19
www.agilab.com ProLab, a unique and innovative module for project traceability and system validation Barcelona (Spain) – April 04, 2017 1 Mohamed-J. Ndiaye CEO AGILAB / [email protected]
www.agilab.com
ProLab, a unique and innovative module for project traceability and system validation
Barcelona (Spain) – April 04, 2017
1
Mohamed-J. Ndiaye
CEO AGILAB / [email protected]
www.agilab.com
Mohamed-Joachim NdiayeCofounder & CEO AGILAB
About Mohamed
Lab Informatics expert
LIMS Project manager for several years in forensic, pharmaceuticals,
fine chemicals and environment.
Biologist by training, I hold a Masters in Bioinformatics, a second
Masters degree in management of innovative projects and some
good skills also in martial arts and italian food cooking
2
www.agilab.com
AGILAB
Who are we ?
QUESTION
Can we make a paperless project
traceability and system validation ?SOLUTION
ProLab module
USE CASE
A concrete example for a GxP
laboratory LIVE DEMO
Let’s see how it works
Overview3
www.agilab.com
AGILAB
AGILAB
Who we are and what we offer
www.agilab.com
Key facts
• Created in 2010
• Headquarter in Paris (France)
• Team of experienced consultants
• Unique LIMS & ELN Platform : AgiLab Science
• Agile approach in lab project delivery
• Customer success in GxP labs across industries :
• Petrochemical, Anti-doping, Environment, Food and beverage…
AgiLab – Push the limits of the lab5
www.agilab.com
Recent and robust technology
Provide a unique platform with innovative functionalities to meet the
lab requirements
Agile approach
Adopt an agile approach for better collaboration, improved traceability
and needs collection
LIMS & ELN Platform
The AgiLab Science platform is a new generation of applications for laboratories,
providing solutions that are not only built using the most recent technology and
architecture but also with adaptability, security and agility.
ProLab Module
A project and validation management module from AgiLab Science platform to
enable a 100% paperless and automated process from specifications to validation.
Our philosophy6
www.agilab.com
Multiple standard features adaptables to laboratory needs
7
AgiLab Science platform
Business applications
• AGILIMS PRD : Production control
• AGILIMS INT: Internal testing
• AGILIMS SRV : Contract Labs
• MICROLAB : Microbiology & Environment Monitoring
• FORMULAB : Formulation
• CHEMLAB : Research in chemistry
• BIOLAB : Research in biology
Common modules
• ADMIN : Security administration
• REFERENCE : Master data management
Integrated or standalone modules
• ACTIVITY : Resource management
• ANALYTICS : Advanced data analytics
• MATERIAL : Reagent management
• METROLOGY : Instrument management
• QUALITY : Quality management
• STABILITY : Stability & aging studies management
AGILAB SCIENCE
www.agilab.com
QUESTION
Can we make a paperless project
traceability and system validation ?
www.agilab.com
Statement
Validation of an electronic system is to show and
demonstrate that a system is exactly doing what it
should do in an installed environment under any
circumstances.
What does validation mean ?
This statement involves multiples steps with a time consuming and costly paper based process.
9
www.agilab.com10
Validation process (V Model)
System validation must to be performed in laboratories where GxP applies (FDA: 21CFR part 11, GAMP)
Traceability
Build
User Requirements Specifications (URS)
Functional Specifications (FS)
Design Specification (DS)
Performance Qualification (PQ)
Operational Qualification (OQ)
Installation Qualification (IQ)
Unit Test
User Acceptance Testing
Specifications Qualifications
10
www.agilab.com
Traceability “loves” paper and files
• MS Excel/Word files for URS, FS and DS
• Internal application or Excel sheet for test feedback
during build process
• MS Excel/Word files for IQ, OP, PQ definition
• Paper signed document for UT
• Traceability Matrix
• Risk assessments
What about traceability
This process requires hard work, high costs and can be plagued with errors and risks.
11
www.agilab.com
How can i transform my validation process12
www.agilab.com
SOLUTION
AgiLab Science ProLab module
www.agilab.com
History of the creation
How can we improve team collaboration, efficiency and traceability
during specification and build in a paperless process ?
• 2 R&D centers in different cities• > 100 laboratory users• > 500 researchers• LIMS Project team : 15 people
The French Institute of Petroleum (in French: Institut français du pétrole, IFP) is s a public-sector
research, innovation and training center active in the fields of energy, transport and the environment.
14
www.agilab.com
Integrated module
• First version : specifications• Tracking and centralization in the application of the
specifications (URS, FDS, DS), test feedback
• Second version : extension to qualifications• definition and execution.
ProLab for specifications and qualifications
The module helps our customer to improve collaboration and project traceability
15
www.agilab.com
USE CASE
A concrete example for a GxP laboratory
www.agilab.com
The use case will be executed on our AgiLab Science module for instrument management :
Metrology
Change status on an instrument
• Review of the FDS defined for the user
requirement : instrument change status
• Creation of the test script from the FDS
• Execution of the test script
• Approval
Use case on instrument management17
www.agilab.com
LIVE DEMO
Let’s see how it works
www.agilab.com
Thank you
Paris Innovation Belleville - 24, rue de l’Est - 75020 Paris
+33(1) 1.83.64.42.48
19
www.agilab.com
