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Driving IV&V Efficiency and Sustained Compliance

As enterprise technology is introduced within life sciences companies, the need for speed, efficiency and compliance abounds.  OnShore Technology Group has a legacy of the development of "Validation Toolkits" that were originally designed to jump start the validation process.  We developed toolkits for Microsoft Dynamics AX/NAV/GP and many other solutions.  These toolkits were primarily document based and for manually-driven validation processes offered clear value.  However, the processes were still MANUALLY-DRIVEN.

In today's regulated systems environment, life sciences companies are adopting technologies at an accelerated pace.  Business imperatives and market forces are demanding the rapid adoption of systems such as ERP, quality management, content management, IoT, mobile technologies and many more.  The principles of validation yet endure.  These technologies STILL must be validated in accordance with their intended use and in compliance with global regulatory requirements. 

The challenge for many is how to achieve sustained compliance while driving validation operational efficiencies and greater productivity.  The Validation Accelerators do just that.  They accelerate validation by eliminating manual, costly, time-consuming validation processes and delivering automation at its core.  Our award-winning flagship application ValidationMaster™ is coupled with a comprehensive set of out-of-the-box user requirements and test scripts for Commerical-of-the-Shelf (COTS) enterprise applications.

 

WE OFFER VALIDATION ACCELERATORS FOR LEADING TECHNOLOGIES AS HIGHLIGHTED BELOW

 

Microsoft Dynamics 365®

BatchMaster GP

SAP® ERP System

BatchMaster NAV

Oracle e-Business®

Microsoft SharePoint®

Fullscope EDGE

Merit Solutions MaxLIFE

Veeva ECM®

M-Files®

Oracle Fusion®

ValidationMaster EVMS

 

 

DO YOU NEED TO VALIDATE MICROSOFT DYNAMICS 365 OR OTHER ENTERPRISE TECHNOLOGIES?

Contact us today to learn how our accelerators can jumpstart your next project saving time and money.

Automation Delivered

At the heart of our Validation Accelerators is ValidationMaster™ - a full-featured Enterprise Validation Lifecycle Management solution designed to deliver the tools you need to conduct the full validation lifecycle for new enterprise technologies adopted by your company.

 
 

Ready-to-Use

Each Validation Accelerator comes with ready-to-use requirements traced to test scripts to allow you to conduct IV&V activities right away using the system.  Our team assists you with getting the system up and running quickly.

Single Source of Truth For Validation

With ValidationMaster™, you have a single source of truth for all of your validation projects.  In addition to the initial system you validate, ValidationMaster can be used for all types of validation projects.

 

Reusable Test Script & Requirements Library

Validation test script development and execution is central to all validation projects.  Our experienced validation professionals can assist with the development of test scripts in accordance with global regulations using our advanced automated tool.

Unique Document/Report Formats

For each engagement, OnShore shall establish an online validation portal to facilitate collaboration throughout the project.  A validation rolling schedule, task list, risk register and incident list is included.

 
 

Regulatory Compliance

At the conclusion of each project, OnShore will archive all validation deliverables to DVD to support potential audit activity.  All signed/ approved/ effective documentation and supporting info will be archived.