From Paper to a Paperless Data Management

Environment with iVention-iLES

Wageningen Bioveterinary Research(WBVR), 5e April 2017

Gerdina Kroes-Draaijer

Who we are.....Wageningen University

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Executive Board

Supervisory Board

Agrotechnology& Food

Sciences Group

Animal Sciences

Group

EnvironmentalSciences Group

Plant Sciences

Group

Food & BiobasedResearch

Agrotechnology& Food

Sciences

AnimalSciences

EnvironmentalSciences

PlantSciences

LivestockResearch

Wageningen Bioveterinary

Research

Wageningen Environmental

Research

Wageningen Economic Research

Wageningen Centre for

Development Innovation

SocialSciences

Wageningen Plant

Research

Social Sciences

Group

Concern Staff Facility Services

Who we are...WBVR

3

Director

Animal TechnologyStaff

Infection Biology Bacteriology &

Epidemiology

Diagnostics and

Crisis organization

Virology

What we do.........

Planning

Organization

Realization of animal experiments for the researchers of WBVR, Animal Science Group and external sponsors

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StudyplanCCD Authorization

Approval DEC/IvD

What we want......

1 system for all ‘products’ of Animal Technology

DPCCalculation

Scheduler Study book ARCHIVE

Software program/Cloud system

What was .......

Raw data on data capture forms

(Loose-leaf or bound in books)

Forms configured in Excel Microsoft Office

Paper registration accepted (GLP)

Supported by our document control system

Registration data on paper

Advantage Within AT accepted and everyone is familiar with the

forms. ‘Study-notebook’ was an understanding within WBVR Paper forms are tangible No Wifi and extra hardware needed in facilities

Registration data on paper

Disadvantage Not every manuscript is as readable Access is only possible on location (animal facility) Composing books means a lot of work and it is not

flexible. Extension of an experiment No back up of the data during the in life phase. Data will be retyped risk/errors! extra work!

User Requirement Specifications

Digitize Study-notebook

Software must be recognizable to the user!!

Enter data faster

Data easily accessible

Export data into Excel. Sponsor can do calculations directly

User Requirement Specifications

Reduce number of forms by use of picklists (specific for experiments)

Mandatory fields more standardized

Data entry validated

Audit module all changes are traceable

Web based system within WUR/WBVR environment

Cloud system continuous delivery

Achieved by.......

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To configure software that meets our requirements

Cloud system for fast update and continuous delivery

Empower end-user to configure forms by themselves

Within department AT a project team was composed

Project carried out in phases

1. Functional design

2. Configure framework and forms

3. Demonstrations to project team, testing system,

execute test plan

4. Installation of configured framework

5. Training project team and users (all)

6. Parallel registration (paper and digital)

(2013) Issues, bugs, adapt and

communicate changes

Project carried out in phases

7. Release (3.5) corresponding to URS freeze and

validate.

8. Validation in accordance with GAMP 5V model

9. 01-April-2014 ‘GO LIVE ‘ (R 3.5)

10.Release 4.2 October 2016 live (one day upgrade)

Validation.....with ITC Validation Consultants

Important deliverables

Validation plan

URS

Functional design

Traceability matrix

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Test protocols

SOP’s/trainings/manuals

Fit for use statement

Installation Verification

Operational Verification

Release notes

Foot and Mouth Disease (4)

Classical Swine Fever (3)

Respiratory Syncytial Virus (2)

Q-fever (3)

Psittacosis (3)

Rift Valley Fever (3)

Tuberculosis (3)

Avian Influenza (3)

Potential risk mitigation....

Found after/during validation:

User can fill in the wrong project when there are multiple experiments in 1 room

Researcher can also see into other projects

By server break down max 1 day data can be lost

Risks....that’s why

High availability backup (every 10 minutes)

ProcessStations (Release 4.2)

Experiences so far

Positive change

More standardized forms

Interim QC check more accessible without entering animal facilities

Researchers more involved ' read only ' function

Researchers are content with reports

All data exportable to Excel (Office integration)

more efficient

Every 10 minutes back-up of the database

(ftp server)

Satisfied ......?

No, never...

PROCESSSTATIONS

SCHEDULER(Q2 2017)

Facility planning

Personnel planning

Competences

Absence of the employees

ANIMAL EXPERIMENT QUOTATION SYSTEM

(Q3 2017)

And more....

Innovation

Measurements of equipment send directly into iLES.

For example: Balances

Bluetooth infrared thermometers (test phase)

Digital calipers

Our product.....

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Deliver raw data

Ad hoc report generation

Registered by the animal technicians in a highly configurable Cloud application

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Combined Animal and

Laboratory services

Facilitating your research

at all biosafety levels

Demonstration

iVention iLES/ELN

Release 4.2

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