Enterprise Content Management

Transcription

1 Enterprse Content Management for the Laboratory Jm Mller Drector of Informatcs and Software Aglent Technologes Branden Humphrey Global Data Archve Program Manager Pfzer Global Research

2 The content exploson More data wll be created over the next three years than n the prevous 40,000 combned 75% s unstructured PETABYTES Source: UC Berkeley, School of Informaton Management & Systems, 2003 Page 2

3 and the unfortunate truth Organzatons store ther content n too many separate locatons Valdaton Plans Research Data Corporate Records Electronc Notebooks LIMS Data Partners, Customers SOPs Project Management Marketng Collateral CDS Clncal Trals Instrument Data, Lab Reports Manufacturng Batch Records IP Records Page 3

4 Challenges n dealng wth all ths data How can you logcally organze ths data? How can you make all the data safe and secure? How can you make all the dfferent data searchable and shareable? How can you make all the data vewable from dfferent places? How can you handle laboratory data as part of your company s busness processes? Page 4

5 ECM connects the dsconnected enterprse Research Data Corporate Records Project Management Electronc Notebooks Valdaton Plans LIMS Data CDS SOPs Partners, Customers Marketng Collateral Manufacturng Batch Records Clncal Trals Instrument Data, Lab Reports IP Records Page 5

6 Wth nstant, secure access to your data GC/MS GC MS Offce Legacy Data UV-vs LC/MS LC PDF ELN Images ICP-MS Lab-on-a Chp CE LIMS Research Drawngs Intranet Internet Page 6

7 Gettng data nto the ECM Manual addton Hardcopy Prnter ECM Prnt Servce Automatcally through Scheduled Import Servces Drect transfer from external database systems, e.g. LIMS Prnt PDF fles drectly to the ECM Page 7

8 Organzng the ECM repostory Intutve herarchy - Account - Locatons - Cabnets - Drawers - Folders Confgure to ft your needs Data organzaton by Project Data organzaton by Department Page 8

9 Accessng, vewng and managng data Double Clck to Vew Page 9

10 Accessng, vewng and managng data Double Clck to Vew Page 10

11 Accessng, vewng and managng data Rght clck to access common functons Page 11

12 Indexng data for easy retreval Fle mported Metadata extracted and saved to the database Header Operator ID Run Date Method Method Revson Instrument Instrument ID Frmware verson Make Model Sample Sample ID Sample Type Sample Source Attrbute Extracton Servces avalable for many fle types Page 12

13 Indexng data for easy retreval Fle mported Metadata extracted and saved to the database Fle placed n the secure repostory DB updated wth fle ponter Header Operator ID Run Date Method Method Revson Instrument Instrument ID Frmware verson Make Model Sample Sample ID Sample Type Sample Source Lnk Attrbute Extracton Servces avalable for many fle types Page 13

14 Indexng data for easy retreval Fle mported Metadata extracted and saved to the database Fle placed n the secure repostory DB updated wth fle ponter Index can be re-keyed to add attrbutes Lnk Header Operator ID Run Date Method Method Revson Instrument Instrument ID Frmware verson Make Model Sample Sample ID Sample Type Sample Source Attrbute Extracton Servces avalable for many fle types Page 14

15 Search tools to mne heterogeneous data Fnd exactly what you need fast!! Page 15

16 Keepng your content secure & complant Logn securty Audt tral Electronc sgnatures Secure (SSL) data transfer Record verson control Check n / Check out Access controlled through roles Page 16

17 Managng Excel spreadsheets n a regulated envronment Securty access to cells consstent wth the ECM securty model Complete cell-by-cell audt tral Lmted user nteracton (data entry only) Page 17

18 Supportng SAFE (Secure-Access-for-Everyone) New global standard for legally bndng electronc sgnatures from a consortum of bo-pharmaceutcal companes Used n leu of wet sgnature and notarzaton for hgh securty applcatons and protecton of ntellectual property Key components: - Secure ECM repostory - SAFE esgnature Plug-n - Kyberpass TrustPlatform - Trusted Thrd Party PKI Infrastructure Page 18

19 Managng laboratory busness processes Streamlne, automate, and optmze laboratory busness processes Defne, confgure and deploy wthout programmng Applcatons: - Complance - Core process and systems consoldaton - Sx Sgma qualty mprovement Busness Process Manager example Page 19

