The future of. OpenLAB! Bernhard Etrich ChemStore Program Manager

Transcription

1 The future of ChemStore is OpenLAB! Bernhard Etrich ChemStore Program Manager Christoph Nickel Industry Marketing Manager Life Science Informatics and Software Solutions Page 1 ChemStore future direction Agilent Restricted April 11th, 2008

2 Agenda Welcome and Introduction Stephen D.Brown Future of ChemStore is OpenLAB Christoph h Nickel ChemStore Roadmap Bernhard Etrich ChemStation/OpenLAB benefits Christoph Nickel ChemStore Database Migration Bernhard Etrich Promotional offer Stephen D. Brown Questions and Answers Page 2 ChemStore future direction Agilent Restricted April 11th, 2008

3 THE FUTURE OF CHEMSTORE IS OPENLAB Page 3 ChemStore future direction Agilent Restricted April 11th, 2008

4 ChemStore Situation Standalone and C/S add-on database for ChemStation data Designed as bridge to future Agilent CDS Robust, mature application >550 systems sold with >8000 clients Fully featured for regulated Pharma Architectural and programming g standards from late 90 s Mandatory link to ChemStation Revision upgrades Not scalable to large (>90 instruments, t > 30 users) installations Difficult to use (continuous switches ChemStation <- >ChemStore) Page 4 ChemStore future direction Agilent Restricted April 11th, 2008

5 Customer situation and Agilent OpenLAB UV-vis MS Office PDF Instruments GC/MS CE LC/MS ICP-MS Content Legacy Data GC LC Images Drawings Research Different instrument techniques from multiple vendors Content from many different sources in different formats Processes Regulatory needs Reduce IT costs Increase throughput Services The answer OpenLAB: Multi-vendor, multi-instrument data management solution for the complete Lab LSCA Software and Informatics Agilent Restricted

6 The role of OpenLAB EnterpriseContentManager ECM in the integrated lab Project Research Data Corporate Records Management CDS Partners, Customers Central storage for all data Electronic Notebook LIMS Validation Plan SOPs Manufacturing Batch Records Clinical Trials Instrument Data, Lab Reports offering final analytical crossapplication reporting central raw data management and archiving enabling for the paperless lab! and workflow automation Page 6 October 29, 2008 OpenLAB BPM Agilent Restricted

7 Future direction for ChemStation Plus ChemStation/OpenLAB EnterpriseContentManager ECM The situation: With ChemStation Rev.B ECM as data backend will provide superior usability, full compliance, and more powerful functionality for ChemStation: Better workflow support for improved efficiency More flexibility unlimited number of users on multiple sites Reduced IT costs through easier user administration and less software applications to support (GC-MS Sec Pack, UV- Vis Sec Pack, ICP-MS ) Improved compliance (user privileges, data integrity) Full suite of migration services available Situation today Agilent recommendation Page 7 ChemStore future direction Agilent Restricted April 11th, 2008

8 What if I do not want to move now? Relax! Upgrade to ChemStore B to support B ChemStation Regular ChemStore Service Releases keep compatibility with new OS, DB and future ChemStation New functionality might not be available with ChemStore But plan for the future! Page 8 ChemStore future direction Agilent Restricted April 11th, 2008

9 ChemStore Roadmap Bernhard Etrich ChemStore Program Manager November 2008 Page 9

10 ChemStore Roadmap Transition period May 2011 Obsolescence of ChemStore Server Service Packs for Rev. B server On-going Service Packs to continue Oracle compatibility January 2015 End of support of ChemStore server January 2009 Client Rev. B SP 1 SP 2 SP 3 Support of: Microsoft Vista and XP SP3 ChemStation B On-going Service Packs to continue ChemStation compatibility SP1 for Client Rev. B SP2 for Client Rev. B January 2014 Rev. B End of support ChemStore Roadmap November, 2008

