ValidationPro℠

Turnkey IV&V Services On Demand

We understand the business imperative to work smarter, not harder. Through ValidationPro℠, we deliver ready-to-work IV&V teams with the requisite practical hands-on knowledge and advanced test automation tools to optimize any type of validation project. Our team consists of a validation project manager, validation systems engineer and a validation test engineer.

The ValidationPro℠ team works closely with your implementation team to ensure a cohesive approach to your project. From beginning to end, we manage your validation project to enable your internal resources to focus on other initiatives that impact your bottom line.  Our ValidationPro℠ specialists come from the ranks of leading life sciences organizations. Each expert brings over a decade or more of enterprise validation experience to your project.


ValidationPro℠ professional services are delivered with a straightforward mission – to deliver a fully validated system leveraging a ready-to-work validation team. Our experts will coach your team on validation activities that establish and sustain validated environments while ensuring compliance.

 

Lean Validation: The OnShore Difference

Lean manufacturing is the systematic method for the elimination of waste ("Muda") within a manufacturing system. Lean manufacturing also takes into account waste created through overburden ("Muri") and waste created through unevenness in work loads ("Mura"). 

 

Based on the principles and concepts of lean manufacturing, OnShore defines lean validation as the delivery of independent validation and verification (IV&V) services with minimal waste, over work and structured consistent processes to ensure quality, efficiency and compliance. 

 

The pressure to achieve compliance while minimizing costs is a real concern for validation engineers.  For decades, validation engineers have struggled to apply regulatory guidelines coupled with industry best practices to achieve compliance.  However, many IV&V projects have included non-value added work (“muda”) and a lot of over- work/over-doing (“muri”) caused by changing standards and regulatory requirements.

 

Today’s advanced technology, especially cloud-based solutions and cybersecurity, call for a re-thinking of how we validate systems.  We endeavor with each project to minimize waste and eliminate much of the overwork that characterizes too many validation projects.  We leverage advanced tools and techniques to streamline validation efforts and ensure compliance.   Click here to read more about our lean validation strategies for enterprise and cloud-based solutions.

We Are Technology Neutral

Our expert validation team has deep experience in the validation of enterprise technologies.  We are neutral when it comes to the types of systems we have the ability to validate.  Our team has validated both Commerical-off-the-Shelf (COTS) and custom systems for clients.  We have successfully validated leading enterprise technologies including major Enterprise Resource Planning (ERP), Enterprise Content Management (ECM), Quality Management Systems (QMS), Laboratory Information Management Systems (LIMS), Electronic Batch Record (EBR) systems, Customer Relationship Management (CRM) systems, as well as many custom-developed systems.

 

 

We follow global regulatory guidelines and ISPE GAMP 5® methodologies in the delivery of our validation services.  We support validation in cloud, on-premise, and virtual systems environments.  ValidationPro is applicable regardless of your systems environment.  We bring automated testing and advanced requirements, performance, and qualification tools to help accelerate validation and manage validation deliverables in a consistent, compliant manner.

IV&V Automation is Here!

As an option to our ValidationPro℠ professional services program, we offer an innovative Enterprise Validation Management system known as ValidationMaster™. In addition to requirements management, test management, incident management and validation change control, ValidationMaster™ delivers automated validation testing to streamline the validation process.


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