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Cosa dicono le GAMP sulla Security (nelle appendici operative O3-O13)

(in lingua inglese)

- The actual production process
- Sensing the production process, manipulating the production process
- Monitoring, supervisory control and automated control of the production process
- Work flow / recipe control to produce the desired end products. Maintaining records and optimizing the production process
- Establishing the basic plant schedule - production, material use, delivery, and shipping. Determining inventory levels

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Atti di convegni o presentazioni contenenti case history
SAVE ottobre 2015 Data Integrity e Security nei sistemi per la produzione di farmaci

Pubblicato
da Alessia De Giosa
SAVE 2015Segui aziendaSegui




Estratto del testo
Veronafiere 27-28 ottobre 2015 Gli atti dei convegni e più di 6.000 contenuti su www.verticale.net Cogenerazione Termotecnica Industriale Pompe di Calore 27 ottobre Cogenerazione Termotecnica Industriale Pompe di Calore Alimentare Alimentare Petrolchimico Alimentare 28 ottobre Alimentare Petrolchimico Alimentare Alimentare Petrolchimico Visione e Tracciabilità 28 ottobre Luce Energia Domotica LED Luce Energia Domotica LED Dott. Enzo Maria Tieghi www.servitecno.it GAMP5 e la Security
(Protezione di reti e sistemi da rischi informatici)
' Good Practice Guides ' Appendici 03-O13 Enzo M. Tieghi - etieghi@servitecno.it ISPE Italy Affiliate
GAMP Forum Italia
Dove sono i sistemi da proteggere' 2 www.servitecno.it Ovunque: Industrial, Processes,
Buildings, Manufacturing &
Infrastructures Definiamo il ''perimetro'' 3 www.servitecno.it IT Security & Control System Protection: dove' Level 4 Level 1 Level 2 Level 3 Business Planning & Logistics Plant Production Scheduling, Operational Management, etc Manufacturing Operations Management Dispatching Production, Detailed Production Scheduling, Reliability Assurance, ... Batch Control Discrete Control Continuous Control 1 - Sensing the production process, manipulating the production process 2 - Monitoring, supervisory control and automated control of the production process 3 - Work flow / recipe control to produce the desired end products. Maintaining records
and optimizing the production process. Time Frame Days, Shifts, hours, minutes, seconds 4 - Establishing the basic plant schedule - production, material use, delivery, and
shipping. Determining inventory levels. Time Frame Months, weeks, days Level 0 0 - The actual production process Level 4 Level 1 Level 2 Level 3 Business Planning & Logistics Plant Production Scheduling, Operational Management, etc Manufacturing Operations Management Dispatching Production, Detailed Production Scheduling, Reliability Assurance, ... Batch Control Discrete Control Continuous Control 1 - Sensing the production process, manipulating the production process 2 - Monitoring, supervisory control and automated control of the production proces 3 - Work flow / recipe control to produce the desired end products. Maintaining records
and optimizing the production process. Time Frame Days, Shifts, hours, minutes, seconds 4 - Establishing the basic plant schedule - production, material use, delivery, and
shipping. Determining inventory levels. Time Frame Months, weeks, days Level 0 0 - The actual production process ANSI/ISA95 Functional Hierarchy 4 www.servitecno.it 5 www.servitecno.it ISO27000 vs ISA99 vs 61508-511 : Security vs Safety GAMP® 5: A Risk-Based Approach to
Compliant GxP Computerized Systems
6 GAMP® Good Practice Guides 7 ' GAMP® Good Practice Guide: A Risk-Based Approach to Calibration Management (Second Edition) ' GAMP® Good Practice Guide: A Risk-Based Approach to Electronic Records and Signatures ' GAMP®Good Practice Guide: A Risk-Based Approach to GxP Compliant Laboratory Computerized
Systems (Second Edition) ' GAMP® Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems (Second
Edition) ' GAMP® Good Practice Guide: A Risk-Based Approach to Operation of GxP Computerized Systems -
A Companion Volume to GAMP 5 ' GAMP® Good Practice Guide: A Risk-Based Approach to Regulated Mobile Applications ' GAMP® Good Practice Guide: A Risk-Based Approach to Testing of GxP Systems (Second Edition) ' GAMP® Good Practice Guide: Electronic Data Archiving ' GAMP® Good Practice Guide: Global Information Systems Control and Compliance ' GAMP® Good Practice Guide: IT Infrastructure Control and Compliance ' GAMP® Good Practice Guide: Legacy Systems ' GAMP® Good Practice Guide: Manufacturing Execution Systems '' A Strategic and Program
Management Approach GAMP® 5: Table of Appendices 8 GAMP® 5: Appendix O11
''Security Management'
9 GAMP® 5: Appendix O10
''Business Continuity Management'
10 GAMP® 5: Appendix O9
''Backup and Restore'
11 GAMP® 5: Appendix O3
''Performance Monitoring'
12 GAMP® 5: Appendix O4
''Incident Management'
13 GAMP® 5: Appendix O5
''Corrective and Preventive Action'
14 GAMP® 5: Appendix O6 ''Operational
Change and Configuration Management'
15 GAMP® 5: Appendix O7
''Repair Activity'
16 GAMP® 5: Appendix O8
''Periodic Review'
17 GAMP® 5: Appendix O13
''Archiving and Retrieval'
18 Zones & Conduits (ISA99/IEC62443) Esempio di ''Security Architecture' nei sistemi di automazione e controllo Enterprise Control Network Manufacturing Operations Network Perimeter Control Network Control System Network Process Control Network Source: Byres Security Network/System Segmentation 21 www.servitecno.it ' Limit the ingress and egress points
through zone boundaries ' Protect the connections between
zones ' Zones & conduits are logical ' For practical purposes, match zones
to network architecture as much as
possible 22 www.servitecno.it Network/System Segmentation Esempio di rete stabilimento (produzione batch) Per maggiori informazioni' 24 www.servitecno.it 24 25 Domande' Dubbi' Enzo M. Tieghi: etieghi@servitecno.it www.servitecno.it


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