Half-Day Complimentary Workshop
Thursday, November 24th , 2011
13:30 PM - 17:30 PM
Microsoft France
39 Quai President Roosevelt,
92130 Issy-les-Moulineaux, France
Tél : +33 1 57 75 10 00
Microsoft, NextDocs and Thermo Fisher Scientific invite you to a half-day workshop covering the hot topics of a fully integrated Laboratory Information Management System (LIMS), Document Management System (DMS) and enterprise environment - providing seamless communication between lab systems that contain data, documentation and reports with floor operations.
Whether you are looking for being able to stand up to an audit, you need compliant, secure and traceable data for your samples, specifications, SOPs, results, instruments, calibration records, training records, Certificate of Analysis, and much more. All of this information and documentation needs to be maintained in an integrated secure system which delivers a complete audit trail, eSignatures, and authentication,– on demand.
By attending you will:
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How to meet the increasing demands for regulatory compliance so that your organization can mitigate legal risks, improve corporate governance, and maintain the documentation that stands up to a regulatory audit
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How to improve business and operational effectiveness to adapt and meet changing regulations such as 21 CFR Part 11, EPA, FDA, SEC Rules, or ISO Certification
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How to reduce the amount of time spent on manually generating reports, retrieving paper documents and aggregating information required by regulators – and realize hidden cost savings.
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How to streamline and simplify reporting between your lab and enterprise systems
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How an integrated informatics solution simplified water, environmental and pharmaceutical regulatory compliance and transformed process efficiencies at Nova Biologicals : http://www.nextdocs.com/en-us/Case%20Studies/FINAL%20NOVA-CS.pdf
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How to maximize your informatics investments and better support critical management decisions
Session Agenda:
| Time |
Topic |
13:30 – 14:00 |
Registration |
14:00 – 14:15 |
Introduction
Microsoft Strategy to manage Industry Challenges.
(Philippe de Batz, Microsoft) |
14:15 – 14:30 |
Compliance without Complexity - 21CFR11 Compliant Document and Quality Management for Life Sciences (Orang Gholikhani, NextDocs)
- Company and Strategy Overview
- Document & Quality Management System
- Regulatory Submission, SOP, Clinical Trial
|
14:30 – 14:45 |
Informatics Division of Thermo Scientific and Enterprises ( Celine Crochet)
- Overview of LIMS and Laboratories needs
|
14:45 - 15:15 |
Why should a Document Management be integrated to a LIMS? (Christophe Benninghoff, NextDocs et Cristina Roman, Thermo)
- Nova Biological Case Study
Integration and its day to day benefits |
15:15 – 15:30 |
Coffee Break |
15:30 - 16:15 |
Demonstration of a Document Management System for Quality Document (SOP) within a regulated environment.
- Document Creation
- Optimizing Document diffusion
- Make user training easy
|
16:15 - 17:00 |
Demonstration of LIMS SampleManager. (Cristina Roman)
- Sample Management
- Features required by ISO17025
- User training
- Device Maintenance
- Store Management
|
17:00 - 17:30 |
QA |
Thursday, November 24th , 2011
13:30 PM - 17:30 PM
Microsoft France
39 Quai President Roosevelt,
92130 Issy-les-Moulineaux, France
Tél : +33 1 57 75 10 00
Register:
For more information, please contact: Orang Gholikhani orangg@nextdocs.com ou +33 601168839