11 CHEMSTATION/OPENLAB ECM BENEFITS Page 11 ChemStore future direction Agilent Restricted April 11th, 2008

12 ChemStation B Get more out of your ChemStation! More means: Seamless fit from non-regulated to strictly regulated environments Enhanced Workflow support Better usability & faster results review Additional Benefits: New custom fields for custom data per sample / compound Save manual integration in data files New signal overlay (incl. OpenLAB ECM data) Partial acquisition sequence Manual Integration Demo Improved OpenLAB ECM integration Central data management & user administration (OpenLAB ECM) ECM OpenLAB ChemStation B Agilent Confidential May 2008

13 ChemStation B Add-on Modules Add the Functionality according to your needs ChemStation B with : a) ChemLaunch b) OpenLAB ECM c) OpenLAB Intelligence Reporter provides: Lab-wide remote instrument management (a) Reduce validation & upgrade costs [terminal server] (a) Central Master Method Management (b) Improved configurable compliance (b) Improved method & result traceability / audit trails (b) Configurable access security (b) Cross-sequence report with advanced calculations (c) Further demo videos on the web: OLIR Demo on Agilent.com ChemLaunch Demo coming soon ChemStation B Agilent Confidential May 2008

14 What s New in ChemStation B.04.01? General Functionality Regulatory Compliance Save manual integration in data files Mandatory log-in/connection to ECM Signal overlay (incl. ECM data) Session Lock Partial acquisition sequence Granular ChemStation user roles and E-methods for GC ChemStation privileges* Improved ECM workflow* Advanced Reporting Custom fields (sample- and compound-related) Hardware Support New 1200 Well-plate sampler New 1200 VWD Method audit trail functionality Results audit trail* All features are configurable* Infrastructure New Installation Windows Vista ChemLaunch (Citrix Terminal Server) * Not available with ChemStation/ChemStore ChemStation B Agilent Confidential May 2008

15 ChemStore versus OpenLAB ECM data management ChemStation/OpenLAB ECM Pro: Full scalability Easier administration (NT domain, SQL or Oracle) Manages also GC-MS, ICP-MS and other instrument records Better workflow support More comprehensive compliance functionality Digital signature for reports Supports new relational database reporting add-on OLIR Future proven ChemStation (B.03.02) /ChemStore (B SR 2) Pro: Well-established system Mature Tight integration of ChemStation/ChemStore Built-in reporting module Feature-complete for regulated Pharma Future safe Page 15 ChemStore future direction Agilent Restricted April 11th, 2008

16 Why replace ChemStore with OpenLAB ECM? Functionality in ChemStation/OpenLAB ECM superior to ChemStation/ChemStore OpenLAB provides a comprehensive answer to data management needs in today s laboratories Better Reporting with OLIR Future-proven investment: OpenLAB ECM OpenLAB ECM provides a modern, web-based, fully scalable architecture OpenLAB ECM will become data management back-end for all Agilent (ChemStation family, MassHunter) data systems OpenLAB ECM will be the back-bone of Agilent s future CDS Page 16 ChemStore future direction Agilent Restricted April 11th, 2008

17 ChemStore Data Migration Service Bernhard Etrich ChemStore Program Manager November 2008 Page 17 ChemStore Migration Service Agilent Technologies

18 1. The Situation Page 18 ChemStore Migration Service Agilent Technologies

19 2. Solution A: Virtualize your server Pros: Cons: Makes you independent of server hardware upgrades Cost effective Minimal training requirements Minimal maintenance Limited validation effort Upgrade to the latest ChemStore revision to extent the support period Support risk in case of record retention periods > 5 years for data review only validation and training effort for 2 data systems Page 19 ChemStore Migration Service Agilent Technologies

20 The Solution B: Migrate ChemStore Data in Agilent OpenLAB ECM ChemStore database extraction service The ChemStore database gets rolled out in a flat file system The file format changes from proprietary to generic ChemStation format Data gets uploaded to Open LAB ECM Includes Compliance Services Migration is delivered by Agilent s Professional Services Organization (PSO) On-site Remotely (under development) At Agilent Page 20 ChemStore Migration Service Agilent Technologies

