Full-Service Application Management and Technical Support

Full-Service Application Management and Technical Support

Oct 7, 2022

Application Management and Technical Support

PSC Biotech supports the client by providing a wide range of support services for their software platform.

  • Area: San Francisco Bay Area
  • Project Type: Application Management, Technical Support and Training Services
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About this Project

OBJECTIVE

The goal of this project is to provide a wide range of application services to the client.

SERVICES

PSC Biotech support the client by providing high quality, high value application services that ensure client’s application platform evolves to support their changing business priorities. Some of the deliverables of the project include:

  • Develop, update and present training materials that reflect the business use of the system at client site.
  • Manage user accounts, application configuration, and other system administration tasks.
  • Provide technical support in response to client user requests, including using the client’s application to manage and track support issues.
  • Provide solutions to simple through highly complex technical issues of significant scope; often requiring innovative and creative approaches and solution
  • Provide leadership (technical and project management) for significant change controls, enhancements, report development projects, configuration development, etc.
  • Lead technical projects to a successful conclusion, assisting the client team to develop and implement project plans, work schedules, etc.
  • Provide technical expertise in the implementation of new software versions, fixes, new or revised workflows, etc.

Project Success

The project is an ongoing success. PSC provides high quality support services to ensure client’s application efficiently meets their business needs.

 

 

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Validation, Audit, and Technical Management services

Validation, Audit, and Technical Management services

Oct 7, 2022

Validation, Audit, and Technical Management

services

PSC Biotech® provided validation services for Reflex UDI project for the client.

  • Area: Texas
  • Project Type: Quality Assurance 
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About this Project

OBJECTIVE

This project aimed to provide validation and Engineering support for the Reflex UDI Machine Qualification project.

SERVICES

PSC shall complete the following tasks as part of the validation and engineering support for the client, the key deliverables of this project included:

  1. Risk Assessment
  2. Functional Requirement Specification (FRS/FDS)
  3. Installation and Operational Qualification (IOQ)
  4. Development of Execution/ exceptions/ Reports
  5. Configuration Specification
  6. Trace Matrix (TM)
  7. Development of SOPs and relevant forms or documents.

PSC also supported the client with project management in the execution of this project.

Project Success

This project was completed successfully as per client specifications and in the expected time for completion.

 

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Engineering and CQV Services for Pharmaceutical Client

Engineering and CQV Services for Pharmaceutical Client

Oct 6, 2022

Engineering and CQV Services for Pharmaceutical Client

PSC Biotech® provided Engineering, Commissioning, Qualification and Validation services for the client reactor at pilot facility.

  • Area: Texas
  • Project Type: Engineering, Commissioning, Qualification, Validation
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About this Project

OBJECTIVE

The goal of this project was to provide Engineering, Commissioning, Qualification and Validation Services for upgrading and qualification for 50 L Reactor at the clients Pilot Manufacturing site.

SERVICES

PSC Biotech supported with the qualification, commissioning, validation, and other Engineering for 50L Reactor. As part of this project, PSC supported the Validation Protocol development, developing Qualification Plan, developing initial qualification documentation, execution, and final reports for different equipment and processes. PSC also supported in developing or updating of relevant SOPs for this project. Apart from Quality Assurance and technical writing support, PSC helped in the smooth planning and execution of the project through its project management expertise.

Project Success

The client was very happy with the smooth execution of all the deliverables as well as PSC’s support with documentation as well as project management aspects within the specified timeframe.

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 Validation (IQ, OQ, and PQ) of the HVAC system Reconnection

 Validation (IQ, OQ, and PQ) of the HVAC system Reconnection

Dec 8, 2021

Validation (IQ, OQ, and PQ) of the HVAC system Reconnection    

Requalification of the HVAC system 

  • Area: Zhubei, Hsinchu County, Taiwan
  • Project Type: Qualification
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About this Project

OBJECTIVE

Qualification protocol and summary generation, and qualification execution. 

SERVICES

PSC Biotech® delivered a detailed service quotation including personnel, transportation, and accommodation to our client, a global biopharmaceuticals development and manufacturing company located in Taiwan. With a complete understanding the client’s needs from the start, this quotation led to a useful for the verification of actual project cost.  

PSC Biotech provided exceptional professionalism in project planning and time management, qualification document designing, and the executive power of completing qualification tests and solving qualification deviations. 

The project progressed smoothly, and although operating on a tight 3-month project schedule, PSC Biotech completed this project on budget and ahead of schedule.  

Project Success

The project successfully completed ahead of schedule.

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Temperature Controlled Chamber Qualification

Temperature Controlled Chamber Qualification

Dec 2, 2021

Temperature Controlled Chamber Qualification 

PSC consultants performed qualification protocol and summary generation, and qualification execution.

 

  • Area: Orange County, CA
  • Project Type: CQV and Metrology
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About this Project

OBJECTIVE

To qualify multiple refrigerated trailers for controlled-temperature storage.

SERVICES

PSC Biotech provided CQV and Metrology services for this project. Client required rapid use of refrigerated storage trailers to handle warehouse overload. Each trailer required sensor calibration, engineering study for temperature profile, installation qualification, and operational qualification with temperature mapping. PSC consultants performed the calibration, ran engineering studies, wrote and executed qualification protocols, resolved deviations, and closed out reports. 

  

Equipment Used

Project Success

 PSC consultants engaged quickly with client needs, adapted to shifting priorities, and delivered trailers to meet client-controlled temperature storage requirements. 

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