WHEN RESULTS MATTER

 

Independent Verification and Validation (IV&V) processes provide a high degree of assurance throughout the implementation and deployment of enterprise technologies both in the cloud and on-premise. OnShore Technology Group has been privileged to work with global companies across the globe to support the validation and verification of mission-critical enterprise technologies. The case studies featured below represent a snapshot of the projects we worked on and the results delivered for our clients.

WE PRACTICE LEAN VALIDATION. With each project, we endeavor to save our clients time and money while ensuring compliance. Each engagement is consistent in quality and unique in our approach as we provide individual services to each of our clients across the globe. From the development of SOPs for validation governance to the turnkey delivery of a fully validated system, OnShore is relentless in our pursuit of quality and compliance. Check out our case studies below to learn more about the results we have achieved for our clients. When all is said and done, results do indeed matter.

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Global Healthcare Company

 

Global Healthcare Company

Click Above to Learn how a global healthcare company used lean validation and automation to validate their system on time and within budget.

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Global Pharma Company

 

Global Pharma Company

A Global Pharmaceutical Company lacked internal resources for validation. Learn how OnShore's turnkey validation services helped deliver a fully validated system.

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Multinational Medical Device Company

 

Multinational Medical Device Company

A multinational medical device manufacturer was seeking to validate a highly customized COTS ERP system. With few internal resources and an aggressive timeline, learn how they leveraged outsourced, turnkey IV&V services for quality and compliance .

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EU Pharma Company

 

EU Pharma Company

An EU pharma company expanded business operations to distribute its products across the globe.  They sought to implement a supply chain management system in compliance with global requirements and fully validated.

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Compound Pharmacy Company

 

Compound Pharmacy Company

503A/503B compound pharmacies has been under scrutiny and increased regulatory pressure since the NECC tragedy. GMP and validation are essential. Learn how we worked with a compound pharmacy to deliver a turnkey, validated ERP system.

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Innovative Biotechnology Company

 

Innovative Biotechnology Company

A pre-market biotechnology company was seeking to implement and validate a supply chain system in preparation for first customer ship. Learn how OnShore leveraged automated validation lifecycle management and professional services to deliver a turnkey validated system just in time for initial product launch.

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Global Nutraceutical Company

 

Global Nutraceutical Company

In June 2010, the GMPs were required for nutraceuticals. Learn how a global company with no written policies and procedures in place for validation leveraged OnShore's experience and regulatory knowledge to establish SOPs and conduct the full validation of the system in compliance with new regulatory requirements.

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Dental Products Manufacturer

 

Dental Products Manufacturer

A major dental products manufacturer sought to improve quality and compliance across the organization. The company required updated SOPs as well as turnkey validation. Learn how automated lean validation processes and best practices took this manufacturer to the next level.

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Global Grain Manufacturer

 

Global Grain Manufacturer

A global grain manufacturer sought to streamline their testing and reduce the FTE impact that negatively impacted their regression testing process. Learn how this company leveraged ValidationMaster's FULLY AUTOMATED testing capabilities to create automated scripts that could be run without human intervention at specified time intervals.

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Global Tobacco Company

 

Global Tobacco Company

Tobacco companies are now subject to GMPs. Learn how a major tobacco manufacturer prepared their organization for GMP and quality.