Philippe Gaudreau

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  • Company Fact Sheet

    Market Description SOLABS addresses the needs of Life Sciences organizations such as Pharmaceutical, Medical Device and Biotechnology companies. SOLABS’ target is mid-size companies with local and/...

  • Infrastructure Requirements (On Premises)

    The document presents the SOLABS QM 10.X solution architecture. It also provides the hardware and software requirements to operate in accordance with SOLABS qualitystandards and performance expecta...

  • Pricing example - Cannabis Licensed Producer - 250-500 employees

    The Scope of this project includes SOLABS QM Essentials (Document Control & Audit Management), along with Training Management, Deviation Reporting and CAPAs.  Number of users : 40 Standard users an...

  • Data Migration FAQ

    Document Migration and Assistance from SOLABS?  SOLABS uses automated engines and heavily supports migration activities by providing a URS, assistance with writing verification protocols and test s...

  • Implementation Project Overview

    Overall Sequence of Activities  There are 6 to 8 main activities in the implementation project—depending on the SOLABS QM features selected by the client. No matter which features were selected, th...

  • Validation Approach for SOLABS QM 10

    There are four main categories requiring validation consideration for the SOLABS QM software. References:  SOLABS QM Validation Plan SOLABS QM Validation Package  

  • SOLABS QM Validation Plan

    Extract of SOLABS' provided Validation Plan:  Purpose Computer System Validation is a documented process for ensuring that GxP computerized systems are suitable for intended use and function accord...

  • SOLABS QM Validation Package

    A summary of validation deliverables are listed in the SOLABS QM Validation Documentation Index.  ...  Full details attached. 

  • New role, new EQMS system, what do I do?

    How it all started...  I’m the new QA Director & I’m the system owner of our new eQMS The implementation project is very far along...  Also, this is my first time owning a system Not only that, we...

  • Client Specific Deliverables

    Here is a good starting point for deliverables generally created by clients during implementation projects, which ensures a good transition towards operating SOLABS QM successfully!  Spreadsheet fo...