21 The Solution: Migrate ChemStore Data into Agilent OpenLAB ECM You can turn off a ChemStore C/S database and fulfill the following compliance requirements: Retention: ti Long-term archive of all raw data, meta data (methods, sequences, batches), results and approvals (esignatures, audit trails) Protection: User restricted access to legacy data in ECM Documentation: Review of chromatograms, results and audit trail Page 21 ChemStore Migration Service Agilent Technologies

22 The Product: ChemStore Data Migration Service The Data Migration Service is delivered by Agilent s Professional Services Organization (PSO): 1. Extraction from ChemStore PSO will analyze and extract your database Migrate your database with the ChemStore Data Migration Service!! 2. Import into Agilent Open LAB ECM Extracted data will be imported into OpenLAB ECM PSO 3. Agilent validation protocol available after successful migration 4. Result review with ACAML Viewer, reprocessing in ChemStation Page 22 ChemStore Migration Service Agilent Technologies

23 Your Benefits You have all your data in one repository (Agilent Open LAB ECM) Future proven review of chromatograms, results and e-signatures Smooth integration into one solution for the whole laboratory Switch off ChemStore server(s) Page 23 ChemStore Migration Service Agilent Technologies

24 Summary: Why ChemStation with OpenLAB? Better compliance, more efficient lab operations at lower costs Fully scalable from workgroup to enterprise System transfer is easy and nondisruptive Full data migration service for ChemStore data into Agilent Unified XML format (ACAML) for review and reprocessing available Start making gyour future plans NOW to keep ahead of the curve! Page 24 ChemStore future direction Agilent Restricted April 11th, 2008

25 Details about ChemStation add-on modules Details about ChemStore migration Detailed compliance comparison ChemStation/ChemStore ChemStation/OpenLAB ECM BACKUP SLIDES Page 25 ChemStore Migration Service Agilent Technologies

26 ChemLaunch and OpenLAB Intelligence Reporter DETAILS ABOUT CHEM STATION ADD-ON MODULES Page 26 ChemStore future direction Agilent Restricted April 11th, 2008

27 ChemLaunch Add-on Module Drive Down IT and Validation Costs Increase efficiency with: remote instrument access central instrument control use of ChemStation thin clients (terminal server environment) Benefits: Run ChemStation in a Web Browser Reduce validation costs Reduce Lab downtime while upgrading Reduce IT support costs More efficient instrument usage Simplified lab administration Enable use of Mac or Linux clients Fully supported by Agilent Price estimate : 35 K$ incl installation, validation, training and SMA excluding ChemStation upgrades IQ/OQ for 10 ChemStation is ~32 k$ for 15 instrument sessions ChemStation B Agilent Confidential May 2008

28 OpenLab Intelligence Reporter Get Results Fast! Fast and efficient with: Reporting database in ECM Simple and advanced calculations cross and within sequence Interactive report elements and content based result presentation Trend charting Benefits: Faster from acquisition to final report Typical Pharma and other reports right from the CDS Lab-wide asset reporting (instruments, columns, ) Improved report quality & compliance Access to all results in reporting database through built-in views Supports Oracle and MS SQL Server Price estimate : 6K $ (system with 15 ChemStations) ChemStation B Agilent Confidential May 2008

29 ChemStation/ChemStore versus ChemStation/OpenLAB ECM DETAILED COMPLIANCE FEATURE COMPARISON Page 29 ChemStore future direction Agilent Restricted April 11th, 2008

30 21 CFR Part11 Requirements Feature Comparison Feature ChemStation Plus (with Security Pack) ChemStation B SR1 (with ECM) ChemStation B (with ECM) Method & Result versioning Yes 1) Yes 3) Yes Detailed method audit trail N/A 2) No Yes Manual integration audit trail Yes No Yes Time based session lock Yes No Yes User roles management Yes No Yes User authentication Yes Only for ECM login Yes Signing results (approve/reject) Yes Yes (in ECM) Yes (in ECM) Locking data Yes Yes (in ECM) Yes (in ECM) Copying data in human readable Yes ChemStation PDF ChemStation PDF format report report 1) Automatic Upload after any kind of result creation 2) Rudimentary method audit trail that requires SOP: Method Change History All methods are stored with the results and methods are viewable in ChemStore 3) Automatic upload after acquisition and sequence reprocessing Page 30 ChemStore future direction Agilent Restricted April 11th, 2008

