Data and Documentation Team

1. Data and Documentation Team A Life Sciences Industry Initiative David Kwilosz Eli Lilly and Company

2. The Data and Documentation Collaboration Team is a group of end users and engineering firm representativescommitted to creating a standard definition for data and document requirements associated with new assets to be used in the life sciences industry.

3. Here is: • Our standard documentation package • I need: • Drawing • Manual • Certificate End User Engineering Firm Vendor • Please supply: • DDR # 110-112 • DDR # 207A & B • DDR # 425 Example:End User Requires Data & Documentationto Support Installation, Commissioning, Operations, and Maintenance of New Assets

4. I need: The manual… • Here is: • What you asked for….and it will cost you $$$$$ extra We don’t have any documentation on that instrument… End User #2 End User #2 End User #2 End User #4 End User #5 End User #3 End User #3 I’ll take the standard package… • I need: • EU2-1A • EU2-2B • EU2-3C I don’t know what I need…. They are available on our website • Here is: • Our standard documentation package • Here is: • Our standard documentation package • I need: • Drawing • Manual • Certificate End User End User End User Engineering Firm Engineering Firm #2 Engineering Firm Engineering Firm Engineering Firm #2 ???? Vendor #3 Vendor Vendor Vendor Vendor #6 • Please supply: • DDR # 110-112 • DDR # 207A & B • DDR # 425 They are available on our website Vendor #4 Vendor #2 Vendor #2 Vendor #7 • Here is: • Our standard documentation package • I need: • VDR # 87 • VDR # 89 • Please supply: • DDR # 110-112 • DDR # 207A & B • DDR # 425 • Please supply: • DDR # 110-112 • DDR # 207A & B • DDR # 425 Vendor #3 Vendor #3 Vendor #5 • I need: • VDR # 87 • VDR # 89 • I need: • VDR # 87 • VDR # 89 • I need: • VDR # 87 • VDR # 89 • Please supply: • DDR # 110-112 • DDR # 207A & B • DDR # 425 • I need: • VDR # 87 • VDR # 89 Reality:Multiple Participants = CHAOS!

5. Identified Problem • End user does not receive documents required for installation, commissioning, operation, and/or maintenance of new asset • Engineering firm wastes man-hours on every project identifying documents required by customer • Instrument/equipment supplier wastes man-hours attempting to satisfy varying document requirements for assets

6. Proposed Solution • Establish a standard set of data and document requirements for new assets, based on asset type and its intended use • Allow for additional or less data and documents, as appropriate, by company/project, but use as a common baseline • Publish the standard and encourage its use by end users, engineering firms, and inst/equip suppliers • Benefits: • Reduces excess “paper” for like items • Drives appropriate level of consistency andflexibility across sites and vendors • Supports future efficiencies via technology enablers

7. Team History • Data and Documentation Collaboration Teamformed in early 2007 by Lilly and Jacobs Engineering • Goals: • Create standard definition for data and documentation requirements associated with new assets • Pharma companies to use these requirements as baseline for use on capital projects • Engineering firms to integrate these requirements into their business practices across their offices • Team to assess use of technology tools to take advantage of these standards • Align with recognized industry group(s) • Make deliverables easily available for public use

8. Data & Doc Team Members • End Users • Lilly, Merck, Genentech, Abbott • Engineering Firms • Jacobs, CRB, CH2MHill • Affiliated SME Task Groups • Instrument Suppliers (under BPE PI Sub-Committee) • Mettler-Toledo, JM Canty, Anderson Instrument, Flow Products LLC (Integrator), Endress + Hauser, Emerson Process Management, Weed Instrument • Equipment Suppliers (under BPE SD Sub-Committee) • Allegheny Bradford, Steris, SPX Process Equipment, Millipore, Getinge, DCI Inc., Wilden Pumps, Pall

9. Data & Doc Team ISPE C & Q COP Adopted as a Task Team End Users EPC Vendors Published Recognized Recommend Obtaining Input from Vendors Assigned Vendor Task Group to Review VDR Offered to Publish Instrument VDR Evolution of Team ASME-BPE

10. Initial Deliverable - VDR for Instruments(to be published in 2009 ASME-BPE Standard)

11. Next Steps: • Complete VDR for Equipment • Identify Documentation Req’ts for Vendor Packaged Equipment (skids) • Identify Data Requirements for Instruments, Equipment, VPE • Publish in 2012 ASME-BPE Standard

12. How can Life Sciences Industry Benefit from Engagement with Other Industries (oil/gas, nuclear, etc.)? Common problems require common solutions: • Instruments, equipment, VPE are common across industries – few requirements are unique to life sciences • Majority of EPC firms and vendors provide to many industries, not just life sciences • Information and control systems are used across industries – alignment across industries could allow for development of common, rather than customized, platforms