CPSA Digest 2003

Day 3

WeOC2

Global Strategy for Analytical Data Management

Defining the Challenge
Centocor is a small biopharmaceutical company that is merging within a bigger company (Johnson & Johnson) following an acquisition. Laboratories are distributed all over the world and each company has its own culture and approaches. The challenge is "How to set up a global LIMS for a distributed QC environment? " The data landscape is illustrated in the figure below. There are many data generators, including both paper data as well as electronic data via a LIMS system. Ideally, one system is desired that pulls all data sources together.

Current Systems
An evaluation of the current systems at each site yields the following information:

• Raw data generators ­ Agilent ChemStation and NuGenesis Archive v5.1
• Sample management systems ­ Beckman LabManager LIMS & Agilent ChemStation LIMS
• Reporting ­ Brio v6.6
• Report repository ­ NuGenesis Unify/Vision v5.2
• Compliance ­ Secure Instrument Desktop

Objectives for a Global Strategy

• Share & Exchange Analytical Information with Other Sites Globally
• Provide Global Access to QC Databases Across Enterprise
• Provide Management with Ability to Trend & Analyze Results
• Deploy a Global LIMS with a Distributed QC organization
• Align and Leverage Automated Processes across Sites
• Leverage Costs, Resources and Systems across Sites
• Utilize Off-the-shelf Solutions or Successful Systems at Sites
• Provide Long-Term Support for Applications and Technology

Benefits of a Global Strategy

• Facilitate Creation of a Distributed QC Laboratory
• Provide Consistent Automation Approach Across all Sites
• Provide Management with High-Level View of Data
• Link Results in Reports to Raw Data Source
• Minimize Compliance Risk and Ensure Long-Term Integrity of the Data

Seven Strategic Areas for Focus

1. Raw Data Management
   • Instruments acquire data
2. Sample Management ­ LIMS
   • Samples may be of different types (chemical, biological, microbiological) and/or split among global sites, however they all must be received/analyzed/archived using databases with sample audit trails
3. Analytical Report Management
   • Provides one reporting tool for all analytical sources of data
   • Allows multiple databases t
   • be queried
   • Allows reports t
   • be consolidated across multiple databases
4. Analytical Data Repository
   • Centralized data repository allows all paper printouts tbe automatically captured and indexed
   • Metadata can be extracted, processed and exported into other database repositories
   • Multiple reports electronically presented/reviewed/signed as one
5. Regulatory Compliance
   • Secure Instrument Workstation
   • Application Centric Security vs PC-based
6. Disaster Recovery
   • Redundancy reduces risk
   • Servers at different Global Sites
   • Disk Storage (SAN)
   • Backup & Recovery
   • Validated Server for Development or Disaster
   • Sandbox Server
7. Support
   • Vendors
     • Application (LIMS, NuGenesis, Velquest, Stelex)
     • System (hardware, O/S, database, network)
   • o Keep Pace with Technology Changes with Compliance
   • Multi-shift, multi-site Coverage, 24 x 7
   • Internal
     • IM (Server, O/S, Oracle, Network, Infrastructure)
     • QC
     • Application (outside of QC)

Defining Issues

• Available resources from each site; manpower; IQ/OQ
• Site sponsorship; reporting structures are not the same among laboratories
• Site Agreements on Issues (QC)
• Long term support; need staff & consultants to support this new technology
• Paradigm Shift to Paperless/Electronic Signature; tough transition; people want to hang on to that paper record; only official report is the one having "e-signature"

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