31 21 CFR Part11 Requirements Feature Comparison Feature ChemStation Plus (with Security Pack) ChemStation B SR1 (with ECM) ChemStation B (with ECM) Compliance for other data in Lab x Yes Yes Complete Record security Yes Yes Computer generated, unalterable Yes Yes audit trail of all system acitivies Central data management: Store and organize data from multiple ChemStation installations in one central repository Yes Yes Yes Restrict access to ChemStation data stored in Yes Yes Yes Database based on access rights Restrict access to reports stored in Database based on access rights Securely store ChemStation data in Database under revision-control Securely store reports in Database under revision-control No reports present Yes Yes Yes Yes Yes No reports present Yes Yes Page 31 ChemStore future direction Agilent Restricted April 11th, 2008

32 Details about ChemStore migration BACKUP SLIDES Page 32 ChemStore Migration Service Agilent Technologies

33 3. Migration process 1. Submit basic information to Agilent Software revision of ChemStore Software revision of Agilent ECM ChemStore Data Base History your envisioned migration schedule Cut-off date (in case of a partial extraction) 2. Diagnose Phase performed with the help of the ChemStore Admin Tool ChemStore database export size how many and which archives to retrieve, size of those archives Number of runs Report on this should be send to PSO Page 33 ChemStore Migration Service Agilent Technologies

34 3. The Process 3. PSO sends offer ORACLE Database Export + Archive units Database report used as a bases for the offer Provide Schedule / Migration plan Offer includes appropriate exchange media (typically USB drive) The Offer mentions all archives, which need to be retrieved 4. Migration preparation You will receive appropriate exchange media (typically USB drive) Database must be retired. No further acquisition or reprocessing on retired production database Oracle Administrator creates ChemStore DB ORACLE Export and restores all archive files to the exchange media Page 34 ChemStore Migration Service Agilent Technologies

35 3. The Migration Process Archive units ChemStore Trace database ChemStation Sequence containers Compliance Service retired ChemStore Database (updated to rev. B.04.01) extrac t ChemStation Single Run container ACAML Catalog file zip SSI ZIP containers upload, filtering Agilent OpenLAB ECM ChemStation B Analytical Data Viewer Page 35 ChemStore Migration Service Agilent Technologies

36 4. After Migration: View Results Set up a search in Agilent ECM View data with Analytical Data Viewer The overview lets you sort your data by fields If you double-click on a row you open your data in the details view Page 36 ChemStore Migration Service Agilent Technologies

37 4. After Migration: View Results Details show your results and all related files If you click on a signal, the viewer will open View audit trails, approvals and files Page 37 ChemStore Migration Service Agilent Technologies

38 Data Reprocessing with ChemStation ChemStation B.02.01: Single run processing and auto-stepping of sequence runs ChemStation B SP1: Sequence reprocessing of ChemStore legacy data Page 38 ChemStore Migration Service Agilent Technologies

39 ChemStore / Agilent ECM Migration Product Compatibility Software Application Revision number ChemStation A.06 or higher comments ChemStore B Microsoft Access databases will be (Oracle based only) B040 B.04.0x migrated to an Oracle DB first ECM 3.02.xx Reprocessing Software Application ChemStation B SR1 Reprocess sequences and single runs or higher EZChrom or OpenLAB ICM Single run chromatogram trace (.CH file) can be reviewed Page 39 ChemStore Migration Service Agilent Technologies

40 5. Support and Compliance: Migration i Verification i Protocol The migration process is formalized and documented. Agilent creates a Migration Verification Protocol which allows detailed recording of the migration process. Delivery The Migration Verification Protocol is paper based. Any deviations of the described workflow are documented by the Agilent service engineer. It also contains any log files created by tools used. Page 40 ChemStore Migration Service Agilent Technologies