation Tools.......................................................................... 290 7.5.3 Continuous Improvement Culture............................................ 291 7.6 Documentation of Training Records.......................................................292 7.6.1 Attendance and Completion Logs............................................. 293 7.6.2 Competency Certification........................................................... 294 7.6.3 Audit of Training Effectiveness.................................................. 295 7.7 Challenges in Training and Communication........................................297 7.7.1 Resistance to Change................................................................... 298 7.7.2 Miscommunication Issues.......................................................... 299 7.7.3 Resource Limitations................................................................... 300 Multiple Choice Questions.............................................................................306 References.........................................................................................................307 Chapter 8 Best Practices in Document and Records Management 315 Introduction......................................................................................................317 8.1 Establishing a Controlled Environment.................................................317 8.1.1 Document Numbering Systems................................................. 318 8.1.2 Controlled Distribution Lists..................................................... 319 8.1.3 Periodic Review Mechanisms.................................................... 320 8.2 Quality and Efficiency Optimization......................................................322 8.2.1 Document Process Mapping...................................................... 323 8.2.2 Error Reduction Techniques....................................................... 325 8.2.3 Efficiency Monitoring Tools....................................................... 326 8.3 Security and Confidentiality Practices....................................................328 8.3.1 Access Control Policies............................................................... 329 8.3.2 Encryption and Backup Procedures.......................................... 330 8.3.3 Incident Response Plans............................................................. 331 8.4 Documentation in Quality Management Systems................................332 8.4.1 Standard Operating Procedures (SOPs)................................... 334 8.4.2 Corrective and Preventive Action Records.............................. 335 8.4.3 Quality Manual Control.............................................................. 336 8.5 Document Review and Continuous Improvement...............................337 8.5.1 Periodic Review Scheduling....................................................... 338 8.5.2 Review Committee Roles............................................................ 339 8.5.3 Feedback Implementation.......................................................... 340 8.6 Metrics and Performance Reporting.......................................................341 8.6.1 Key Performance Indicators....................................................... 343 8.6.2 Reporting Dashboards................................................................ 344 8.6.3 Benchmarking and Evaluation................................................... 345 8.7 Training and Development for Staff.......................................................346 8.7.1 Training Programs on Document Management..................... 347 8.7.2 Continuous Professional Development.................................... 348 8.7.3 Role of Leadership in Training.................................................. 349 Multiple Choice Questions.............................................................................355 References.........................................................................................................356 |
| En ligne : | https://www.bibliotex.com/explore;searchText=9781806204595;mainSearch=1;themeName=Default-Theme/product-details/716653 |
Exemplaires
| Cote | Support | Localisation | Disponibilité |
|---|---|---|---|
| aucun exemplaire | |||
Consulter en ligne (1)
 https://documentation.univ-biskra.dz/digital_docs/9781806204595.pdf URL |
