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Polysciences Selects Onshore Technology Group For IV&V
April 15, 2016
Chicago, Illinois - FOR IMMEDIATE RELEASE. OnShore Technology Group, leading global provider of Enterprise Validation Management (EVM) solutions and services, has been engaged to deliver Independent Validation & Verification (IV&V) services for Polysciences to support the implementation of its new BatchMaster™/SAP BusinessOne® ERP system. For FDA regulated companies, IV&V is a mandatory process designed to ensure that enterprise software applications used highly regulated manufacturing and quality processes perform according to their intended use and have the ability to process information in a consistent, repeatable manner.
“With the continual need for innovation in medical technology, our business is growing at a rapid pace,” said Tom Foster, Director of Supply Chain and ERP Transformation at Polysciences. “In our selection of an IV&V partner, we were looking for an innovative company that had deep enterprise computer systems validation experience and leveraged advanced technology in the delivery of their services. After a comprehensive review of IV&V vendors, we were very impressed with OnShore’s ValidationMaster™ solution and their lean validation 360° services approach”, Tom Foster continued.
As Polysciences makes progressive advancements in medical technology designed to improve the quality of life for many, the company seeks to become the partner of choice for its clientele by providing essential components for their innovative products. Polysciences is poised to take on lager scale commercial manufacturing for medical technology companies. As the company moves forward with these initiatives, OnShore Technology Group will play a key role in helping the company drive software quality across the enterprise and validate the newly selected ERP system in accordance with current regulatory guidelines. “Polysciences and our customers operate in a highly regulated environment. A fully validated ERP system ensures our customers’ confidence in Polysciences’ processes and controls. We are also integrating Quality Management System into ERP to provide quality performance transparency and drive for continuous improvement”, said Thai Nguyen, Polysciences Director of Quality Assurance and Regulatory Affairs.
Valarie King-Bailey Tapped As Keynote Speaker at 2016 Microsoft Industry Summit
February 1, 2016
Chicago, Illinois - FOR IMMEDIATE RELEASE. Microsoft Corporation, world's leader in enterprise and desktop software has tapped OnShore's CEO Valarie King-Bailey as one of the keynote speakers for the 2016 Microsoft Industry Summit to be held at The Terranea Resort in Rancho Palos Verdes, California. The focus of the industry summit is to bring together thought leaders in the finance, manufacturing, public, retail, services, wholesale distribution, and CPG industry sectors.
In keeping with OnShore's focus on independent validation and verification, Valarie's keynote entitled "Independent Validation & Verification of Azure: A Practical Approach" will focus on the challenges of conducting computer systems validation in the cloud. As life sciences companies grapple with the many complexities of cloud validation, Valarie will be discussing how the cloud changes the paradigm of validation in this unique type of environment. "The principles of validation endure but the cloud changes how we look at validation", says Valarie King-Bailey, CEO of OnShore Technology Group. "Given the changing roles and responsibilities brought about by cloud environments, companies must re-think their validation strategies and update SOPs to ensure compliance", she continued.
OnShore Technology Group offers ValidationMaster™, the first Enterprise Validation Management and Quality system to support validation exercises in the cloud. ValidationMaster includes requirements management, incident management, risk management, project management and automated testing features to support validation in cloud environments. The system also includes an integrated portal known as the ValidationMaster™ Portal that includes a 21 CFR Part 11-compliant document management system as well as many other features.
OnShore Technology Group Sponsors 2016 IVT Computer Systems Validation Event
February 15, 2016
Chicago, Illinois - FOR IMMEDIATE RELEASE. Onshore Technology Group today announced its participation in the 2016 Annual Computer Systems Validation Conference sponsored by the Institute of Validation Technology. Each year IVT holds its annual conference in Philadelphia to highlight new challenges, strategies, and techniques for computer systems validation and features some of the worlds most renowned speakers on the topic of computer systems validation. Onshore is hosting this year's conference as the hospitality sponsor. Through this sponsorship, Onshore Technology Group's CEO will be giving a keynote address and hosting participants in one-on-one sessions that highlight Onshore's products and services and allow prospects to discuss their unique validation challenges with Onshore validation experts.
