Building a highly-integrated management system in Fusion Lifecycle

Transcription

1 Building a highly-integrated management ytem in Fuion Lifecycle Neil Barker Quality Manager Advanced Oncotherapy plc Join the converation #AU2017 #AULondon

2 INTEGRATION

3 Integrated Management Sytem An Integrated Management Sytem (IMS) integrate all of an organization' ytem and procee in to one complete framework, enabling an organization to work a a ingle unit with unified objective.

4 Company overview

5

6 Overview of Advanced Oncotherapy plc Advanced Oncotherapy i developing a 24m long, 230MeV, proton therapy ytem for the treatment of radio-enitive tumour Lited on AIM HQ in London with operation in UK, Switzerland and the US >90 employee, including 60 baed in Geneva A ditinctive collaboration with CERN Operate the larget particle phyic laboratory in the world Created the world mot powerful accelerator (LHC)... following the acquiition of ADAM in 2013 A CERN pin off Deigned and built the firt linear proton accelerator Technology validated at 72 MeV LHC (Large Hadron Collider) 27 km 14,000,000 MeV % peed of light LIGHT (LINAC for Image Guided Hadron Therapy) 24 metre 230 MeV 60% peed of light

7 Proton Therapy a More Effective Type of Radiation Therapy Energy releaed by proton detroy cancer cell in the ame way a x-ray Validated technology Firt clinical ue in 1954 More than 130,000 patient treated to date Le healthy tiue damaged during treatment Bragg-peak effect

8 Proton Therapy Illutration and Key Benefit The beauty i that you can ue higher doe of radiation and therefore increae cure rate, while avoiding tiue that are exquiitely enitive to radiotherapy and therefore at high rik of ide effect. (Dr Adrian Crellin, Dean, Faculty of Oncology, Royal College of Radiologit)) Non-invaive Better targeting to the tumour and not urrounding organ Reduced ide effect and better quality of life Can reduce length of treatment and thu cot Particularly beneficial When tumour are located near critical organ or tructure (e.g. brain, heart or pinal cord) For children with cancer Pier 9 Teenage girl treated for medulloblatoma Proton X-ray Retrictive Lung Dieae 0% 60% Growth Abnormality 20% 100% IQ Drop of 10pt at 6yr 2% 29%

9 Product overview

10 Overview of the LIGHT Sytem Technology already validated Firt linear accelerator for proton therapy Same frequency a conventional radiotherapy linac

11 Proton Injection Sytem RF Quadrupole SCDTL (x4) Side-Coupled Drift Tube Linac CCL (x15) Coupled Cavity Linac Beam Tranfer Line Nozzle Sytem Treatment Room

12 An example of one accelerator element Preciion-machined oxygen-free high-purity copper plate Each et of plate i different Over 1000 copper component in the accelerating tructure

13 IT Sytem Architecture and Product Lifecycle

14 How our IT ytem integrate

15 Product Lifecycle Ditinct lifecycle phae with defined cope Gate review to pa from one phae to the next Review record are captured in PLM and linked to Item/Product Deliverable for each review can be defined Future development will conider embedding review in workflow

16 How thi look in Fuion Lifecycle

17 Buine procee and buine object

18 Traceability

19 Buine procee managed in Fuion Lifecycle Product management Document management Change and Configuration management Audit management Equipment management Calibration and Maintenance Cutomer management Supplier management Problem and incident management CAPA Deviation Non-conformity Complaint Return Vigilance Regulatory inform Intellectual Property management Each of thee procee involve one or more buine object. Each cla of buine object repreent a workpace in Fuion Lifecycle

20 The Fuion Lifecycle Workpace Item & BoM Document Material Equipmen t People Licence In/Out ICR/ICO DCR/DCO Supplier Calibratio n Invention dicloure Trade Mark Audit Cutomer Maintenanc e Patent Deign Right/ dicloure Nonconformitie Complaint Vigilance Iue Deviation Tak Legacy Item & BOM Legacy ECR/ECO Databae Right/ dicloure Return Material CAPA Regulatory Inform Legacy ECR repone

21 Let look at ome buine procee. Supplier Audit Incoming inpection Cutomer complaint Change control Intellectual Property management

22 Supplier Audit Regulatory Inform Deviation CAPA Tak Iue Supplier Cutomer Calibratio n Maintenanc e Equipmen t Invention dicloure People Patent Trade Mark Licence In/Out Deign Right/ dicloure Databae Right/ dicloure Nonconformitie Complaint Vigilance Audit Return Material Item & BoM Document DCR/DCO ICR/ICO Material Legacy Item & BOM Legacy ECR/ECO Legacy ECR repone

23 Incoming Inpection Regulatory Inform Deviation CAPA Tak Iue Supplier Cutomer Calibratio n Maintenanc e Equipmen t Invention dicloure People Patent Trade Mark Licence In/Out Deign Right/ dicloure Databae Right/ dicloure Nonconformitie Complaint Vigilance Audit Return Material Item & BoM Document DCR/DCO ICR/ICO Material Legacy Item & BOM Legacy ECR/ECO Legacy ECR repone

24 Cutomer Complaint Regulatory Inform Deviation CAPA Tak Iue Supplier Cutomer Calibratio n Maintenanc e Equipmen t Invention dicloure People Patent Trade Mark Licence In/Out Deign Right/ dicloure Databae Right/ dicloure Nonconformitie Complaint Vigilance Audit Return Material Item & BoM Document DCR/DCO ICR/ICO Material Legacy Item & BOM Legacy ECR/ECO Legacy ECR repone

25 Change Control Regulatory Inform Deviation CAPA Tak Iue Supplier Cutomer Calibratio n Maintenanc e Equipmen t Invention dicloure People Patent Trade Mark Licence In/Out Deign Right/ dicloure Databae Right/ dicloure Nonconformitie Complaint Vigilance Audit Return Material Item & BoM Document DCR/DCO ICR/ICO Material Legacy Item & BOM Legacy ECR/ECO Legacy ECR repone

26 Intellectual Property Management Regulatory Inform Deviation CAPA Tak Iue Supplier Cutomer Calibratio n Maintenanc e Equipmen t Invention dicloure People Patent Trade Mark Licence In/Out Deign Right/ dicloure Databae Right/ dicloure Nonconformitie Complaint Vigilance Audit Return Material Item & BoM Document DCR/DCO ICR/ICO Material Legacy Item & BOM Legacy ECR/ECO Legacy ECR repone

27 What next. Work toward complete integration of PDM, PLM and ERP activitie to minimie adminitration and reduce the rik of error Create a highly integrated management ytem with embedded workflow to force adherence to proce and thu reduce rik. Have all mater data and related object in one place for eae of audit. Make PLM our one-top hop for evidence of buine procee and reporting. Seek further opportunitie for integration with other platform uch a HR management, requirement management and tet management.

28 Our flaghip intallation Harley Street

29 Acknowledgement Viualiation created uing Thank to P-Cure Ltd. for the viualiation of patient poitioning, imaging and treatment

30 Thank you from

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