Business Approach to SDMSutilization. Organization
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1 Business Approach to SDMSutilization in a GLP Research Organization Theo Noij Head of Chemistry, WIL Research Europe Associate Professor, AVANS Univ. Applied Sciences
2 Understanding SDMS Understanding our business
3 WIL Research: who we are Contract Research Organization; #7 global player; >1,000 staff Safety research to support innovative pharmaceutical, chemical and agrochemical companies Focus on Toxicology WIL Research Europe = previously NOTOX WIL Research Company Fairfield (NJ), USA WIL Research USA Ashland (OH), USA WIL Research EU (NOTOX) Den Bosch, NL QS-Pharma Boothwyn (PA), USA Biotechnics Hillsborough (NC), USA Midwest BioResearch Skokie (IL), USA
4 WIL Research Europe 300 staff In-vivo toxicology, in-vitro toxicology, eco-toxicology, geno-toxicology, phys-chem characterization, analytical chemistry, regulatory support 30 years experience GLP and AAALAC accreditations
5 Chemistry laboratories Bioanalysis -Pharmaceuticals/metabolites in bloodand tissues - UPLC-MSMS(Sciex, Waters) -Analyst, LabWareLIMS -12 staff Environmental Fate -Behiourof pharmaand agro in environmental systems; radiolabelled - HPLC-RD, LSC, TLC, HPLC-MS, acc.mass MS - Laura, Quantasmart, XCalibur -8 staff Analytical -Chemicals (pharma, chemical, agro) in formulations, materials and environmental - UPLC-MSMS(Waters), GC-MS, GC and ICP- MS (Agilent), UPLC/HPLC (Waters) - EmPower, MassLynx, Chemstation -20 staff Physical Chemistry - PhysChem characteristics (Bp, visc, flamm, Kow, sol, corr, expl, ) -a.o.dsc, TGA, IR, UV; manyothers visual observations and non-computerized -TA Advantage, Shimadzu IR, Cary Win UV -4 staff
6 GLP Good Laboratory Practice Study results retrievable from first record onwards Experimental conditions documented in detail All methods, instruments and software validated Study director central point of control & scientifically accountable
7 Equipment 4x Waters Acquity UPLC + Waters Xevo TQ-S MSMS 2x Waters Acquity UPLC + Sciex API 5000 MSMS 1x Waters Acquity UPLC + Sciex API 3000 MSMS 1x Agilent Sciex API 3000 MSMS 1x Waters Acquity UPLC + Waters TQD MSMS 2x Waters Alliance HPLC + Perkin Elmer Radio Detector FloOne Beta 525 and 1x LabLogic β-ram U(H)PLC-UV, -PDA, FD, -ELSD: 7x Waters Acquity UPLC H-class 8x Waters Alliance 2695
8 Connectivity Agilent GCMS Chemstation Agilent ICPMS Chemstation.and many other software applications from other research areas (toxicology, QSAR s, statistics, ) Waters Empower Thermo XCalibur LabLogic Laura LabWare LIMS Sciex Analyst PE Quantasmart PE FloOne TA Advantage Integrity Varian Cary Win UV Shimadzu IR Solution
9 Business objectives of SDMS E-data storage and archiving of all applications Vendor independent GLP compliant Readily archiving after finalization of study Unchangeable after archiving Human readable format Operational Accessible to study directors after archiving High level of automation Guaranteed implementation and maintenance support by vendor
10 SDMS selection Selected NuGenesis 7.1 by Waters in 2008 Upgrade to SR7 in 2012(Windows7 OS) Oracle database Current demand (2012): 500 Gb/year
11 Data storage in NuGenesis Fully automated storage (by Archive Agent ) vson demand (by Instrument Agent ) Two options to store data: File capture original data; original application needed to read and use data Print capture picture, like.pdf; human readable, usable for reporting (e.g. chromatograms), not for (re-)elaboration of data
12 1. NuGenesisand Empower Fully automated archiving at preset time interval and removal of original file after preset period of not being used
13 2. NuGenesisand Analyst Archiving after addition of trigger file to directory and immediate removal of original file
14 3. NuGenesisand Laura Archiving after transfer of file to pre-archive data directory and removal of original file after preset period of not being used
15 Archiving and deletion Application Archive after Delete after Empower 3 1 month after last modification 3 months afterlast modification Analyst On demand Immediate Laura 4 12h after transferto V:\Data 1h after file archived CaryWinUV 3.1 2d after file update 1 month after file archived Shimadzu IRsolution d after file update 1 month after file archived
16 Restoring of archived data files Read-only access in NuGenesis via Vision Webapplication (for users) Restore to accessible directory (V:\Data\restore) or directly to application database (e.g. Empower) by IT application manager Import by application If modified, new file is created and archived according to standard procedure
17 Quality Assurance Daily (only changes), weekly and annual (all) back-up on tapes Request for restore of archived data via management (written approval) Single point of control (IT application manager) All under audit trail
18 Audit trail
19 Challenges Annually ca. 2 new software applications: ongoing configuration Version control and updates in a validated environment Close collaboration between Operations / IT application manager / QA Transfer of responsibilities from IT towards archivist Going global
20 Résumé Valuable tool Can accomodate various applications from various vendors but needs tailor made solutions Proven added value in regulated (GLP) research environment Invest time and effort for implementation and validation Never finished...
21 Acknowledgements Mark van Bijsterveldt Erik Baltussen Paul Theeuwes Ruud van der Giessen (Waters)
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