We are excited to be given the opportunity again this year to be the hospitality sponsor of the Institute of Validation Technology Computer Systems Validation Conference said Valarie King Bailey, CEO of Onshore Technology Group. "Last year we had overwhelming attendance and I received the honor of Speaker of the Year for 2015", continued Valarie.
At this year's conference, Onshore Technology Group will be showcasing its Enterprise Validation Management System, ValidationMaster™. This year's conference will be held at the Hilton at Penn's Landing in Philadelphia, PA on April 26-28, 2016. This is in the industries must-attend event for computer systems validation professionals who are responsible for implementing and maintaining a best in class program within their companies.
OnShore Technology Group Launches New Website
February 22, 2016
Chicago, Illinois - FOR IMMEDIATE RELEASE.
OnShore Technology Group is pleased to announce the launch of our newly designed website. The website’s homepage features a newly designed banner that highlights the company as Chicago’s independent validation and verification center of excellence. The new site also features an uncluttered design as well as newly design content focusing on our comprehensive portfolio of validation products and services. Our goal was to make the new website faster, easier to navigate, and more user-friendly for website visitors.
As a leader in independent validation and verification, it is important for us to provide rich content and information regarding our professional services and solutions easily accessible for current and prospective clients. We endeavor to provide our clients with the most accurate, up-to-date information and share our knowledge and expertise in the field of IV &V.
Our newly designed website features and all new updated downloads section where past webinars, seminars, white papers, and other resources can be viewed by registered participants. We have added to our download section a validation template section. Many times we are asked to provide templates for the various validation document deliverables to be produced during computer systems validation exercises. We provide these templates and other resources free of charge to assist the validation community at large with their validation efforts.
We also wanted to give prospects and clients an opportunity to get to know us better, who we are as a company, and the leaders driving the OnShore Technology Group team. By browsing the About Us section you’ll get a pretty good idea of who we are, what we do, and the team behind our success.
One of the most noticeable changes to our website is a new social media section. We are stimulating conversation and asking visitors and our clients to join our social media community. We are also launching the first inaugural edition of the validation post, a blog highlighting validation innovation, strategies, and best practices.
We also have an all new events page that allows visitors to understand the current events that we will participate in with links to register for our weekly validation demo sessions. Online registration is easy and allows visitors to register for either one of our Tuesday or Thursday free demonstrations.
In addition to informing our customers, the goal of the new website is to become a central repository for content, best practices, and information concerning validation. We provide white papers, presentations, and other resources to contribute to the thought leadership in the computer systems validation world. We pride ourselves on being a thought leader in the IV &V field and look forward to hearing any feedback from you on our new website.
OnShore Technology Group Launches New Blog “The Validation Post”
OnShore Technology Group is pleased to announce the launch of our new blog called “The Validation Post”. For some time now we have been eager to redesign our website and provide a blog that would give our visitors new resources and content related to independent validation and verification (IV&V) topics. The Validation Post blog will feature thought-provoking discussion on topics including automated testing, validation planning, cloud validation, cyber security validation, validation of mobile applications, validation regulatory considerations, and much more. You will be able to view profiles for our blog authors and you will be able to browse post by topic or by author.
“The Validation Post is a must read for anybody involved in the field of independent validation and verification” said Valarie King Bailey, CEO of OnShore Technology Group. “We intend for the validation post to become a daily read for validation engineers and senior managers responsible for independent validation and verification”, she continued.
The Validation Post will feature specific content of interest to our validation community. Readers will learn the latest best practices and will find the latest information on what’s happening in the validation community. We are very excited about The Validation Post and look forward to which launch and providing rich content to our loyal validation community.
OnShore CEO Wins Coveted IVT “Speaker of the Year” Award
October 27, 2015
Chicago, Illinois - FOR IMMEDIATE RELEASE.
On October 27, 2015 Valarie King Bailey, CEO of OnShore Technology Group received the industry award presenter of the year from the Institute of validation technology, the leading global publisher and conference provider for validation and compliance. The award was presented by John Kirshner, Dir. of conference division, for IVT and the historical rose garden ballroom of the Hyatt hotel in Philadelphia. Throughout 2015, Valarie presented several keynote presentations that were the highest rated presentations of the year in the North America conference.
In 2015, Valarie spoke on timely topics including green validation and validation cyber security challenges which were highly rated by conference attendees. Valarie sessions were standing room only in each case. She delivered topics on validation risk assessment and paperless automated validation strategies for the 21st century. The competition for this award included over 200 presenters from the pharmaceutical industry, industry task forces, and from the US FDA.
