Lean Independent Validation & Verification Services

 

Validation is a mission-critical process within the life sciences industry, chemical, engineering as well as government agencies.  The IEEE 1012 Validation and Verification Standard strongly recommends three levels of independence with conducting validation exercises: (1) Technical Independence, (2) Financial Independence and (3) Managerial Independence.  Validation should be conducted by those not close to the development environment to ensure objectivity and compliance.

WE PRACTICE LEAN VALIDATION.   OnShore Technology Group, the developers of ValidationMaster, is an IV&V firm dedicated to the development and delivery of validation services to help companies validated computer systems, processes, equipment and other validation exerices.  We specialize in cloud computer systems validation and ERP systems validation.  We are the authors of the FDA Validation Toolkit for Microsoft Dynamics AX, Microsoft Dynamics 365, Microsoft NAV, and Microsoft GP.  Our services are designed to develop validation deliverables by eliminating wasteful, non-value added while optimizing the validation process.

 

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NEED ASSISTANCE WITH THE VALIDATION OF MICROSOFT DYNAMICS 365, ORACLE E-BUSINESS OR SAP?

Contact us today to learn more how our lean validation services accelerate validation and can help you succeed with your next project.


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ValidationPro Professional Services

 

Ready-to-Work IV&V Team

Through ValidationPro℠, we deliver ready-to-work IV&V teams with the requisite practical knowledge and automation tools to optimize any type of validation project.  Our team works closely with your implementation team to ensure a cohesive approach to your project and frees up your internal resources to focus on other initiatives

Validation Project Management

For each ValidationPro we take charge of the validation process and manage it from end to end. We complete ALL validation deliverables on your behalf while freeing up your internal team for other mission-critical tasks

ValidationPro Custom Workshop

For each ValidationPro℠ engagement, we start each engagement a customized validation workshop to ensure that we understand your processes and procedures and establish common ground at the beginning of the project.

Test Script Development & Execution

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 tools.

Validation Project Portal

For each ValidationPro℠ 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.

Archival of Validation Deliverables

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.

ValidationCoach℠ Professional Services

 

Validation Coaching & Mentoring

We offer expert, flexible coaching and mentoring for experienced validation engineers to help validate new systems, develop enhanced strategies and other IV&V activities.  ValidationCoach is intended to support experienced validation engineers.

ValidationCoach Master Class

Our ValidationCoach Master Class℠ training provides comprehensive, in-depth training on validation principles and best practices for process, equipment, computer systems validation and site validation programs

ValidationCoach Custom Workshop

For each ValidationCoach℠ engagement, we offer a customized validation workshop to help establish common ground and plan each coaching engagement to ensure success. 

Validation Testing Services

As an experienced Validation Coach, we can assist with tactical IV&V activities.  Using our advanced automated testing tools, we can assist with the development and execution of validation test scripts including IQ/OQ/PQ and User Acceptance Testing (UAT).

Project Management Services

Through our coaching services we deliver comprehensive IV&V project management services driving your validation projects to a one-time successful conclusion. 

SOP Development Services

Standard Operating Procedures (SOPs) are essential for validation.  Without SOPs, one cannot conduct validation activities.  Through ValidationCoach, we provide expert guidance in developing SOPs.

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Accelerate Your ROI

One of the key benefits of CloudMaster 365™ is the excellent return on investment of the solution.  CloudMaster 365™ is delivered with a full, comprehensive Enterprise Validation Lifecycle Management and Quality system known as ValidationMaster™.  Beyond the initial validation exercise, CloudMaster 365™ pays dividends well beyond the initial validation exercise.  Many companies have seen a 100% return on investment with the first project.  CHECK OUT OUR ROI CALCULATOR

Learn More

We invite you to access our Download Center and read more about our Validation Accelerators.  Our download center includes case studies, marketing collaterals and data sheets, white papers and much more.  Read our blog branded as The Validation Post for more detailed indepth strategies, best practices and thought leadership on lean validation strategies, Validation Accelerators and the latest innovations for validation project management.

Innovation In Action

Life sciences companies across the globe are seeing the benefits of our CloudMaster 365™ Validation Accelerators.  Instead of getting a stack of documents from a vendor, CloudMaster 365 provides you with the system, the documentation, the testing, and the processes to help deliver validation.  Our clients have added their own due diligence to ensure compliance with current regulatory guidelines. 

Mastering Regulatory Compliance

CloudMaster 365 is compliant with current global regulatory guidelines.  The ValidationMaster Enterprise Validation Lifecycle Management system includes compliance with 21 CFR Part 11, change control, regulatory content management, incident management, CAPA, nonconformances, training and other regulatory processes.  The system is designed to work together in a cohesive manner to deliver maximum value for lean validation processes.