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Arivium assessed each computerized system for applicability to the regulations and the developed a plan and integrated necessary changes to the applicable systems.

 

 

 

 

 

 

 

 

 

Arivium coordinated a team charged with redesigning the business practices across multiple business units.

 

 

 

 

 

 

 

 

 

 

 

 

 
Facilitating processes and designing solutions for a variety of industries

Arivium has lent its expertise to a variety of significant projects using its flexible approach to implementing and managing technology to meet a businesses needs. Some recent examples are included here.

Global Pharmaceutical Manufacturer
Global Pharmaceutical Manufacturer
Life Sciences Research Institution
Royalty Management Provider
Application Management Clients


Global Pharmaceutical Manufacturer

Problem
This global pharmaceutical manufacturer needed to remediate its computerized systems to comply with federal regulations pertaining to electronic records and electronic signatures.

Solution
Arivium assessed each computerized system for applicability to the regulations and the developed a plan and integrated necessary changes to the applicable systems. Additionally, the validation master plan, which governs the method by which each system would be validated, was developed. At the same time, we worked with the Quality Assurance unit to ensure compliance of each system by developing qualification protocols and executing such according to the validation master plan.

Arivium's Role
  • Provide a Technical Analyst responsible for assessing systems applicability and planning modifications to each for technical compliance.
  • Provide a Project Manager to estimate effort associated with remediation, and coordinate and manage execution of remediation plans.
  • Provide an Application Developer to design and develop systems according to business, technical, and regulatory requirements.
  • Provide a Validation Analyst to develop and execute protocols for qualifying each system, and to document the validation suite for each.
  • Serve as Vendor Manager responsible for coordinating vendor work involved in remediation projects.

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Global Pharmaceutical Manufacturer

Problem
This global pharmaceutical manufacturer needed to implement the company standard manufacturing management system and formally retire systems that are replaced as a result of the standard manufacturing system implementation.

Solution
Arivium coordinated a team charged with redesigning the business practices across multiple business units. This team defined configuration requirements for, and implement into, the new manufacturing system. Additionally, the team designed and developed system customizations, interfaces, and reports to support operations with the new system and then planned, designed, and developed data migration and conversion processes from the legacy systems to the new system.

Finally, the team defined a strategy for retiring systems according to corporate, legal, and regulatory standards and then executed retirement plans to formally decommission systems that were displaced. This was achieved be working with the local Quality Assurance unit and corporate leaders to ensure compliance of each decommissioned system by developing and executing protocols for each retirement according to the decommissioning strategy.

Arivium's role
  • Provide a Technical Analyst to lead the design and development of system modifications.
  • Provide a Project Manager to define resource requirements, estimate and assign work, plan and obtain resources, and manage execution of project tasks.
  • Provide a Technical Team Leader to coordinate work with other project teams, including compliance, business representatives, and program management.
  • Serve as Environment Manager to coordinate use of and synchronization across the various environments used for designing, developing, and testing system functions.
  • Provide a Project Manager responsible for defining the system decommission strategy, building the team to execute the strategy, and managing the execution of each system retirement plan.

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Life Sciences Research Institution

Problem
This world-leading life sciences research institution needed to design and develop a system to aid in the research of disease and corresponding treatments. Additionally, the institute wanted to commercialize the system for re-licensed use by research scientists, clinicians, and physicians to help develop and apply treatments.

Solution
Arivium worked side by side with this institute to design and develop a system to facilitate analysis of disease and treatments. The team of experts from Arivium worked with system inventors to complete functionality, design and architect the system to be commercially viable, and identified potential system interfaces by working with both prospective end-users and vendor partners.

Arivium's Role
  • Serve as System Architect responsible for co-developing the system, working with inventors and technical experts to develop system functions in a supportable architecture.
  • Provide a Lead Developer responsible for building and testing specific system functions.
  • Provide a Commercialization Director responsible for working with institute leaders to define the license agreement by which the system will be re-licensed to end-users.
  • Serve as Program Manager responsible for coordinating development and integration activities across releases, and facilitating appropriate resources to deliver as required.

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Royalty Management Provider

Problem
To support contract administration and royalty management business practices with a system that scales to extended groups of end-users and to support business practices and policies, and maintain the system with enhancements and increased functionality.

Solution
Arivium worked to design and develop a contract and royalty management system by working with end-users to complete system functionality and streamline business processes across the entire user population. Arivium also designed and architected the system to be commercially viable and supportable for disparate user groups. Finally, our team led user groups to determine enhancement priorities and to schedule future releases.

Arivium's Role
  • Serve as System Architect responsible for developing the system, working with end users and process experts to develop system functions in a supportable architecture.
  • Provide a Lead Developer responsible for building and testing specific system functions.
  • Provide a Lead Analyst working with users and policy makers to determine and design system functionality and corresponding policies.
  • Serve as Program Manager responsible for coordinating development and integration activities across releases, and facilitating appropriate resources to deliver as required.

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Application Management Clients

Problem
To support end-users and provide technical support for applications in production.

Solution
Arivium partnered with the various clients in this category to provide technical support, and to work with hosting providers to ensure that systems are operational for end-users. Additionally, Arivium assisted in the transition of systems to hosting environments for production use. Finally, we worked with other system vendors to design and implement systems in new hosting environments, both locally and at corporate headquarters located outside of the United States.

Arivium's Role
  • Serve as System Architect responsible for developing the system, working with end-users and process experts to develop system functions in a supportable architecture.
  • Provide a Lead Developer responsible for building and testing specific system functions.
  • Provide a Lead Analyst working with users and policy makers to determine and design system functionality and corresponding policies.
  • Serve as Program Manager responsible for coordinating development and integration activities across releases, and facilitating appropriate resources to deliver as required.

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