Valarie is one of our most dynamic speakers said John Kirshner, conference director of IVT. “Her presentations are thought-provoking and engaging which are audiences find refreshing given a topic that does not typically provoke excitement. Valarie’s presentations are game changers in the field of validation. We are happy to have her as a keynote speaker, he continued.
IVT is dedicated to validation and compliance for FDA and other global regulatory agencies related to the life sciences industry. The organization publishes journals and books and organizes highly professional conferences around the world. Over 90% of conference attendees come from pharmaceutical and medical device industries. IVT sponsors validation week and an annual computer systems validation conference each year in the United States and Europe.
ValidationMaster™ Recognized as one of the 2015 CIO Top 20 Solutions For Pharma
March 31, 2015
Annual list showcases the 20 Most Promising Pharma and Life Science Technology Solution Providers 2015. OnShore Technology Group makes it to CIO Review’s top Pharma and Life Science Solution Providers list for providing quality IT services across the entire gamut of the pharmaceutical value chain.
FREMONT, CA—March 31, 2015 —CIO Review (www.cioreview.com) has chosen OnShore Technology Group (www.OnShore Technology Grouptech.com) for its 20 Most Promising Pharma and Life Science Technology Solution Providers 2015. The positioning is based on OnShore Technology Group’s Independent Validation and Verification (IV&V) professional services and solutions designed for Pharmaceutical and Life Sciences companies.
The annual list of companies is selected by a panel of experts and members of CIO Review’s editorial board to recognize and promote technology entrepreneurship. “OnShore Technology Group has been on our radar for some time now for stirring a revolution in the pharma and life science space, and we are happy to showcase them this year due to their continuing excellence in delivering top-notch pharmaceutical solutions,” said Harvi Sachar, Publisher and Founder, CIO Review. “OnShore Technology Group’s solutions continued to break new ground within the past year benefiting its customers around the globe, and we’re excited to have them featured on our top companies list.”
“OnShore Technology Group is honored to be recognized by CIO Review’s panel of experts and thought leaders,” said – Valarie King-Bailey, CEO, OnShore Technology Group.
About CIO Review
CIO Review constantly endeavors to identify "The Best" in a variety of areas important to tech business. Through nominations and consultations with industry leaders, our editors choose the best in different domains. Pharma and Life Science Technology Solution Providers Special edition is an annual listing of 20 Most Promising Pharma and Life Science Technology Solution Providers in the U.S.
Valarie King-Bailey Delivers Keynote at Pullman Scholars 2nd Annual Symposium
May 21, 2015
OnShore Technology Group each year endeavors to inspire our youth. Valarie King Bailey, CEO of OnShore Technology Group is a tireless advocate for STEM (Science/Technology/Engineering/Math) education among youth. The George M Pullman Educational Foundation tapped Valarie as the keynote speaker for the second annual Pullman Scholarship Symposium on May 21, 2015.
More than 200 current and former Pullman scholars attended the event Pullman scholars attended an afternoon of sessions on topics such as business meal etiquette, handling student loans, financial literacy, life mapping, building a personal brand and handling stress. After these interactive sessions, current scholars were joined by nearly 100 Pullman scholar alumni for networking. In the evening, Valarie delivered the keynote address providing thought-provoking words of wisdom and encouragement to the attendees. The event marked the 65th anniversary of the Foundation.
The George M Pullman Educational Foundation supports the dreams and aspirations of outstanding graduating high school students with merit-based and need-based scholarships and continuing educational support as they pursue their bachelors degrees at a college or university of their choice. Endowed by the estate of industrialists visionary George Pullman, the George M Pullman educational foundation has been keeping the dream of education on track for Chicago area students since 1950.
Valarie was a recipient of the George M Pullman educational scholarship in 1976. This scholarship helped Valarie attend the University of Wisconsin – Madison and pursue her goal of becoming a civil and environmental engineer. Valarie graduated from the University of Wisconsin in 1982 and was awarded the Distinguished Alumni Award in 2008 from the University of Wisconsin College Of Engineering. In 2010, Valarie was awarded a Lifetime Achievement Award from the UW Construction Club – College of Engineering.
