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.
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).
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.
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.
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.
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.
