Business Approach to SDMS- utilization in a GLP Research ... · -UPLC-MSMS(Waters), GC-MS, GC and...
Transcript of Business Approach to SDMS- utilization in a GLP Research ... · -UPLC-MSMS(Waters), GC-MS, GC and...
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Business Approach to SDMS-
utilization in a GLP Research
Organization
Theo Noij
Head of Chemistry, WIL Research Europe
Associate Professor, AVANS Univ. Applied Sciences
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Understanding SDMS Understanding our business
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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
Biotechnics
Hillsborough (NC), USA
Midwest BioResearch
Skokie (IL), USA
WIL Research EU(NOTOX)
Den Bosch, NL
QS-Pharma
Boothwyn (PA), USA
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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
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Chemistry laboratories
Bioanalysis
- Pharmaceuticals/metabolites in blood and
tissues
- UPLC-MSMS (Sciex, Waters)
- Analyst, LabWare LIMS
- 12 staff
Environmental Fate
- Behiour of pharma and agro in environmental
systems; radiolabelled
- HPLC-RD, LSC, TLC, HPLC-MS, acc.mass MS
- Laura, Quantasmart, XCalibur
- 8 staff
Physical Chemistry
- PhysChem characteristics (Bp, visc, flamm,
Kow, sol, corr, expl, …)
- a.o. DSC, TGA, IR, UV; many others visual
observations and non-computerized
- TA Advantage, Shimadzu IR, Cary Win UV
- 4 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
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GLPGood 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
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Equipment4x Waters Acquity UPLC + Waters Xevo TQ-S MSMS2x Waters Acquity UPLC + Sciex API 5000 MSMS1x Waters Acquity UPLC + Sciex API 3000 MSMS1x Agilent 1200 + Sciex API 3000 MSMS1x 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-class8x Waters Alliance 2695
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Connectivity
TA Advantage Integrity
Thermo XCalibur
Varian Cary Win UV
PE Quantasmart
Shimadzu IR Solution
LabLogic Laura
LabWare LIMS
Sciex Analyst
Agilent GCMS Chemstation
Waters Empower
Agilent ICPMS Chemstation
….and many other
software applications
from other
research areas
(toxicology, QSAR’s,
statistics, …)
PE FloOne
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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
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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
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Data storage in NuGenesis
• Fully automated storage (by “Archive Agent”) vs on
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
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1. NuGenesis and Empower
Fully automated archiving at
preset time interval and
removal of original file after
preset period of not being used
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2. NuGenesis and Analyst
Archiving after addition of
“trigger” file to directory and
immediate removal of original
file
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3. NuGenesis and Laura
Archiving after transfer of file to
pre-archive data directory and
removal of original file after
preset period of not being used
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Archiving and deletion
Application Archive after Delete after
Empower 3 1 month after last
modification
3 months after last
modification
Analyst On demand Immediate
Laura 4 12h after transfer to
V:\Data
1h after file archived
CaryWinUV 3.1 2d after file update 1 month after file archived
Shimadzu IRsolution 1.10 2d after file update 1 month after file archived
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Restoring of archived data files
• Read-only access in NuGenesis via Vision Web-application (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
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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
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Audit trail
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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
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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 ....
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Acknowledgements
Mark van Bijsterveldt
Erik Baltussen
Paul Theeuwes
Ruud van der Giessen (Waters)