Computer System Validation for a pharmaceutical client

Computer System Validation for a pharmaceutical client

Computer system Validation for a pharmaceutical client in Bothell, Seattle. 

PSC Biotech® provided computer system validation service for a client at their facility. 

  • Area: Bothell, Washington
  • Project Type: Computer System Validation


About this Project

OBJECTIVE

Installation and qualification documents for the new UDI Carton Printer and Verification Systems. 

SERVICES

There were different stages in the installation and qualification of documents related to the UDI Carton Printer and Verification systems. We wrote all the User Requirement Specifications (URS’s), FDS’s, IOQ’s and TM’s for the system. In addition, we also created all the Equipment Identification Forms (EID) and Standard Operating Procedures (SOPs). Next, we developed and installed recipes and performed troubleshooting with their automation engineers during the execution phases of the project. Lastly, we trained production personnel on the operation of the UDI Carton Printer & verification Systems. 

PROJECT SUCCESS

The client was very satisfied with the outcome and praised PSC Biotech for its professionalism, expertise and customer-centric approach. The project was completed on time and within budget, and we are very happy with the outcome. 

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Commissioning, Qualification, Validation and Engineering services for the clients  facility since its inception.

Cleaning Validation & Decommissioning Project

PSC hired a validation specialist who stayed within budget and the time frame set originally by PSC and the client.

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Successful completion of a validation support project

Successful completion of a validation support project

Validation support for a Biotech Client.

PSC Biotech® provides validation support for a Biotechnology client in Rockville, Maryland.  

  • Area: Rockville, Maryland
  • Project Type: Spreadsheet Validation  

About this Project

OBJECTIVE

This project aimed to provide a complete spreadsheet validation package (including the master plan, Risk Assessments, User Requirements Specifications, Protocols, Executions, Trace Matrices, and Summary Reports) for all Excel spreadsheets used in the laboratories for GMP purposes.  

SERVICES

PSC Biotech consultants drafted the required validation lifecycle documents and provided technical consultation and support for the project.  The spreadsheets contained simple to complex calculations and formulae used to generate laboratory results and determine passing or failing criteria that directly impact patient health and product quality. 

PROJECT SUCESS

The project is currently ongoing, and the client is satisfied with PSC Biotech’s support and consultation for the project.  The client has particularly mentioned PSC Biotech’s professionalism and technical knowledge.  

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20 Years & Counting of CQV Services

Commissioning, Qualification, Validation and Engineering services for the clients  facility since its inception.

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Full-Service Application Management and Technical Support

Full-Service Application Management and Technical Support

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

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.

 

 

Related Projects

20 Years & Counting of CQV Services

Commissioning, Qualification, Validation and Engineering services for the clients  facility since its inception.

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PSC hired a validation specialist who stayed within budget and the time frame set originally by PSC and the client.

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The operations performed included: Filling, Parts Preparation, Formulation, Filling, Process Support Systems and Cleaning.

How Can We Help You?

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Technical Writing for San Francisco Biotech Company

Technical Writing for San Francisco Biotech Company

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

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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How Can We Help You?

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Software Validation

Software Validation

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)

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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How Can We Help You?

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