“It is so important to me to help inspire today’s youth to continue to pursue their education. It is an honor and a privilege to speak to young people regarding the merits of staying in school and going for their dreams”, said Valarie King Bailey, CEO of OnShore Technology Group. “The Pullman foundation scholarship meant so much to me as a young person in helping me to pursue my dreams. It was an honor to speak at this event where they honored the best of the best in the Chicagoland area. All honor is due to all the tireless workers at the George M. Pullman educational foundation for the fantastic work that they have done since 1950. I continue to wish all current and future Pullman foundation scholars the very best in their future endeavors. I wish God speed to the George M Pullman foundation.”, she continued.
You can watch the 2015 symposium speech by Valarie in its entirety right here.
OnShore Announces ValidationMaster 2015™ Enterprise Validation Management System
January 1, 2015
OnShore Technology Group, global leader in IV&V quality and compliance solutions today announced the release of ValidationMaster 2015™ enterprise validation management and quality system. ValidationMaster 2015™ is an integrated IV&V and quality management solution designed to manage the full lifecycle of validation projects across the enterprise. Designed to support paperless and automated validation processes, validation master includes an automation test engine designed to streamline the creation and execution of validation test scripts. The system includes modules to support requirements management, incident management, risk assessment and management, validation content management, audit management, automated testing and execution, and many other rich features to support the validation process.
“For over 40 years, validation has been conducted as a very manual, paper-based process. ValidationMaster 2015™ represents the next generation in validation management systems. It is a total solution designed for and by validation engineers to support lean validation processes” said Valarie King Bailey CEO of onshore technology group. “With the ValidationMaster 2015™ our clients are seeing as much as a 60% reduction in the time it takes to create validation test scripts for their projects”, she continued.
ValidationMaster 2015™ was designed to work the way validation engineers work. It is understood that validation engineers deploy multiple tools in the pursuit of validation of enterprise technology. Validation master has the ability to integrate out of the box with a variety of external test automation systems and other tools designed to accelerate validation. ValidationMaster 2015™ is integrated with performance management tools such as HP load runner and NeoLoad. It also easily integrates with IBM rational function tester, a leading automated test engine and other validation tools.
ValidationMaster 2015™ is supported by two delivery models - on premise and hosted. The system is delivered in over 60 languages. ValidationMaster 2015™ also has a fully integrated validation master portal which includes critical quality features such as regulatory content management, audit management, risk management, corrective and preventive actions (CAPA), and a full functioning dashboard for real-time validation intelligence.
ValidationMaster 2015™ represents a paradigm shift in the way validation projects are conducted. The system is designed to track and manage all types of validation and is also accessible via Windows, android, or Apple devices.
OnShore Launches Chicago-based Validation Center of Excellence
January 1, 2015
In recognition that traditional validation practices can no longer keep pace with the rigorous demands of life sciences companies that deploy cloud, mobility, and on premise applications and highly regulated environments. To accelerate validation and quickly deliver mission-critical enterprise applications, OnShore Technology Group is pleased to announce the launch of the ValidationMaster™ Testing Center of Excellence (VMCoE). The VMCoE will serve the needs of the life sciences, government and technology sector communities seeking outsourced testing services. The testing center of excellence will deliver bottom-line results by helping global organizations optimize testing resources and deliver quality software and highly regulated environments.
The ValidationMaster™ Testing Center of Excellence is a virtual command center that leverages lean validation methodologies, automation, and best practices to ensure success. Utilizing validation master, onshore provides unprecedented visibility into the level of quality of any validation project allowing validation engineers to make informed risk-based decisions in a timely manner.
“We believe that a trusted service provider such as OnShore can deliver resources, knowledge, and best practices to help ensure success”, said Valarie King Bailey, CEO of OnShore Technology Group. “Organizations today are forced to do more with less. Our ValidationMaster™ Testing Center of Excellence stands in the gap to help those organizations optimize their resources while ensuring compliance, she continued.
Through the ValidationMaster™ Testing Center of Excellence we can test any enterprise or desktop application and provide comprehensive test results attesting to the quality and stability of these critical applications. Our ValidationMaster™ Testing Center of Excellence provides a cost-effective way to help reduce software failures and identify issues to ensure production readiness. For more information on the ValidationMaster™ Testing Center of Excellence contact us today.