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

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

Jan 5, 2023

CSV | Ireland +

California  |  Full Spectrum Projects

10 Years of Required CSV Support From PSC®

CSV | Ireland +

California  |  Full Spectrum Projects

10 Years of Required CSV Support From PSC®

About this Project

OBJECTIVE

CSV Support Projects

SERVICES

PSC® executes approximately 40 CSV projects per annum across the full spectrum of systems (bench-top instruments through enterprise applications such as ERP, DCMS, and QMS. The PSC® Service Lead manages account (budgets, resources) and provides CSV Subject Matter Expert input. For various CSV projects, PSC® has provided the client with validation plans, risk assessment, HPQC Support, and test script development. Additionally, PSC® has developed installation/operation/performance qualification protocols for the client.

Heather Kelly

President, PSC Europe

sales@biotech.com

Justin Cantor

Gary Marshall

Director of Regional Operations

sales@biotech.com

PROJECT SUCCESS

For over 10 years, PSC® has exclusively provided all CSV support for this client. PSC® hired 10-15 local CSV resources per project to strictly maintain the project schedule, execute the project, and adhere to the project budget for successful completion.

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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
Schedule a Consultation

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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Technical Writing for San Francisco Biotech Company

Technical Writing for San Francisco Biotech Company

Oct 7, 2022

Technical Writing for SF Biotech Client

PSC Biotech provided Technical Writing services to the client for their Facilities and Engineering Operations.

  • Area: San Francisco Bay Area
  • Project Type: Technical Writing
Schedule a Consultation

About this Project

OBJECTIVE

The goal of this project is to provide technical writing services for the development and review or modification of SOPs for the client’s facilities and laboratories.

SERVICES

PSC Biotech helps the client by generating and completing new SOPs as well as reviewing, updating and completing pre-existing SOPs for their facilities and laboratories. Examples of the SOPs that need to be developed include:

  • Access Badge Requirements
  • Power Outage Response
  • Utilities and Equipment Alarm Response
  • Staff Onboarding and Offboarding
  • Incubator PM and Calibration
  • Freezer Maintenance

Project Success

The project is an ongoing success, PSC has completed all assigned SOPs within the client’s schedule.

 

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Software Validation

Software Validation

Oct 7, 2022

Software System Validation 

PSC Biotech provided eight years of Computer System Validation (CSV) services to the client during development and commercialization.

  • Area: Bay Area
  • Project Type:Computer System Validation (CSV)
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About this Project

OBJECTIVE

The goal of this project is to provide computer system validation (CSV) services for software developed and commercialized by the client.

SERVICES

PSC Biotech provided the client the following:

  • Development of Installation (IQ) and Operational Qualification (OQ) Test Scripts for the client’s Software as a Service (SaaS) application
  • Execution and Post Execution Review of IQ and OQ Test Scripts
  • Development of a Traceability Matrix
  • Development of System Release Memo

Project Success

The project is an ongoing success, PSC executes and completes the CSV services, ensuring the client can release its application on schedule, 3 times per annum and maintains an excellent level of regulatory compliance.  .

 

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Computer System Validation (CSV) Services

Computer System Validation (CSV) Services

Oct 7, 2022

Computer Systems Validation (CSV) Services 

For over 10 years, PSC Biotech has been the primary Computer Systems Validation provider for this pharmaceutical client. 

  • Area: Bay Area
  • Project Type:Computer System Validation (CSV)
Schedule a Consultation

About this Project

OBJECTIVE

Computer System Validation (CSV) is the process of providing documented evidence that a computer system performs exactly as intended. The goal of this project has been to provide ongoing computer system validation services to the client, covering a wide range of enterprise and desktop applications

 

SERVICES

PSC Biotech partners with the client to provide the following:

 

DELIVERABLES

The project deliverables include:

  • Preparation of validation plans, specifications, support with relevant project meetings/ strategy and planning
  • Development and execution of Installation, Operational and Performance Qualifications
  • Preparation of Traceability Matrix, summary reports and other CSV documentation as required by the client.
  • Business Requirements, workflows, project plans.

Project Success

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

 

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