Equipment Installation and Operational Qualification Project

Equipment Installation and Operational Qualification Project

Jul 21, 2023

Equipment Installation and Operational Qualification for a Medical Device Client

PSC Biotech® provided equipment installation and operational qualification support for a medical device client.  

  • Area: Washington, D.C
  • Project Type: Installation and Operational Qualification 


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About this Project

OBJECTIVE

The objective of this project was to provide installation and operational qualification support for a benchtop autoclave.  

SERVICES

PSC Biotech experts supported the client by verifying the installation of all equipment, controls, and programming necessary to provide consistent sterilization of glass and wrapped items. Our experts ensured the system complied with relevant current good manufacturing practices (cGMP). We also ensured that all documents are available to enable the equipment and associated programmable logic controller to be operated and maintained safely, effectively, and consistently. We calibrated all the equipment prior to operational qualification and verified the operational aspects of the system deemed critical to its satisfactory performance.  

PROJECT SUCCESS

The client is satisfied with the installation and verification and has praised PSC Biotech‘s professionalism and expertise. We are in the final stages of the project and awaiting pressure loggers to finish the qualification. 

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Engineering Support for a Bio-Pharmaceutical Client

Engineering Support for a Bio-Pharmaceutical Client

Jul 21, 2023

Engineering Support for a Bio-Pharmaceutical Client

PSC Biotech® provided engineering support for a Bio-Pharmaceutical client in San Francisco, California.  

  • Area: San Francisco, California
  • Project Type: Engineering

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About this Project

OBJECTIVE

This project aimed to provide engineering support for a new filing line. 

SERVICES

PSC Biotech team supported the client by initially reviewing and providing advice on the design documents, i.e., functional specifications (FS), hardware design specifications (HDS), automation concepts, software design specifications (SDS), and computer specifications (CS).  Our experts mapped the critical quality attributes (CQA) against the process parameters identified by the critical process parameters (CPPs), and generated system impact assessment (SIA) and critical component assessment (CCA). We also participated in design review meetings with the equipment suppliers and provided our expert advice on the design elements. Our team drafted the quality events such as change control for new and legacy equipment removal and installation, demolition, and remodeling of good manufacturing practices (GMP) and non-GMP rooms. 

PROJECT SUCCESS

The project was completed, and the client was satisfied with the goals achieved.  

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Successful completion of a validation support project

Successful completion of a validation support project

Jul 21, 2023

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  

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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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Quality Remediation Support

Quality Remediation Support

Jul 17, 2023

Project Management for a Biotech Client.

PSC Biotech® provided quality remediation support for a Biotech client.  

  • Area: Pomona
  • Project Type:Quality Remediation 
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About this Project

OBJECTIVE

The objective of this project was to migrate the data from master control to Veeva and Laboratory Management System (LMS) implementation. 

SERVICES

PSC Biotech specialists supported the client by migrating the data from Master Control to Veeva ensuring data integrity. We also helped the client migrate training records and set up the curriculum. In addition, we also provided insight and timeline on the electronic document management system (EDMS) and reviewed validation deliverables on the data migration. We assessed potential destination systems for the migration and managed integration tasks of the master control training record migration into LMS success factor and provided resource loading for clients on specific tasks.  

PROJECT SUCCESS

The project was completed, and the client was satisfied with the achieved goals. The project success was recognized by the quality assurance (QA) and the executive team members.  

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Equipment Installation and Operational Qualification for a Medical Device Client

Equipment Installation and Operational Qualification for a Medical Device Client

Jul 7, 2023

Equipment Installation and Operational Qualification for a Medical Device Client

PSC Biotech® provided equipment installation and operational qualification support for a medical device client.  

  • Area: Washington, District of Columbia (D.C.)
  • Project Type:Installation and Operational Qualification 
Schedule a Consultation

About this Project

OBJECTIVE

This project aimed to provide installation and operational qualification support for a benchtop autoclave.  ​

SERVICES

PSC Biotech experts supported the client by verifying the installation of all equipment, controls, and programming necessary to provide consistent sterilization of glass and wrapped items. Our experts ensured the system complied with relevant current good manufacturing practices (cGMP). We also ensured that all documents were available to enable the equipment and associated programmable logic controller to be operated and maintained safely, effectively, and consistently. We calibrated all the equipment before operational qualification and verified the operational aspects of the system deemed critical to its satisfactory performance.

Project Success

The client is satisfied with the installation and verification and has praised PSC Biotech‘s professionalism and expertise. We are in the final stages of the project and awaiting pressure loggers to finish the qualification. 

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