OUR PROJECTS
Our Service Related Projects
PAST PROJECTS
PAST PROJECTS
CSV, Project Summary
Nov 7, 2023
Computer System Validation for a Pharmaceutical Client
PSC Biotech experts were assigned to commission the architectural finish and mechanical completion of the Manufacturing Science and Technology (MSAT) Laboratory. The commissioning took place parallel with the final construction process.
Commissioning, Project Summary, Qualification, Validation
Oct 23, 2023
Commissioning of the new manufacturing science and technology (MSAT) lab.
PSC Biotech experts were assigned to commission the architectural finish and mechanical completion of the Manufacturing Science and Technology (MSAT) Laboratory. The commissioning took place parallel with the final construction process. This helped our CQV experts to directly start and complete the project.
Commissioning, Project Summary, Qualification, Validation
Oct 17, 2023
Commissioning Of The New Apheresis Inspection And Processing Spaces
The commissioning team successfully completed the modifications to the air handling system according to the client’s specifications and design. They checked the changes to the supply and return ductwork, as well as the new and existing variable air volume boxes.
Project Summary, Spreadsheet Validation
Jul 21, 2023
Successful Completion Of A Validation Support Project
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.
Engineering, Project Summary
Jul 21, 2023
Engineering Support For A Bio-Pharmaceutical Client
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).
Installation and Operational Qualification, Project Summary
Jul 21, 2023
Equipment Installation And Operational Qualification Project
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).
Project Summary, Quality Remediation
Jul 17, 2023
Quality Remediation Support
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.
Installation and Operational Qualification, Project Summary
Jul 7, 2023
Equipment Installation And Operational Qualification For A Medical Device Client
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).
Project Summary, Validation Support
Jul 1, 2023
Validation Support For A Biotechnology Client
PSC Biotech professionals supported the client by clarifying the validation work in the near term. This allowed the product development team to soft launch their product. We identified the scope of work and checked the required validation before the soft launch of the product.
Data Migration, Project Summary
Jun 23, 2023
Data Migration
PSC Biotech supported the client with downloading files from the company’s previously used ELN to a new ELN system in a GxP and non-GxP environment. We made sure the downloaded files were not corrupted, converted any file as needed and reuploaded the experiment data to the ELN system.
Project Summary, Quality Assurance
Jun 9, 2023
Quality Document Review
PSC Biotech supported the client with Quality Assurance (QA) and document review for the projects and manufacturing procedures. Our work and procedures met company and regulatory standards. A few quality issues were identified, which were resolved by our team.
Project Summary, Qualification
Jan 5, 2023
Validation (IQ, OQ, AND PQ) Of The Hvac System Reconnection
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.
Project Summary, Quality Assurance
Oct 7, 2022
Validation, Audit, And Technical Management 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:
Computer System Validation (CSV), Project Summary
Oct 7, 2022
Computer System Validation (CSV) Services
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.
Computer System Validation (CSV), Project Summary
Oct 7, 2022
Software Validation
The goal of this project is to provide computer system validation (CSV) services for software developed and commercialized by the client.
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HOW CAN WE HELP YOU
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