Frequently Asked Questions (FAQ)

 
OnShore's services are application-neutral. Thus, we can validate any type of desktop application or enterprise technologies. We specialize in Enterprise Resource Planning (ERP), Enterprise Content Management (ECM), and Enterprise Compliance and Quality Management systems. We developed Accelerators for Microsoft Dynamics For Operations, Microsoft Dynamics AX, Microsoft Dynamics GP, Oracle e-Business, SAP, Oracle Fusion Cloud, Microsoft SharePoint, Veeva Vault, Cornerstone LMS, Matrix LMS just to name a few. We have validated many bespoke projects as well as commercial off the shelf software.
ValidationMaster is a comprehensive Enterprise Validation Management, Risk and Quality solution designed to provide a single source of truth for validation projects. The system uniquely is designed to support "Lean Validation" processes and thus is the only system to include a Validation Kanban Board to support visual, agile validation project management. The system includes a fully automated test engine that allows you to develop either fully automated test scripts or automatically capture and execute test scripts online. The system can be viewed on any Windows, Apple or Android device and is 21 CFR Part 11-compliant.
OnShore specializes in life sciences industry sectors including pharmaceutical, medical device, biotechnology, nutraceuticals, blood/tissue, vaccine, clinical, specialty pharmaceuticals, compound pharmacies, chemical, CMO/CRO's and government.
We offer 3 distinct service offerings: (1) ValidationCoach, (2) ValidationPro, and (3) ValidationOffice.
ValidationCoach℠ professional services are designed with a straightforward mission – to deliver just-in-time expert IV&V advisory services to coach you through the validation and verification of new, unfamiliar technologies using the latest best practices. ValidationCoach℠ is a very flexible service offering designed to meet the unique needs of each client. Our coaching services are delivered one-on-one to ensure maximum benefit and impact. For each coaching engagement, you have the flexibility to design your own unique coaching engagement.
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 ready-to-work team consists of a validation project manager, validation systems engineer and a validation test engineer at a minimum. Our 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 free up your internal resources to focus on other initiatives that impact your bottom line.
Our ValidationOffice℠ staffing service provides both domestic and global clients with the complete RightSourcing operational support on demand needed to achieve maximum efficiency. Our flexible staffing service is designed to meet your unique IV&V project requirements, from providing a single validation engineer to several validation team members with options for short or long term, temporary and contract-to-hire. With our IV&V staff on your premises, your teams can focus on strategy while we manage the overall process and ensure smooth transition to your production environment.

 

Validation sometimes has a reputation for being time-consuming and sometimes inefficient if driven by manual processes. In today's regulatory environments, many companies are seeking to do more with less. A Validation Accelerator delivers tools and resources to provide a starting point for the validation of commercial off the shelf (COTS) software.
Lean Validation is the process of eliminating waste and inefficiencies while driving greater software quality throughout the validation process. Lean Validation is facilitated through automation and validation best practices.
Yes! OnShore is a global Independent Validation and Verification (IV&V) firm. Our products and services have been helping clients across the globe to execute validation projects in a LEAN manner.
Yes! We are experts in cloud validation. We have conducted many exercises for various technologies. Specifically, we have validated systems in the Microsoft Azure environment as well as applications such as Salesforce.com configured for GMP processes. To support cloud implementations, we have developed Validation Accelerators to streamline cloud validation projects. Contact us for more information on our cloud services.
Yes! OnShore provides services to support system audits and software vendor audits. We provide audit check lists based on current best practices and provide detailed audit summary reports.
Yes! OnShore provides Learning and Competency management solutions that help life sciences companies track and manage training as well as deliver training resources on mobile devices as well as through desktops.
 

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