ProLab, a unique and innovative module for project traceability and system validation

Transcription

1 1 ProLab, a unique and innovative module for project traceability and system validation Barcelona (Spain) April 04, 2017 Mohamed-J. Ndiaye CEO AGILAB / mjn@agilab.fr

2 2 Mohamed-Joachim Ndiaye Cofounder & 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

3 3 Overview AGILAB Who are we? SOLUTION QUESTION Can we make a paperless project traceability and system validation? ProLab module USE CASE LIVE DEMO A concrete example for a GxP laboratory Let s see how it works

4 AGILAB AGILAB Who we are and what we offer

5 5 AgiLab Push the limits of the lab 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

6 6 Our philosophy 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.

7 7 AgiLab Science platform Multiple standard features adaptables to laboratory needs 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

8 QUESTION Can we make a paperless project traceability and system validation?

9 9 What does validation mean? 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. This statement involves multiples steps with a time consuming and costly paper based process.

10 Validation process (V Model) 10 System validation must to be performed in laboratories where GxP applies (FDA: 21CFR part 11, GAMP) Specifications Traceability Qualifications User Requirements Specifications (URS) Performance Qualification (PQ) User Acceptance Testing Functional Specifications (FS) Operational Qualification (OQ) Unit Test Design Specification (DS) Installation Qualification (IQ) Build 10

11 11 What about traceability 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 This process requires hard work, high costs and can be plagued with errors and risks.

12 12 How can i transform my validation process

13 SOLUTION AgiLab Science ProLab module

14 History of the creation 14 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. 2 R&D centers in different cities > 100 laboratory users > 500 researchers LIMS Project team : 15 people How can we improve team collaboration, efficiency and traceability during specification and build in a paperless process?

15 15 ProLab for specifications and qualifications 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. The module helps our customer to improve collaboration and project traceability

16 USE CASE A concrete example for a GxP laboratory

17 17 Use case on instrument management 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 The use case will be executed on our AgiLab Science module for instrument management : Metrology

18 LIVE DEMO Let s see how it works

19 19 Thank you Paris Innovation Belleville - 24, rue de l Est Paris +33(1) contact@agilab.com