IT & Automation. Service process hos. Novo Nordisk A/S. COWIs temadag. Date: 6 of november 2008 Prepared by JKSQ/APKJ

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Jesse Patterson
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1 COWIs temadag IT & Automation Service process hos Novo Nordisk A/S Date: 6 of november 2008 Prepared by JKSQ/APKJ 1

2 The scope Service process 2

3 The idea One global framework IT & Automation service is a common task for all areas and therefore a candidate for one common Global framework A more harmonized way of working with operation, maintenance and service Deploy a system to automate the trivial data collection tasks and then use the information to optimize the service process Avoid that each site develop their own systems for this common process 3

and service Deploy a system to automate the trivial data collection tasks and then use the information

4 Benefit Quality-Deliver-Cost Compliance Considerable reduction in paper for archiving and elimination of risk of rework and delays caused by trivial GMP errors (Right first time) Clear Roles and responsibilities, and audit trail to track changes Agility Reduced the change management process time Standardization of Configuration Management IT platform and Data model Best practice IT&A employees have to follow standard workflow and hereby eliminate errors Harmonization of the level of Configuration Management reporting Data available for consolidated PSIT reports no need for tedious Excel sheets Optimization Decrease time spent on trivial reviewing and registration task Remove the demand for external consultants currently doing this job Forced lean of CI s to reduce the registration scope to the necessary level Decrease the time for system restore 4

employees have to follow standard workflow and hereby eliminate errors Harmonization of the level of Configuration Management reporting Data available for consolidated PSIT reports no need for

5 Process Different playfields Equipment IT (ITIL) IT & Automation (GAMP5 & ITIL) Product Performance Information control Process control Operation Many events Few users/function Few roles/process Transactions Many users/function Many roles/process Real-time event data Few users/function Few roles/process Maintenance Corrective Preventive Overhaul Incidents Problems Release Repair/restore Problem solving Change mgt. Process Production Utilities Transaction Relation Data Process data Parameter Delivery Availability Reliability Predictability Maintainability Efficiency Availability Accountability Completeness Usability Effectiveness Availability Reliability Predictability Practicability Efficiency 5

Preventive Overhaul Incidents Problems Release Repair/restore Problem solving Change mgt.

6 Process Service process as is 6

7 Process Service process to be To Be CM User User Admin => NNIT? Asset management QA dok Validation Global CMDB Chacon; QBIQ Local Server/ PC HMI Maintenance Note: A full automatic configuration review save on average about 2 month of manually work per location 7

Server/ PC HMI Maintenance Note: A full automatic configuration

8 Process Function domains Change mgmt. Deviation control Corrective action Change request Release mgmt. Validation Configuration mgmt. Equipment control Software control Document control Training control Configuration review Service Cockpit Surveilance Diagnostic Incident mgmt. Problems mgmt. Operation mgmt. Service mgmt. KPI monitoring Risk assessment System strategies Resource planning Project portfolio mgmt. 8

Equipment control Software control Document control Training control Configuration review Service

9 Process IT & Automation service Request Request 9

10 Function GAMP 5 10

11 Function Monthly KPI Release Planning Measures ability to implement agreed and prioritised changes in the system Time to resolved Incidents and Service Requests Measures ability to solve incidents or service requests within agreed targets Closure rates Measures ability to solve an agreed percentage of incidents and service requests System Availability Measures ability to keep a system available for its users as agreed System Response time Measures ability to keep a system responding to its user as agreed First Time Resolution Measures the ability of Global Service Desk to resolve incoming helpdesk cases Finance Measures ability to keep financial budget on the system 11

System Availability Measures ability to keep a system available for its users as agreed System Response time Measures ability to keep a system responding to its user as

12 Function KPI Thresholds Release planning and management Percentage of planned and prioritised change requests implemented in the relevant month <90% 90-95% >95% Time to Resolved 75% of incidents and service request must have a work-around or a permanent solution within agreed time <75% N/A >75% Closure rate Percentage of new incidents and service request closed within in the relevant month <80% 80-90% >90% System availability Percentage of system availability within the last quarter compared to 3-month average baseline <95% 95-99,5% >99,5% System response time Average response time for system transactions within the last quarter compared to 3-month average baseline <75% 75-90% >90% First Time Resolution Percentage of incoming helpdesk cases resolved by Global Service Desk Gold: <75% Silver: <55% Gold: 75% - 80% Silver: 55% - 60% Gold: >80% Silver: >60% Bronze: <25% Bronze: 25% - 30% Bronze: >30% Finance Actual costs must not exceed planned values by more than 5% >10% 5% - 10% <5% 12

within in the relevant month <80% 80-90% >90% System availability Percentage of system availability within the last quarter compared to 3-month average baseline <95% 95-99,5% >99,5% System response

13 People Function Impact Change mgt Config mgt Service Cockpit Service mgt Users Technicians Quality Assurance Sub matter Expert System manager Process owner Executive 13

14 People Roles and Responsibilities IT organisation Executive Responsibilities Endorse the System Strategy Owns and approved the IT politics System advisory board Owns and approved the System Strategy Govern the Change Portfolio Change advisory board System manager Sub matter expert Audit and Review process Change management Service management and Performance Monitoring Business Contingency management Corrective and preventive actions Advise and guide about sub matters System pilot Incidents Management Security and System administration Super User Incidents registration Advise and guide about the process 14

process Change management Service management and Performance Monitoring Business Contingency management Corrective and preventive actions Advise and

15 People Organization SAB Process owner System manager Function area x, y, z Process x, y, z Process x Super User Technician x User x Process y Super User Technician y User y CAB System manager SME x SME y SME z Super User x Super User y Super User z Process z Function x Function y SME Expert y Pilot y Function z SME Expert z Pilot z Super User Technician z User z SME Expert x Pilot x 15

manager SME x SME y SME z Super User x Super User y Super User z Process z Function x Function y

16 System Function Configuration management Automated Configuration Review Surveillance Service cockpit Global Benchmarking 16

17 System Alternative Solutions Month Overview Days Paper CIL CMDB Automatic Config. Review Service Server Configuration Control Configuration Management? Automated Configuration Review? Surveillance? Service Cockpit? Global Benchmarking? 17

Review Service Server Configuration Control Configuration

18 System Service server 18

19 Solution Requirements Vendor Familiar with change management in a GMP regulated environment Experience with validation and pharmacy standards Solution Proven technology Off shelf system Part 11 compliance Interface to both process and IT equipment Prepared for the whole MIT Service packet Global Easy Access Web solution Local time zones and languages 19

Off shelf system Part 11 compliance Interface to both process and IT equipment Prepared

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