20 Managng the complete lfecycle of electronc records Metadata Fle Server Database Archve Retenton Polcy Tme ECM supports herarchcal storage management and multple retenton polces Page 20

21 Preservng legacy data wth TNF Technology Neutral Fle Format: a new standard format based on XML Convert propretary chromatography records (raw data, results, meta data) to TNF for preservaton and reuse Converters avalable for HPLAS and Thermo MultChrome*; next releases wll be Beckmann Peak Pro, and PE Turbochrom TNF Servce Converter 1 Converter 2 SSIZp Converter 3 Converter 4 TNF SSIZp Page 21

22 ECM archtecture that grows wth you from sngle laboratory Page 22

23 to global deployment Page 23

24 3 thngs to remember about ECM Provdes a secure, central repostory and rch content servces for capturng, managng, archvng, collaboraton and re-use of busness crtcal nformaton Improves complance wth corporate and regulatory requrements for managng electronc records Enhances productvty, ncreases operatonal effcency and streamlnes laboratory busness processes Page 24

25 Aglent Laboratory Informatcs Page 25

26 Aglent Certy ECM Web Semnar Data Archval Challenges Branden Humphrey Lab Data Archve Program Manager 1

27 Dscusson Topcs The problem Scope of the project Informaton Archtecture Types of data to manage Implementaton Overvew How ECM met our needs 2

28 The problem How many people use the Internet and fnd t nvaluable? 3

29 The problem How many people use the Internet and fnd t nvaluable? How many people get frustrated when tryng to fnd nformaton on ther own PCs or company fle shares? 4

30 The problem Huge amounts of data to collect and catalog Constant change n lab nstruments Data physcally located everywhere Lmted knowledge that the data exsts Dffculty sharng data Scentsts dstracted by data management dutes 5

31 The problem So, how do we collect all of ths data 6

32 The problem So, how do we collect all of ths data wthout creatng a huge Data Landfll! 7

33 Scope of the Project Three countres, 2 languages Deploy to Pfzer Global R&D for 4 Dscovery 4 Safety Scences 4 PDM (Drug Metabolsm) 4 Pharmaceutcal Scences Use ranges from real-tme to true archval Global data sharng search and retreval 8

34 Informaton Archtecture Vsualzaton Tools Data Publshng Data Warehouses: Locked down Fnal Results Transactonal Databases: LIMS, enotebooks Certy ECM: Raw Data, Spectra Processed Data Fles 9

35 Types of Data to Manage All types of laboratory data Chromatography and Mass Spec to Dfferental Scannng Calormetry and Electron Scannng Mcroscope Text, graphcs, raw and bnary data fles Standard, custom and propretary formats Varous Record Retenton reasons 4 Regulatory, 4 Legal / Patent Defense 4 Busness value 10

36 Implementaton Overvew Deploy separate regulated and non-regulated systems Use Federated Archtecture 4 Global fle catalog 4 Ste-based fle storage 4.5 TB/Year) Run agents on vrtual machnes Leverage Aglent to perform system nstallaton Defne Metadata Standards Develop Dscovery Search and Lnk API 11

37 How ECM met our needs Automates Fle Catalogng 4 Can customze to any fle format Automates schedulng of data collecton Provdes secure, hghly scaleable platform Permts global workload sharng Supports ntegraton wth other applcatons Off-loads scentst of data management dutes Enables centralzed support model Enables hardware consoldaton, tered storage 12

38 Questons 13

39 Your moderator s Davd Markovtz, Co-Founder and Presdent Insttute for Effectve Innovaton servng the FDA regulated ndustres World-class tranng, consultng and coachng Proven tools to equp your work groups and teams Innovaton Boot Camp GMP Tranng System Ready-to-Use Modules Desgned for Internal GMP Tranng FREE sample - Go to nfo@gmptranngsystems.com

40 Thank You All attendees for your attenton Our panel -Branden Humphrey, Pfzer Global Research, for a very nterestng case study -Jm Mller, Aglent Technologes, Drector of Software and Informatcs -Davd Markovtz, Insttute for Effectve Innovaton, for moderaton

41 Please jon Aglent Technologes for future webcasts later n 2005 s For more nformaton on Certy ECM vst: For more nformaton on the Aglent s complance program vst: