Business Approach to SDMS-

utilization in a GLP Research

Organization

Theo Noij

Head of Chemistry, WIL Research Europe

Associate Professor, AVANS Univ. Applied Sciences

Understanding SDMS Understanding our business

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

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

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

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

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

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

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

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

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

1. NuGenesis and Empower

Fully automated archiving at

preset time interval and

removal of original file after

preset period of not being used

2. NuGenesis and Analyst

Archiving after addition of

“trigger” file to directory and

immediate removal of original

file

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

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

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

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

Audit trail

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

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 ....

Acknowledgements

Mark van Bijsterveldt

Erik Baltussen

Paul Theeuwes

Ruud van der Giessen (Waters)