Author: Fynyty

Client onboarding scope of services includes:

A. Project Management and Technical support provided to execute the following:

1. Experienced information technology resources, and engineering team for the engagement as business and project requirements dictate.
2. Implementation of Project Playbook covering all required tasks, activities, and milestones.
3. Loading of all master data / SKU’s into the new systems, Validation and Production environments.
4. Perform investigations and troubleshoot to resolve EPCIS file transmission issues and communicate with the client’s CMO and 3PL’s to ensure data is transmitted properly.
5. Client technical training.

B. Quality Documentation

1. RemTech will review all L4 Specifications:
   • User Requirement Specification
   • Functional Specification
   • Configuration Specification/Design Specification
2. RemTech will author Validation Protocols:
   • Validation Environment Installation Qualification
   • Validation Environment Operational Qualification (including User Acceptance Test if necessary)
   • Production Environment Performance Qualification (only when CMO does not provide)
3. RemTech will author Summary Reports or review and approve CMO Production Reports:
   • Validation Environment IQ/OQ Summary Report
   • Production Environment PQ Summary Report

Client monthly support scope of services includes:

C. L4 Monthly Hosting:

1. Monthly hosting of client’s system
2. Support tickets / engineering base level support
3. Week to week verification of file management
4. Management (EPCIS Inbound and Outbound) / updates to master data
5. 3PL Outbound EPCIS Management

For more information contact:

Johnny Colvin: jcolvin@remtechllc.com, (c) 256-975-8877

www.remtechllc.com

Every successful project starts with a great foundation. At RemTech, our foundation is built on the engineers, consultants, administrators, and others that make our team great. We would like to take this opportunity to introduce you to another great member of the RemTech team: Andrew Weldon

Andrew is a natural leader and that shines through in the various roles that he has taken on over the years. He has an extensive background working with international organizations and clients. In these organizations, he has held a number of managerial and technical roles. Throughout these roles, Andrew has developed exceptional communication skills. He has the ability to share his knowledge with colleagues and clients in a clear and effective manner.

While he specializes in Drug Product facilities, Andrew has experience in a variety of fields. With his proven track record of delivering successful projects to clients and his experience in international guidance and regulatory requirements, Andrew adds a unique perspective to the RemTech team. Currently, Andrew is working as a commissioning and qualification manager, assisting a pharmaceutical company as they are launching a new facility.

Andrew is a valuable member of our team at RemTech, adding his individual expertise and insight to our organization. He enjoys the opportunity to work in a highly technical environment and knowing that the projects he works on can make a meaningful difference for patients around the world. We are proud to work alongside him and have him on our team.

A child’s first step is an exciting thing. It’s a milestone every parent looks forward to seeing. But no one wants their child to stop there. We hope to see our children take more steps and continue to grow with each passing day.

Deciding to start a new project for your organization is the first step, so what comes next? Partnering with RemTech to walk you through the planning and implementation.

Planning

RemTech’s Project Managers work with you to develop a specialized plan to ensure the successful implementation of your new project. From building projects to implementing a new process to the procurement and installation of new equipment, our consultants join with your team from start to finish.

Balancing your budget, the schedule, and the scope of your project is an important factor in the planning process. We work with you to set realistic and attainable goals for your project.

Implementation

After the planning phase is completed, we move to implement that plan. This can look different based on what kind of project you are starting. In some cases, we will begin to find and work with contractors to move forward with a building project. If your project requires new equipment, we work to procure the equipment that best suits your needs. Then we provide training and validation for the equipment to ensure long-term success.

We become a part of your team to build you up from within. We work to further strengthen the areas in which you excel and to provide support in areas where there is opportunity. RemTech’s Project Managers are dedicated to your success.

From start to finish, our Project Managers work side by side with you to reduce the stress of a new project. Contact us today and take the next step with RemTech.