Our core competency is independent validation and verification (IV&V). We are validation experts. We serve government, life sciences and private sector companies in the validation of enterprise technologies. We also support site, equipment, and process validation as well.
OnShore primarily serves the life sciences industry including pharmaceutical, medical device, biotechnology, nutraceutical, healthcare and other such companies. We also support government agencies where IV&V is a critical process for government systems. OnShore supports other industries as well including Tobacco, chemical, high technology and others.
ValidationMaster™ is the FIRST comprehensive Enterprise Validation Management solution (EVMS) designed by validation engineers FOR validation engineers. The system includes rich capabilities including requirements management, automated test script development and execution, incident management, enterprise content management and much more. ValidationMaster™ is accessible via mobile, tablet or desktop and is designed to seamlessly manage the full validation process and help maintain the validated state. Sign up for our weekly demo to learn more about its capabilities.
Typically, validation exercises require multiple software applications to successfully complete the project. A project management tool is used along with automated test tools, incident management software, requirements management software, content management systems, risk management, test execution software and many other applications. Further, many validation engineers use digital or electronic signature technologies to facilitate the electronic route, review and approval of validation documentation. The use of multiple disparate, non-integrated technologies slows down the process and drives inefficiencies in the process. ValidationMaster™ helps to eliminate efficiencies and improve compliance through a seamlessly integrated system designed to work the way you work.
ValidationMaster™ can manage multiple validation projects simultaneously. Through its innovative dashboard, validation managers can see at a glance, the status of each project and understand where the bottlenecks are. ValidationMaster™ represents a single source of truth throughout the project allowing validation engineers to create, route, review, approve and view validation deliverables throughout the project lifecycle. The system tracks requirements and their associated test scripts creating seamless traceability backwards and forwards. ValidationMaster was designed with compliance in mind. The system includes built-in capabilities to support ISPE GAMP 5® and other related methodologies. Streamlining the validation process is all about eliminating inefficiencies. ValidationMaster™ includes fully automated testing, traceability and helps validation engineers with automation of the most time-consuming part of validation which is test script development.
YES. ValidationMaster™ was designed with ISPE GAMP 5® in mind. The system includes features such as test step labeling to ensure that proving steps, navigational steps, and other steps are clearly identified. The system supports a comprehensive risk assessment process as is recommended by ISPE GAMP 5®. There are many other features too numerous to name. Check out our weekly demo to learn more about its capabilities.
YES, many of our validation exercises are conducted in a cloud environment. All cloud providers are not created equal. OnShore strongly recommends a comprehensive supplier assessment to ensure that cloud providers have the requisite quality processes and procedures in place to support validation. Cloud environments can be validated. Contact OnShore today for more details on how to ensure that your application is properly validated in the cloud.
OnShore Technology Group is application NEUTRAL. WE CAN VALIDATE ANY TECHNOLOGY. However, we have unique experience with ERP systems such as Microsoft Dynamics AX, Microsoft NAV, Microsoft GP, BatchMaster Electronic Batch Records system, SAP, Infor, and many others. We also have experience with Microsoft SharePoint, EMC/Documentum, Bovia Qumas eDocCompliance, Merit Solutions MaxLIFE™ ECM, and many others. The principles of validation endure regardless of technology. OnShore has deep experience in the IV&V of enterprise technologies. Contact us today to learn more about our validation capabilities.
YES, OnShore offers custom training services to support Validationmaster and to assist companies in understanding computer systems validation. Through our ValidationMaster Academy, we offer online learning as well. Contact us today to learn more about our training services and how we can help.
ValidationMaster™ is sold as either an on-premise or hosted application. It is sold on a subscription basis. Contact our sales team for more information on pricing and our delivery models. When ValidationMaster™ is sold, we also offer validation test scripts and documentation to support the validation of ValidationMaster™ itself.
YES, OnShore does provide services designed to assist companies with the development of SOPs. We often find in smaller companies that they do not have the requisite SOPs to support the validation process. We strongly believe that validation must be conducted based on your unique SOPs. If you do not have a set of SOPs to provide governance of your validation processes, OnShore can assist you with the development of SOPs that will support your team. Contact us today for more information on this important service offering.
YES, OnShore does conduct independent audits to help companies assess their level of compliance. Our audit services are conducted in the strictest confidence and we deliver detailed, actionable audit reports to help you understand any deficiencies or anomalies uncovered during the audit. Contact us today for more information on this important service offering.
YES! OnShore provides services across the U.S., Canada, Europe, Japan and the rest of the world. We are a global company. Our team understands global regulatory requirements with respect to validation. ValidationMaster™ is internationalized and offered in over 64 different languages out of the box.
ValidationCoach™ is a flexible, unique service offering designed to assist experienced validation engineers with the validation of enterprise technologies as needed. Sometimes, experienced validation engineers require assistance with the validation of new technologies they may not be familiar with or they may require updated training or may be shorthanded and require the assistance of an experienced team. ValidationCoach™ is the answer. ValidationCoach™ is designed as a coaching and mentoring service for experienced validation engineers. Each assigned coach has decades of validation experience to help you achieve your unique project goals. Contact us today to speak with one of our experienced coaches.
ValidationPro™ is a full-service, turnkey offering designed to deliver a fully validated system. We bring an experienced validation team to each project. From project management through test script execution and summary, our team develops and delivers all validation documentation in a manner consistent with current regulatory guidelines and the latest validation methodologies. ValidationPro™ is our most popular service offering designed to help companies achieve compliance and ensure validation of enterprise technologies. We stand ready to assist with ERP, MRP, Quality Management, Content Management and other related technologies. Contact us today to learn more about our professional IV&V service offerings.
We support both "hands on" and "hands off" test automation. Our hands on test automation allows validation engineers to fully execute validation test scripts online by clicking through the steps of each test script. Our hands off validation test automation allows validation engineers to determine the number of scripts to be tested and the specific time of day of the testing. ValidationMaster's Testmaster™ module is designed to execute all test scripts with NO HUMAN INTERVENTION. This is excellent for regression testing or unit testing processes.
OnShore supports leading validation methodologies including ISPE GAMP 5, FDA, EU Annex 11 and other related validation methodologies.