Improved Time to Results in Life Sciences PharmaSuite

Transcription

1 Improved Time to Results in Life Sciences PharmaSuite Mark Drochek Information Solutions Technical Consultant November 5, 2012

2 Business Pressures in Life Sciences Maximize productivity Minimize production costs Reduce scrap Increase performance Reduce inventories Ensure regulatory compliance Improve quality Reduce errors and inaccuracies Use assets more efficiently Reduce quality review time Reduce cycle time Reduce paper Enable improvement initiatives 2

3 PharmaSuite The Rockwell Automation MES Strategy PharmaSuite Product Strategy PharmaSuite Modules Connectivity Questions 3

4 The Rockwell Automation MES Strategy Bring to market high-value, vertical industry solutions based on a single MES platform Leverage the synergies of our industry leading MES solutions and expertise with Rockwell Automation process automation and global delivery capabilities Continue the tradition of small company innovation and customer focus 4

5 Multi-Industry MES Strategy 5

6 PharmaSuite Modules 6

7 PharmaSuite - Product Strategy PharmaSuite is based on three major pillars: Industry knowledge Pharma MES experience Passion for innovation Life Science Industry is compelled by the general MES values: Lowered cost of compliance Increased production efficiency Lowering inventory PharmaSuite provides additional value enablers aligned with A holistic vision of MES Increasing speed and efficiency for any involved role 7

8 PharmaSuite Innovation for the Recipe Life Cycle Process Design Recipe Design Analysis Time to results for every user Review & Approval Planning & Dispatching Recipe Execution Building Block SDK 8

9 PharmaSuite Dispense Workflow-based user interface guides operator through complex weighing processes Complete and correct protocol of all weighing activities GxP-compliant labeling 9 9

10 PharmaSuite Dispense Supported Scales Mettler SICS protocol (typically lab scales) MMR protocol (scales terminals ID1, ID2, ID3, ID5, ID7, IND) IDNet protocol (scales terminal GD12) Sartorius xbpi protocol SBI protocol MP8 protocol Other communication protocols Support for other protocols requires implementation of a scale driver (see Technical Manual Configuration and Extension) 10 10

11 PharmaSuite Main Concepts of the Execution Cockpit Start of product related control recipes Start of unit related workflows Ticker panel 11

12 PharmaSuite Main Concepts of the Execution Workbench Execution of operations / phases at a unit Phase specific interaction with the operator or equipment 12

13 PharmaSuite Main Concepts of the Execution Navigator Historical list of activities at the unit Allows to review batch record details Allows to trigger correction functions on the executed batch record 13

14 PharmaSuite Main Concepts of Production Response Exception handling and tracking Each phase comes with a specific set of exception handling to address typical operational issues Validation of operator or equipment input can raise system-triggered exceptions Operator can create user-defined exceptions at any time Operator can always pick from usertriggered exceptions Batch record corrections are tracked as post-completion exceptions Level of signature needed is defined by risk-assessment 14

15 PharmaSuite Main Concepts of Production Response Review by exception Real-time visibility of exception through quality dashboard enables preventive review strategy Comment capability for QA and operational personal 15

16 PharmaSuite Main Concepts of Production Response 16

17 PharmaSuite Main Concepts of the Recipe Designer S88 based graphical workbench Modeling with sequential function chart (SFC) methodology Easy navigation within the recipe Optimized presentation of the recipe for different needs Re-usability of recipes or part of the recipe Approval of building blocks / manufacturing recipe Locking of parameters Re-usability on all levels of the recipe System guidance throughout the recipe design Setlist to stage all necessary recipe elements Preview of the recipe presentation to the operator Real-time messages pointing to structural recipe issues 17

18 PharmaSuite Main concepts of the Recipe Designer Expression editor Formulas combining phase output for calculations and conditions Open architecture New functional capabilities / building blocks can be deployed Recipe Lifecycle throughout Dev/QA/Production environments Import/export based on B2MML History keeping of approval steps Reporting capabilities Complete manufacturing recipe report Parts of recipe can printed 18

19 The ISA-95 Hierarchy Level 4 Business Planning and Logistics, Plant Production Scheduling, Operational Management, etc. Level 3 / 4 interface ERP Integration Gateway PharmaSuite Level 3 Manufacturing Operations Management Dispatching Production, Detailed Production Scheduling, Reliability Assurance, etc. ISA S95 Level 2 Batch, Historian, PlantPax and ControlLogix Level 1 Batch Control Continuous Control Discrete Control

20 PharmaSuite Typical ERP-MES Touchpoints Master Data Management Material Management Production Planning Quality Management Finance / Controlling HR Business System JCA Adapter Create / update material Create / update BOM Release process order Update process order Update inventory Update process order Finish process order Material item BOM Process order Process order status Check quality status Material consumed Material produced Material consumed Times Process order status Insert / update material Insert / update BOM Create process order Start process order Identify material Add material Report material produced Finish process order EIG ERP Integration Gateway Recipe Design Dispense Recipe Execution EBR Quality Management Production Analysis Platform 20

21 PharmaSuite ERP Integration Gateway QM MM PP PP-PI SD APO JCA Adapter EAI Middleware like WebSphere, BizTalk, etc JCA Adapter SAP PI (formerly XI) JCA Adapter BAPIs RFCs IDOCs Web Services SAP ECC Web Services BAPIs RFCs IDOCs SAP MII esoa ESA Services Web Services Web Services Adapter Adapter Adapter Adapter Adapter Adapter Adapter ERP Integration Gateway Adapter Step2 Step1 Step3 Platform

22 PharmaSuite - Platforms 4.0 Client operating system Microsoft Windows - 7 Professional SP1 (64-bit) Microsoft Internet Explorer 8.0 (32-bit) Microsoft Windows - XP SP3 (32-bit) Microsoft Windows - 7 Professional SP1 (32-bit) Microsoft Internet Explorer SP1, 7.0 Qualified Supported Application server JBoss Application Server Enterprise Application Platform GA IBM WebSphere Application Server Qualified Supported Server operating system Microsoft Windows Server (Standard Edition) R2 SP1 (64-bit) Microsoft Windows Server (Enterprise Edition) R2 SP1 (64-bit) Microsoft Windows - XP SP3 (32-bit) Red Hat Enterprise Linux (64-bit) - AS5 Update 5 Qualified Supported RDBMS Oracle 11g Server (Enterprise Edition) - version (64-bit) Oracle 11g Server (Enterprise Edition) - RAC version (64-bit) Microsoft SQL Server (Enterprise and Standard Editions) R2 SP1 (64-bit) Microsoft SQL Server (Enterprise and Standard Editions) R2 SP2 (32-bit) Qualified Supported 22

23 PharmaSuite Innovation for the Recipe Life Cycle Process Design Recipe Design Analysis Time to results for every user Review & Approval Planning & Dispatching Recipe Execution Building Block SDK 23

24 Questions PharmaSuite Mark Drochek Information Solutions Technical Consultant November 5, 2012